Trial Outcomes & Findings for To Evaluate the Safety, Tolerability, and Immunogenicity of BNT162b2 Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older (NCT NCT04754594)
NCT ID: NCT04754594
Last Updated: 2024-12-06
Results Overview
Pain at injection site, redness \& swelling were recorded by participants in an electronic diary (e-diary). Redness \& swelling were measured \& recorded in measuring devise units (range 1 to 21) then converted to cm. 1 measuring device unit = 0.5 cm \& graded as mild: \> 2.0 to 5.0 cm, moderate: \> 5.0 to 10.0 cm, severe: \> 10.0 cm, grade 4 (potentially life threatening): necrosis or exfoliative dermatitis (redness) \& necrosis (swelling). Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity \& grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Reactions reported as adverse events in the case report form within 7 days after the study vaccination were also included in the analysis. Exact 2-sided 95% confidence interval (CI) was based on Clopper \& Pearson method.
COMPLETED
PHASE2/PHASE3
726 participants
From Day 1 to Day 7 after dose 1
2024-12-06
Participant Flow
This study was conducted in 2 periods-Blinded Period (from Day 1 to 1 month post-delivery) and Unblinded Period (1 to 6 Months Post-Delivery for those maternal participants who initially received BNT162b2 and from first dose of BNT162b2 to 1 month after second dose of BNT162b2 for those maternal participants who initially received placebo).
A total of 726 participants were enrolled in this study. 391 were maternal participants who signed informed consent form and were enrolled out of which 41 were screen failures and 2 participants were not randomized. Eventually 348 maternal participants were randomized to receive treatment. 335 were infants born to maternal participants.
Participant milestones
| Measure |
Maternal Participants: BNT162b2 30 mcg
Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.
|
Maternal Participants: Placebo Then BNT162b2 30 mcg
Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. After unblinding at 1 month post-delivery, participants were administered 2 doses of BNT162b2 vaccine as an intramuscular injection separated by 21 days. Participants were followed-up until 1 month after last dose of vaccination.
|
Infant Participants: BNT162b2 30 mcg
Infant participants who were born to maternal participants vaccinated with BNT162b2 30 mcg during pregnancy were included. Infant participants were followed up to 6 months of age.
|
Infant Participants: Placebo
Infant participants who were born to maternal participants vaccinated with placebo during pregnancy were included. Infant participants were followed up to 6 months of age.
|
|---|---|---|---|---|
|
Blinded Period
STARTED
|
174
|
174
|
0
|
0
|
|
Blinded Period
Vaccination 1
|
173
|
173
|
0
|
0
|
|
Blinded Period
Vaccination 2
|
170
|
170
|
0
|
0
|
|
Blinded Period
COMPLETED
|
161
|
159
|
0
|
0
|
|
Blinded Period
NOT COMPLETED
|
13
|
15
|
0
|
0
|
|
Unblinded Period
STARTED
|
167
|
162
|
0
|
0
|
|
Unblinded Period
Vaccination 3
|
0
|
152
|
0
|
0
|
|
Unblinded Period
Vaccination 4
|
0
|
148
|
0
|
0
|
|
Unblinded Period
COMPLETED
|
151
|
147
|
0
|
0
|
|
Unblinded Period
NOT COMPLETED
|
16
|
15
|
0
|
0
|
|
Infant Participants
STARTED
|
0
|
0
|
167
|
168
|
|
Infant Participants
COMPLETED
|
0
|
0
|
152
|
139
|
|
Infant Participants
NOT COMPLETED
|
0
|
0
|
15
|
29
|
Reasons for withdrawal
| Measure |
Maternal Participants: BNT162b2 30 mcg
Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.
|
Maternal Participants: Placebo Then BNT162b2 30 mcg
Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. After unblinding at 1 month post-delivery, participants were administered 2 doses of BNT162b2 vaccine as an intramuscular injection separated by 21 days. Participants were followed-up until 1 month after last dose of vaccination.
|
Infant Participants: BNT162b2 30 mcg
Infant participants who were born to maternal participants vaccinated with BNT162b2 30 mcg during pregnancy were included. Infant participants were followed up to 6 months of age.
|
Infant Participants: Placebo
Infant participants who were born to maternal participants vaccinated with placebo during pregnancy were included. Infant participants were followed up to 6 months of age.
|
|---|---|---|---|---|
|
Blinded Period
Withdrawal by Subject
|
4
|
9
|
0
|
0
|
|
Blinded Period
Protocol Violation
|
2
|
2
|
0
|
0
|
|
Blinded Period
Lost to Follow-up
|
1
|
1
|
0
|
0
|
|
Blinded Period
Unblinded before 1-month postdelivery visit
|
6
|
3
|
0
|
0
|
|
Unblinded Period
Withdrawal by Subject
|
6
|
8
|
0
|
0
|
|
Unblinded Period
Lost to Follow-up
|
5
|
3
|
0
|
0
|
|
Unblinded Period
Protocol Violation
|
2
|
4
|
0
|
0
|
|
Unblinded Period
Other
|
3
|
0
|
0
|
0
|
|
Infant Participants
Withdrawal by Subject
|
0
|
0
|
9
|
17
|
|
Infant Participants
Lost to Follow-up
|
0
|
0
|
4
|
10
|
|
Infant Participants
Death
|
0
|
0
|
1
|
1
|
|
Infant Participants
Other
|
0
|
0
|
1
|
1
|
Baseline Characteristics
To Evaluate the Safety, Tolerability, and Immunogenicity of BNT162b2 Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older
Baseline characteristics by cohort
| Measure |
Maternal Participants: BNT162b2 30 mcg
n=173 Participants
Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.
|
Maternal Participants: Placebo Then BNT162b2 30 mcg
n=173 Participants
Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. After unblinding at 1 month post-delivery, participants were administered 2 doses of BNT162b2 vaccine as an intramuscular injection separated by 21 days. Participants were followed-up until 1 month after last dose of vaccination.
|
Infant Participants: BNT162b2 30 mcg
n=167 Participants
Infant participants who were born to maternal participants vaccinated with BNT162b2 30 mcg during pregnancy were included. Infant participants were followed up to 6 months of age.
|
Infant Participants: Placebo
n=168 Participants
Infant participants who were born to maternal participants vaccinated with placebo during pregnancy were included. Infant participants were followed up to 6 months of age.
|
Total
n=681 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
Less than (<) 18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
167 Participants
n=5 Participants
|
168 Participants
n=4 Participants
|
335 Participants
n=21 Participants
|
|
Age, Customized
Greater than or equal to (>=) 18 and <= 45 years
|
173 Participants
n=5 Participants
|
173 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
346 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
173 Participants
n=5 Participants
|
173 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
504 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
95 Participants
n=4 Participants
|
177 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
70 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
258 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
103 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
104 Participants
n=4 Participants
|
415 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
47 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
170 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
117 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
104 Participants
n=4 Participants
|
454 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Day 7 after dose 1Population: For maternal participants, safety population included all randomized participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" (N) signifies participants evaluable for this outcome measure. Human immunodeficiency virus (HIV) positive participants were excluded from analysis as pre-specified in the statistical analysis plan (SAP).
Pain at injection site, redness \& swelling were recorded by participants in an electronic diary (e-diary). Redness \& swelling were measured \& recorded in measuring devise units (range 1 to 21) then converted to cm. 1 measuring device unit = 0.5 cm \& graded as mild: \> 2.0 to 5.0 cm, moderate: \> 5.0 to 10.0 cm, severe: \> 10.0 cm, grade 4 (potentially life threatening): necrosis or exfoliative dermatitis (redness) \& necrosis (swelling). Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity \& grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Reactions reported as adverse events in the case report form within 7 days after the study vaccination were also included in the analysis. Exact 2-sided 95% confidence interval (CI) was based on Clopper \& Pearson method.
Outcome measures
| Measure |
Maternal Participants: BNT162b2 30 mcg
n=161 Participants
Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.
|
Maternal Participants: Placebo
n=163 Participants
Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.
|
|---|---|---|
|
Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1
Redness: Mild
|
2.5 Percentage of participants
Interval 0.7 to 6.2
|
0.6 Percentage of participants
Interval 0.0 to 3.4
|
|
Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1
Redness: Moderate
|
0.6 Percentage of participants
Interval 0.0 to 3.4
|
0 Percentage of participants
Interval 0.0 to 2.2
|
|
Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1
Redness: Severe
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0 Percentage of participants
Interval 0.0 to 2.2
|
|
Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1
Redness: Grade 4
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0 Percentage of participants
Interval 0.0 to 2.2
|
|
Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1
Swelling: Mild
|
4.3 Percentage of participants
Interval 1.8 to 8.8
|
0 Percentage of participants
Interval 0.0 to 2.2
|
|
Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1
Swelling: Moderate
|
0.6 Percentage of participants
Interval 0.0 to 3.4
|
0 Percentage of participants
Interval 0.0 to 2.2
|
|
Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1
Swelling: Severe
|
0.6 Percentage of participants
Interval 0.0 to 3.4
|
0 Percentage of participants
Interval 0.0 to 2.2
|
|
Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1
Swelling: Grade 4
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0 Percentage of participants
Interval 0.0 to 2.2
|
|
Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1
Pain at the injection site: Mild
|
59.0 Percentage of participants
Interval 51.0 to 66.7
|
9.8 Percentage of participants
Interval 5.7 to 15.5
|
|
Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1
Pain at the injection site: Moderate
|
23.6 Percentage of participants
Interval 17.3 to 30.9
|
0 Percentage of participants
Interval 0.0 to 2.2
|
|
Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1
Pain at the injection site: Severe
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0 Percentage of participants
Interval 0.0 to 2.2
|
|
Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1
Pain at the injection site: Grade 4
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0 Percentage of participants
Interval 0.0 to 2.2
|
PRIMARY outcome
Timeframe: From Day 1 to Day 7 after dose 2Population: For maternal participants, safety population included all randomized participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in the SAP.
Pain at injection site, redness \& swelling were recorded by participants in an e-diary. Redness \& swelling were measured \& recorded in measuring devise units (range 1 to 21) then converted to cm. 1 measuring device unit = 0.5 cm \& graded as mild: \> 2.0 to 5.0 cm, moderate: \> 5.0 to 10.0 cm, severe: \> 10.0 cm, grade 4 (potentially life threatening): necrosis or exfoliative dermatitis (redness) \& necrosis (swelling). Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity \& grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Reactions reported as adverse events (AEs) in the case report form (CRF) within 7 days after the study vaccination were also included in the analysis. Exact 2-sided 95% CI was based on the Clopper \& Pearson method.
Outcome measures
| Measure |
Maternal Participants: BNT162b2 30 mcg
n=148 Participants
Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.
|
Maternal Participants: Placebo
n=146 Participants
Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.
|
|---|---|---|
|
Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2
Redness: Mild
|
3.4 Percentage of participants
Interval 1.1 to 7.7
|
0 Percentage of participants
Interval 0.0 to 2.5
|
|
Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2
Redness: Moderate
|
2.0 Percentage of participants
Interval 0.4 to 5.8
|
0 Percentage of participants
Interval 0.0 to 2.5
|
|
Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2
Redness: Severe
|
0 Percentage of participants
Interval 0.0 to 2.5
|
0 Percentage of participants
Interval 0.0 to 2.5
|
|
Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2
Redness: Grade 4
|
0 Percentage of participants
Interval 0.0 to 2.5
|
0 Percentage of participants
Interval 0.0 to 2.5
|
|
Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2
Swelling: Mild
|
4.1 Percentage of participants
Interval 1.5 to 8.6
|
0.7 Percentage of participants
Interval 0.0 to 3.8
|
|
Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2
Swelling: Moderate
|
2.7 Percentage of participants
Interval 0.7 to 6.8
|
0 Percentage of participants
Interval 0.0 to 2.5
|
|
Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2
Swelling: Severe
|
0 Percentage of participants
Interval 0.0 to 2.5
|
0 Percentage of participants
Interval 0.0 to 2.5
|
|
Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2
Swelling: Grade 4
|
0 Percentage of participants
Interval 0.0 to 2.5
|
0 Percentage of participants
Interval 0.0 to 2.5
|
|
Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2
Pain at the injection site: Mild
|
54.7 Percentage of participants
Interval 46.3 to 62.9
|
12.3 Percentage of participants
Interval 7.5 to 18.8
|
|
Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2
Pain at the injection site: Moderate
|
19.6 Percentage of participants
Interval 13.5 to 26.9
|
4.1 Percentage of participants
Interval 1.5 to 8.7
|
|
Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2
Pain at the injection site: Severe
|
0.7 Percentage of participants
Interval 0.0 to 3.7
|
0 Percentage of participants
Interval 0.0 to 2.5
|
|
Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2
Pain at the injection site: Grade 4
|
0 Percentage of participants
Interval 0.0 to 2.5
|
0 Percentage of participants
Interval 0.0 to 2.5
|
PRIMARY outcome
Timeframe: From Day 1 to Day 7 after dose 1Population: For maternal participants, safety population included all randomized participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in the SAP.
Systemic events were recorded by participants in an e-diary. Fever was oral temperature \>= 38 degree Celsius (°C) \& categorized as \>=38.0 to 38.4 °C, \>38.4 to 38.9 °C, \>38.9 to 40.0 °C \& \>40.0 °C. Fatigue, headache, chills, new or worsened muscle pain \& new or worsened joint pain were graded mild: did not interfere with activity, moderate: some interference with activity \& severe: prevented daily routine activity. Vomiting was graded mild: 1 to 2 times in 24 hours (h), moderate: \>2 times in 24h \& severe: required intravenous hydration. Diarrhea was graded mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h \& severe: 6 or more loose stools in 24h. For all systemic events except fever, Grade 4= emergency room visit or hospitalization. Grade 4 events were classified by the investigator/medically qualified person. Systemic events reported as AEs in the CRF within 7 days after vaccination were also included in analysis. Exact 95% CI was based on Clopper \& Pearson method.
Outcome measures
| Measure |
Maternal Participants: BNT162b2 30 mcg
n=161 Participants
Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.
|
Maternal Participants: Placebo
n=163 Participants
Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.
|
|---|---|---|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1
Chills: Moderate
|
1.9 Percentage of participants
Interval 0.4 to 5.3
|
0 Percentage of participants
Interval 0.0 to 2.2
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1
Chills: Severe
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0 Percentage of participants
Interval 0.0 to 2.2
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1
Chills: Grade 4
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0 Percentage of participants
Interval 0.0 to 2.2
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1
Vomiting: Mild
|
5.0 Percentage of participants
Interval 2.2 to 9.6
|
6.1 Percentage of participants
Interval 3.0 to 11.0
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1
Vomiting: Moderate
|
0 Percentage of participants
Interval 0.0 to 2.3
|
3.1 Percentage of participants
Interval 1.0 to 7.0
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1
Vomiting: Severe
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0 Percentage of participants
Interval 0.0 to 2.2
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1
Vomiting: Grade 4
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0 Percentage of participants
Interval 0.0 to 2.2
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1
Diarrhea: Mild
|
11.2 Percentage of participants
Interval 6.8 to 17.1
|
7.4 Percentage of participants
Interval 3.9 to 12.5
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1
Diarrhea: Moderate
|
0.6 Percentage of participants
Interval 0.0 to 3.4
|
1.2 Percentage of participants
Interval 0.1 to 4.4
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1
Diarrhea: Severe
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0 Percentage of participants
Interval 0.0 to 2.2
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1
Diarrhea: Grade 4
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0 Percentage of participants
Interval 0.0 to 2.2
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1
New or worsened muscle pain: Mild
|
6.8 Percentage of participants
Interval 3.5 to 11.9
|
6.1 Percentage of participants
Interval 3.0 to 11.0
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1
New or worsened muscle pain: Moderate
|
5.6 Percentage of participants
Interval 2.6 to 10.3
|
5.5 Percentage of participants
Interval 2.6 to 10.2
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1
New or worsened muscle pain: Severe
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0 Percentage of participants
Interval 0.0 to 2.2
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1
New or worsened muscle pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0 Percentage of participants
Interval 0.0 to 2.2
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1
New or worsened joint pain: Mild
|
1.2 Percentage of participants
Interval 0.2 to 4.4
|
2.5 Percentage of participants
Interval 0.7 to 6.2
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1
New or worsened joint pain: Moderate
|
1.9 Percentage of participants
Interval 0.4 to 5.3
|
2.5 Percentage of participants
Interval 0.7 to 6.2
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1
New or worsened joint pain: Severe
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0 Percentage of participants
Interval 0.0 to 2.2
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1
New or worsened joint pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0 Percentage of participants
Interval 0.0 to 2.2
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1
Fever: >=38.0 to 38.4 deg C (100.4 to 101.1 deg Fahrenheit [F])
|
0.6 Percentage of participants
Interval 0.0 to 3.4
|
1.2 Percentage of participants
Interval 0.1 to 4.4
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1
Fever: >38.4 to 38.9 deg C (101.2 to 102.0 deg F)
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0 Percentage of participants
Interval 0.0 to 2.2
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1
Fever: >38.9 to 40.0 deg C (102.1 to 104.0 deg F)
|
0.6 Percentage of participants
Interval 0.0 to 3.4
|
0.6 Percentage of participants
Interval 0.0 to 3.4
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1
Fever: >40 deg C (>104.0 deg F)
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0 Percentage of participants
Interval 0.0 to 2.2
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1
Fatigue/tiredness: Mild
|
26.1 Percentage of participants
Interval 19.5 to 33.6
|
20.9 Percentage of participants
Interval 14.9 to 27.9
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1
Fatigue/tiredness: Moderate
|
23.0 Percentage of participants
Interval 16.7 to 30.3
|
21.5 Percentage of participants
Interval 15.4 to 28.6
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1
Fatigue/tiredness: Severe
|
0.6 Percentage of participants
Interval 0.0 to 3.4
|
0.6 Percentage of participants
Interval 0.0 to 3.4
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1
Fatigue/tiredness: Grade 4
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0 Percentage of participants
Interval 0.0 to 2.2
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1
Headache: Mild
|
20.5 Percentage of participants
Interval 14.5 to 27.6
|
22.1 Percentage of participants
Interval 16.0 to 29.2
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1
Headache: Moderate
|
11.8 Percentage of participants
Interval 7.3 to 17.8
|
12.9 Percentage of participants
Interval 8.2 to 19.0
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1
Headache: Severe
|
1.9 Percentage of participants
Interval 0.4 to 5.3
|
0.6 Percentage of participants
Interval 0.0 to 3.4
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1
Headache: Grade 4
|
0 Percentage of participants
Interval 0.0 to 2.3
|
0 Percentage of participants
Interval 0.0 to 2.2
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1
Chills: Mild
|
5.0 Percentage of participants
Interval 2.2 to 9.6
|
5.5 Percentage of participants
Interval 2.6 to 10.2
|
PRIMARY outcome
Timeframe: From Day 1 to Day 7 after dose 2Population: For maternal participants, safety population included all randomized participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in the SAP.
Systemic events were recorded by participants in an e-diary. Fever was oral temperature \>= 38 °C \& categorized as \>=38.0 to 38.4 °C, \>38.4 to 38.9 °C, \>38.9 to 40.0 °C \& \>40.0 °C. Fatigue, headache, chills, new or worsened muscle pain \& new or worsened joint pain were graded mild: did not interfere with activity, moderate: some interference with activity \& severe: prevented daily routine activity. Vomiting was graded mild: 1 to 2 times in 24 h, moderate: \>2 times in 24 h \& severe: required intravenous hydration. Diarrhea was graded mild: 2 to 3 loose stools in 24 h, moderate: 4 to 5 loose stools in 24 h \& severe: 6 or more loose stools in 24 h. For all systemic events except fever, Grade 4= emergency room visit or hospitalization. Grade 4 events were classified by the investigator/medically qualified person. Systemic events reported as AEs in the CRF within 7 days after vaccination were also included in analysis. Exact 95% CI was based on Clopper \& Pearson method.
Outcome measures
| Measure |
Maternal Participants: BNT162b2 30 mcg
n=148 Participants
Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.
|
Maternal Participants: Placebo
n=146 Participants
Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.
|
|---|---|---|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2
Fever: >=38.0 to 38.4 deg C (100.4 to 101.1 deg F)
|
1.4 Percentage of participants
Interval 0.2 to 4.8
|
0.7 Percentage of participants
Interval 0.0 to 3.8
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2
Fever: >38.4 to 38.9 deg C (101.2 to 102.0 deg F)
|
0.7 Percentage of participants
Interval 0.0 to 3.7
|
0 Percentage of participants
Interval 0.0 to 2.5
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2
Fever: >38.9 to 40.0 deg C (102.1 to 104.0 deg F)
|
0 Percentage of participants
Interval 0.0 to 2.5
|
0 Percentage of participants
Interval 0.0 to 2.5
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2
Fever: >40 deg C (>104.0 deg F)
|
0 Percentage of participants
Interval 0.0 to 2.5
|
0 Percentage of participants
Interval 0.0 to 2.5
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2
Fatigue/tiredness: Mild
|
15.5 Percentage of participants
Interval 10.1 to 22.4
|
15.8 Percentage of participants
Interval 10.3 to 22.7
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2
Fatigue/tiredness: Moderate
|
32.4 Percentage of participants
Interval 25.0 to 40.6
|
18.5 Percentage of participants
Interval 12.6 to 25.8
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2
Fatigue/tiredness: Severe
|
2.0 Percentage of participants
Interval 0.4 to 5.8
|
0 Percentage of participants
Interval 0.0 to 2.5
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2
Fatigue/tiredness: Grade 4
|
0 Percentage of participants
Interval 0.0 to 2.5
|
0 Percentage of participants
Interval 0.0 to 2.5
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2
Headache: Mild
|
25.0 Percentage of participants
Interval 18.3 to 32.8
|
13.7 Percentage of participants
Interval 8.6 to 20.4
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2
Headache: Moderate
|
14.9 Percentage of participants
Interval 9.6 to 21.6
|
10.3 Percentage of participants
Interval 5.9 to 16.4
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2
Headache: Severe
|
1.4 Percentage of participants
Interval 0.2 to 4.8
|
0 Percentage of participants
Interval 0.0 to 2.5
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2
Headache: Grade 4
|
0 Percentage of participants
Interval 0.0 to 2.5
|
0 Percentage of participants
Interval 0.0 to 2.5
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2
Chills: Mild
|
4.7 Percentage of participants
Interval 1.9 to 9.5
|
0.7 Percentage of participants
Interval 0.0 to 3.8
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2
Chills: Moderate
|
7.4 Percentage of participants
Interval 3.8 to 12.9
|
0 Percentage of participants
Interval 0.0 to 2.5
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2
Chills: Severe
|
0.7 Percentage of participants
Interval 0.0 to 3.7
|
0 Percentage of participants
Interval 0.0 to 2.5
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2
Chills: Grade 4
|
0 Percentage of participants
Interval 0.0 to 2.5
|
0 Percentage of participants
Interval 0.0 to 2.5
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2
Vomiting: Mild
|
8.8 Percentage of participants
Interval 4.8 to 14.6
|
2.1 Percentage of participants
Interval 0.4 to 5.9
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2
Vomiting: Moderate
|
0 Percentage of participants
Interval 0.0 to 2.5
|
1.4 Percentage of participants
Interval 0.2 to 4.9
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2
Vomiting: Severe
|
0 Percentage of participants
Interval 0.0 to 2.5
|
0 Percentage of participants
Interval 0.0 to 2.5
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2
Vomiting: Grade 4
|
0 Percentage of participants
Interval 0.0 to 2.5
|
0 Percentage of participants
Interval 0.0 to 2.5
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2
Diarrhea: Mild
|
6.1 Percentage of participants
Interval 2.8 to 11.2
|
4.1 Percentage of participants
Interval 1.5 to 8.7
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2
Diarrhea: Moderate
|
0 Percentage of participants
Interval 0.0 to 2.5
|
1.4 Percentage of participants
Interval 0.2 to 4.9
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2
Diarrhea: Severe
|
0 Percentage of participants
Interval 0.0 to 2.5
|
0 Percentage of participants
Interval 0.0 to 2.5
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2
Diarrhea: Grade 4
|
0 Percentage of participants
Interval 0.0 to 2.5
|
0 Percentage of participants
Interval 0.0 to 2.5
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2
New or worsened muscle pain: Mild
|
13.5 Percentage of participants
Interval 8.5 to 20.1
|
4.8 Percentage of participants
Interval 1.9 to 9.6
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2
New or worsened muscle pain: Moderate
|
12.8 Percentage of participants
Interval 7.9 to 19.3
|
2.1 Percentage of participants
Interval 0.4 to 5.9
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2
New or worsened muscle pain: Severe
|
0.7 Percentage of participants
Interval 0.0 to 3.7
|
0 Percentage of participants
Interval 0.0 to 2.5
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2
New or worsened muscle pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 2.5
|
0 Percentage of participants
Interval 0.0 to 2.5
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2
New or worsened joint pain: Mild
|
7.4 Percentage of participants
Interval 3.8 to 12.9
|
4.8 Percentage of participants
Interval 1.9 to 9.6
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2
New or worsened joint pain: Moderate
|
6.1 Percentage of participants
Interval 2.8 to 11.2
|
1.4 Percentage of participants
Interval 0.2 to 4.9
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2
New or worsened joint pain: Severe
|
0 Percentage of participants
Interval 0.0 to 2.5
|
0 Percentage of participants
Interval 0.0 to 2.5
|
|
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2
New or worsened joint pain: Grade 4
|
0 Percentage of participants
Interval 0.0 to 2.5
|
0 Percentage of participants
Interval 0.0 to 2.5
|
PRIMARY outcome
Timeframe: From dose 1 on Day 1 through 1 month after dose 2 (approximately 2 months)Population: For maternal participants, safety population included all randomized participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in the SAP.
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
Outcome measures
| Measure |
Maternal Participants: BNT162b2 30 mcg
n=161 Participants
Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.
|
Maternal Participants: Placebo
n=163 Participants
Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.
|
|---|---|---|
|
Percentage of Maternal Participants With Adverse Events (AEs) From Dose 1 Through 1 Month After Dose 2 - Blinded Follow-up Period
|
23.6 Percentage of participants
Interval 17.3 to 30.9
|
22.7 Percentage of participants
Interval 16.5 to 29.9
|
PRIMARY outcome
Timeframe: From dose 1 on Day 1 through 1 month after delivery (up to 22 weeks)Population: For maternal participants, safety population included all randomized participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in the SAP.
An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
Maternal Participants: BNT162b2 30 mcg
n=161 Participants
Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.
|
Maternal Participants: Placebo
n=163 Participants
Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.
|
|---|---|---|
|
Percentage of Maternal Participants Reporting Serious Adverse Events (SAEs) From Dose 1 Through 1 Month After Delivery - Blinded Follow-up Period
|
13.0 Percentage of participants
Interval 8.3 to 19.2
|
14.1 Percentage of participants
Interval 9.2 to 20.4
|
PRIMARY outcome
Timeframe: 1 Month after Dose 2Population: Evaluable immunogenicity population without evidence of SARS-CoV2 infection up to 1 month after Dose 2 was analyzed. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in the SAP.
GMR of SARS-CoV-2 neutralizing titers in pregnant women to those in nonpregnant women from study C4591001 (NCT04368728) for evaluable immunogenicity population without evidence of prior SARS-CoV-2 infection up to 1 month after Dose 2 was reported in this outcome measure. Geometric mean titer (GMT) and 2-sided 95% CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on student t distribution) and was reported in descriptive section. GMR was reported in statistical analysis section of this outcome measure. Evaluable immunogenicity population included all participants who were eligible and randomized, received 2 doses of vaccine to which they were randomized, with Dose 2 received within predefined window (19-42 days, inclusive, after Dose 1); had at least 1 valid immunogenicity result within an appropriate window 1 month after Dose 2 (28-42 days, inclusive, after Dose 2); and had no other important protocol deviations as determined by the clinician.
Outcome measures
| Measure |
Maternal Participants: BNT162b2 30 mcg
n=58 Participants
Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.
|
Maternal Participants: Placebo
n=107 Participants
Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.
|
|---|---|---|
|
Geometric Mean Ratio (GMR) of the SARS-CoV-2 Neutralizing Titers in Pregnant Women to Those in Nonpregnant Women From Study C4591001 (NCT04368728) for Evaluable Immunogenicity Population Without Evidence of Prior SARS-CoV-2 Infection
|
1109.2 Titer
Interval 849.2 to 1448.9
|
1663.7 Titer
Interval 1411.5 to 1960.8
|
PRIMARY outcome
Timeframe: 1 Month after Dose 2Population: Evaluable immunogenicity population was analyzed. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in the SAP.
GMR of SARS-CoV-2 neutralizing titers in pregnant women to those in nonpregnant women from study C4591001 (NCT04368728) for evaluable immunogenicity population with and without evidence of prior SARS-CoV-2 infection was reported in this outcome measure. GMT and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the student t distribution) and was reported in the descriptive section. GMR was reported in the statistical analysis section. Evaluable immunogenicity population included all participants who were eligible and randomized, received 2 doses of the vaccine to which they were randomized, with Dose 2 received within the predefined window (19-42 days, inclusive, after Dose 1); had at least 1 valid immunogenicity result within an appropriate window 1 month after Dose 2 (28-42 days, inclusive, after Dose 2); and had no other important protocol deviations as determined by the clinician.
Outcome measures
| Measure |
Maternal Participants: BNT162b2 30 mcg
n=100 Participants
Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.
|
Maternal Participants: Placebo
n=114 Participants
Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.
|
|---|---|---|
|
GMR of SARS-CoV-2 Neutralizing Titers in Pregnant Women to Those in Nonpregnant Women From Study C4591001 (NCT04368728) for Evaluable Immunogenicity Population With and Without Evidence of Prior SARS-CoV-2 Infection
|
2198.7 Titer
Interval 1618.5 to 2987.0
|
1732.0 Titer
Interval 1469.4 to 2041.5
|
SECONDARY outcome
Timeframe: From 7 days after Dose 2 up to 1 month after delivery (Surveillance time [100 person-year]: BNT162b2- 0.155, Placebo- 0.149)Population: Evaluable efficacy population included all eligible randomized participants who received all vaccinations as randomized, with Dose 2 received within predefined window (within 19-42 days after Dose 1) and had no other important protocol deviations as determined by clinician on or before 7 days after Dose 2. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in SAP.
COVID-19 incidence per 100 person-years of blinded follow-up in evaluable maternal participants without evidence of prior SARS-CoV-2 infection prior to 7 days after receipt of Dose 2 was reported in this outcome measure.
Outcome measures
| Measure |
Maternal Participants: BNT162b2 30 mcg
n=86 Participants
Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.
|
Maternal Participants: Placebo
n=89 Participants
Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.
|
|---|---|---|
|
COVID-19 Incidence Per 100 Person-Years of Blinded Follow up in Evaluable Maternal Participants Without Evidence of Prior SARS-CoV-2 Infection
|
12.903 Events per 100 person-years
|
13.423 Events per 100 person-years
|
SECONDARY outcome
Timeframe: From 7 days after Dose 2 up to 1 month after delivery (Surveillance time [100 person-year]: BNT162b2- 0.270, Placebo- 0.263)Population: Evaluable efficacy population included all eligible randomized participants who received all vaccinations as randomized, with Dose 2 received within predefined window (within 19-42 days after Dose 1) and had no other important protocol deviations as determined by clinician on or before 7 days after Dose 2. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in SAP.
COVID-19 incidence per 100 person-years of blinded follow-up in evaluable maternal participants with or without evidence of prior SARS-CoV-2 infection was reported in this outcome measure.
Outcome measures
| Measure |
Maternal Participants: BNT162b2 30 mcg
n=145 Participants
Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.
|
Maternal Participants: Placebo
n=149 Participants
Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.
|
|---|---|---|
|
COVID-19 Incidence Per 100 Person-Years of Blinded Follow up in Evaluable Maternal Participants With or Without Evidence of Prior SARS-CoV-2 Infection
|
7.407 Events per 100 person-years
|
11.407 Events per 100 person-years
|
SECONDARY outcome
Timeframe: Up to 1 month after delivery (Surveillance time [100 person-year]: BNT162b2- 0.099, Placebo- 0.147)Population: Evaluable efficacy population included all eligible randomized participants who received all vaccinations as randomized, with Dose 2 received within predefined window (within 19-42 days after Dose 1) and had no other important protocol deviations as determined by clinician on or before 7 days after Dose 2. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in SAP.
Incidence of asymptomatic infection of SARS-CoV-2 through 1 month after delivery in evaluable maternal participants without evidence of prior SARS-CoV-2 infection prior to the first post-dose 2 N-binding test was reported in this outcome measure.
Outcome measures
| Measure |
Maternal Participants: BNT162b2 30 mcg
n=84 Participants
Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.
|
Maternal Participants: Placebo
n=89 Participants
Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.
|
|---|---|---|
|
Incidence of Asymptomatic Infection of SARS-CoV-2 Through 1 Month After Delivery in Evaluable Maternal Participants Without Evidence of Prior SARS-CoV-2 Infection
|
40.404 Events per 100 person-years
|
68.027 Events per 100 person-years
|
SECONDARY outcome
Timeframe: Baseline (before Dose 1), 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after deliveryPopulation: Evaluable immunogenicity population was analyzed. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for the specified rows. HIV positive participants were excluded from analysis as pre-specified in the SAP.
GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ. GMCs of full-length S-binding IgG levels in evaluable maternal participants at baseline, 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery was reported in this outcome measure. Evaluable immunogenicity population included all participants who were eligible and randomized, received 2 doses of the vaccine to which they were randomized, with Dose 2 received within the predefined window (19-42 days, inclusive, after Dose 1); had at least 1 valid immunogenicity result within an appropriate window 1 month after Dose 2 (28-42 days, inclusive, after Dose 2); and had no other important protocol deviations as determined by the clinician.
Outcome measures
| Measure |
Maternal Participants: BNT162b2 30 mcg
n=65 Participants
Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.
|
Maternal Participants: Placebo
n=59 Participants
Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.
|
|---|---|---|
|
Geometric Mean Concentration (GMCs) of Full-Length S-Binding Immunoglobulin G (IgG) Levels in Evaluable Maternal Participants
Before Dose 1
|
2.4 Units/milliliter (U/mL)
Interval 1.6 to 3.7
|
2.0 Units/milliliter (U/mL)
Interval 1.4 to 2.8
|
|
Geometric Mean Concentration (GMCs) of Full-Length S-Binding Immunoglobulin G (IgG) Levels in Evaluable Maternal Participants
2 weeks after Dose 2
|
7802.0 Units/milliliter (U/mL)
Interval 6273.3 to 9703.2
|
1.8 Units/milliliter (U/mL)
Interval 1.1 to 3.1
|
|
Geometric Mean Concentration (GMCs) of Full-Length S-Binding Immunoglobulin G (IgG) Levels in Evaluable Maternal Participants
1 month after Dose 2
|
4281.0 Units/milliliter (U/mL)
Interval 3234.7 to 5665.7
|
1.8 Units/milliliter (U/mL)
Interval 1.1 to 2.9
|
|
Geometric Mean Concentration (GMCs) of Full-Length S-Binding Immunoglobulin G (IgG) Levels in Evaluable Maternal Participants
At delivery
|
2747.6 Units/milliliter (U/mL)
Interval 2144.7 to 3520.0
|
1.7 Units/milliliter (U/mL)
Interval 1.0 to 3.0
|
|
Geometric Mean Concentration (GMCs) of Full-Length S-Binding Immunoglobulin G (IgG) Levels in Evaluable Maternal Participants
6 months after delivery
|
1639.4 Units/milliliter (U/mL)
Interval 780.1 to 3445.4
|
—
|
SECONDARY outcome
Timeframe: Baseline (before Dose 1), 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after deliveryPopulation: Evaluable immunogenicity population was analyzed. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for the specified rows. HIV positive participants were excluded from analysis as pre-specified in the SAP.
GMTs, and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ. GMTs of SARS-CoV-2 neutralizing titers in evaluable maternal participants at baseline, 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery was reported in this outcome measure. Evaluable immunogenicity population included all participants who were eligible and randomized, received 2 doses of the vaccine to which they were randomized, with Dose 2 received within the predefined window (19-42 days, inclusive, after Dose 1); had at least 1 valid immunogenicity result within an appropriate window 1 month after Dose 2 (28-42 days, inclusive, after Dose 2); and had no other important protocol deviations as determined by the clinician.
Outcome measures
| Measure |
Maternal Participants: BNT162b2 30 mcg
n=65 Participants
Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.
|
Maternal Participants: Placebo
n=59 Participants
Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.
|
|---|---|---|
|
Geometric Mean Titer (GMTs) of SARS-CoV-2 Neutralizing Titers in Evaluable Maternal Participants
2 weeks after Dose 2
|
1991.8 Titer
Interval 1456.3 to 2724.1
|
45.0 Titer
Interval 42.0 to 48.3
|
|
Geometric Mean Titer (GMTs) of SARS-CoV-2 Neutralizing Titers in Evaluable Maternal Participants
Before Dose 1
|
47.6 Titer
Interval 41.6 to 54.4
|
43.5 Titer
Interval 43.5 to 43.5
|
|
Geometric Mean Titer (GMTs) of SARS-CoV-2 Neutralizing Titers in Evaluable Maternal Participants
1 month after Dose 2
|
1212.6 Titer
Interval 855.2 to 1719.4
|
43.5 Titer
Interval 43.5 to 43.5
|
|
Geometric Mean Titer (GMTs) of SARS-CoV-2 Neutralizing Titers in Evaluable Maternal Participants
At delivery
|
695.7 Titer
Interval 500.6 to 966.8
|
43.5 Titer
Interval 43.5 to 43.5
|
|
Geometric Mean Titer (GMTs) of SARS-CoV-2 Neutralizing Titers in Evaluable Maternal Participants
6 months after delivery
|
465.4 Titer
Interval 168.6 to 1284.5
|
—
|
SECONDARY outcome
Timeframe: From before dose 1 up to 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after deliveryPopulation: Evaluable immunogenicity population was analyzed. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for the specified rows. HIV positive participants were excluded from analysis as pre-specified in the SAP.
GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ. GMFR from before vaccination to each subsequent time point after vaccination for full-length S-binding IgG levels in evaluable maternal participants at 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery was reported in this outcome measure. Evaluable immunogenicity population included all participants who were eligible and randomized, received 2 doses of the vaccine to which they were randomized, with Dose 2 received within the predefined window (19-42 days, inclusive, after Dose 1); had at least 1 valid immunogenicity result within an appropriate window 1 month after Dose 2 (28-42 days, inclusive, after Dose 2); and had no other important protocol deviations as determined by the clinician.
Outcome measures
| Measure |
Maternal Participants: BNT162b2 30 mcg
n=58 Participants
Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.
|
Maternal Participants: Placebo
n=54 Participants
Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.
|
|---|---|---|
|
Geometric Mean Fold Rise (GMFR) From Before Vaccination to Each Subsequent Time Point After Vaccination for Full-Length S-Binding IgG Levels in Evaluable Maternal Participants
2 weeks after Dose 2
|
3618.7 Fold rise
Interval 2489.1 to 5260.7
|
0.9 Fold rise
Interval 0.8 to 1.1
|
|
Geometric Mean Fold Rise (GMFR) From Before Vaccination to Each Subsequent Time Point After Vaccination for Full-Length S-Binding IgG Levels in Evaluable Maternal Participants
1 month after Dose 2
|
2276.4 Fold rise
Interval 1545.5 to 3352.9
|
0.9 Fold rise
Interval 0.8 to 1.1
|
|
Geometric Mean Fold Rise (GMFR) From Before Vaccination to Each Subsequent Time Point After Vaccination for Full-Length S-Binding IgG Levels in Evaluable Maternal Participants
At delivery
|
1377.6 Fold rise
Interval 948.6 to 2000.5
|
0.8 Fold rise
Interval 0.6 to 1.0
|
|
Geometric Mean Fold Rise (GMFR) From Before Vaccination to Each Subsequent Time Point After Vaccination for Full-Length S-Binding IgG Levels in Evaluable Maternal Participants
6 months after delivery
|
650.3 Fold rise
Interval 279.3 to 1514.3
|
—
|
SECONDARY outcome
Timeframe: From before dose 1 up to 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after deliveryPopulation: Evaluable immunogenicity population was analyzed. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for the specified rows. HIV positive participants were excluded from analysis as pre-specified in the SAP.
GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ. GMFR from before vaccination to each subsequent time point after vaccination for SARS-CoV-2 neutralizing titers in evaluable maternal participants at 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery was reported in this outcome measure. Evaluable immunogenicity population included all participants who were eligible and randomized, received 2 doses of the vaccine to which they were randomized, with Dose 2 received within the predefined window (19-42 days, inclusive, after Dose 1); had at least 1 valid immunogenicity result within an appropriate window 1 month after Dose 2 (28-42 days, inclusive, after Dose 2); and had no other important protocol deviations as determined by the clinician.
Outcome measures
| Measure |
Maternal Participants: BNT162b2 30 mcg
n=58 Participants
Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.
|
Maternal Participants: Placebo
n=54 Participants
Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.
|
|---|---|---|
|
Geometric Mean Fold Rise (GMFR) From Before Vaccination to Each Subsequent Time Point After Vaccination for SARS-CoV-2 Neutralizing Titers in Evaluable Maternal Participants
2 weeks after Dose 2
|
43.7 Fold rise
Interval 33.9 to 56.4
|
1.0 Fold rise
Interval 1.0 to 1.1
|
|
Geometric Mean Fold Rise (GMFR) From Before Vaccination to Each Subsequent Time Point After Vaccination for SARS-CoV-2 Neutralizing Titers in Evaluable Maternal Participants
1 month after Dose 2
|
25.3 Fold rise
Interval 18.9 to 33.9
|
1.0 Fold rise
Interval 1.0 to 1.0
|
|
Geometric Mean Fold Rise (GMFR) From Before Vaccination to Each Subsequent Time Point After Vaccination for SARS-CoV-2 Neutralizing Titers in Evaluable Maternal Participants
At delivery
|
15.6 Fold rise
Interval 12.1 to 20.1
|
1.0 Fold rise
Interval 1.0 to 1.0
|
|
Geometric Mean Fold Rise (GMFR) From Before Vaccination to Each Subsequent Time Point After Vaccination for SARS-CoV-2 Neutralizing Titers in Evaluable Maternal Participants
6 months after delivery
|
11.3 Fold rise
Interval 5.0 to 25.4
|
—
|
SECONDARY outcome
Timeframe: At birthPopulation: Safety population for infant participants included all infant participants born to maternal participants who received at least 1 dose of the study intervention. As this outcome measure was measured at birth, HIV positive infant participants were included in this outcome measure.
Percentage of infant participants reporting specific birth outcomes (normal, congenital malformation/anomaly, other neonatal problems) were reported in this outcome measure.
Outcome measures
| Measure |
Maternal Participants: BNT162b2 30 mcg
n=167 Participants
Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.
|
Maternal Participants: Placebo
n=168 Participants
Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.
|
|---|---|---|
|
Percentage of Infant Participants Reporting Specific Birth Outcomes
Normal
|
91.6 Percentage of participants
Interval 86.3 to 95.3
|
89.3 Percentage of participants
Interval 83.6 to 93.5
|
|
Percentage of Infant Participants Reporting Specific Birth Outcomes
Congenital malformation/anomaly
|
6.0 Percentage of participants
Interval 2.9 to 10.7
|
3.6 Percentage of participants
Interval 1.3 to 7.6
|
|
Percentage of Infant Participants Reporting Specific Birth Outcomes
Other neonatal problem
|
1.8 Percentage of participants
Interval 0.4 to 5.2
|
6.5 Percentage of participants
Interval 3.3 to 11.4
|
SECONDARY outcome
Timeframe: From birth through 1 month of agePopulation: Safety population for infant participants included all infant participants born to maternal participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in the SAP.
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
Maternal Participants: BNT162b2 30 mcg
n=156 Participants
Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.
|
Maternal Participants: Placebo
n=159 Participants
Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.
|
|---|---|---|
|
Percentage of Infant Participants Reporting Adverse Events From Birth Through 1 Month of Age
|
35.3 Percentage of participants
Interval 27.8 to 43.3
|
37.1 Percentage of participants
Interval 29.6 to 45.1
|
SECONDARY outcome
Timeframe: From birth through 6 months of agePopulation: Safety population for infant participants included all infant participants born to maternal participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in the SAP.
An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
Maternal Participants: BNT162b2 30 mcg
n=156 Participants
Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.
|
Maternal Participants: Placebo
n=159 Participants
Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.
|
|---|---|---|
|
Percentage of Infant Participants Reporting Serious Adverse Events (SAE) From Birth Through 6 Months of Age
|
13.5 Percentage of participants
Interval 8.5 to 19.8
|
15.1 Percentage of participants
Interval 9.9 to 21.6
|
SECONDARY outcome
Timeframe: From birth through 6 months of agePopulation: Safety population for infant participants included all infant participants born to maternal participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in the SAP.
Percentage of infant participants who reported AESI including major congenital anomalies and developmental delay from birth through 6 months of age were reported in this outcome measure. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Outcome measures
| Measure |
Maternal Participants: BNT162b2 30 mcg
n=156 Participants
Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.
|
Maternal Participants: Placebo
n=159 Participants
Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.
|
|---|---|---|
|
Percentage of Infant Participants Reporting Adverse Event of Special Interest (AESI) From Birth Through 6 Months of Age
|
5.1 Percentage of participants
Interval 2.2 to 9.9
|
1.3 Percentage of participants
Interval 0.2 to 4.5
|
SECONDARY outcome
Timeframe: At birth and 6 months of agePopulation: All infant participants born to evaluable immunogenicity maternal participants and had no important protocol deviations as determined by the clinician. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for the specified rows. HIV positive participants were excluded from analysis as pre-specified in the SAP.
GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ. GMCs of full-length S-binding IgG levels at birth and 6 months of age in infant participants born to evaluable maternal participants was reported in this outcome measure.
Outcome measures
| Measure |
Maternal Participants: BNT162b2 30 mcg
n=91 Participants
Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.
|
Maternal Participants: Placebo
n=92 Participants
Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.
|
|---|---|---|
|
GMCs of Full-Length S-Binding IgG Levels at Birth and 6 Months of Age in Infant Participants Born to Evaluable Maternal Participants
At Birth
|
5576.4 Units/milliliter (U/mL)
Interval 4246.2 to 7323.2
|
19.4 Units/milliliter (U/mL)
Interval 10.2 to 37.0
|
|
GMCs of Full-Length S-Binding IgG Levels at Birth and 6 Months of Age in Infant Participants Born to Evaluable Maternal Participants
6 months of age
|
311.1 Units/milliliter (U/mL)
Interval 235.8 to 410.5
|
22.0 Units/milliliter (U/mL)
Interval 11.4 to 42.7
|
SECONDARY outcome
Timeframe: From birth to 6 months of agePopulation: All infant participants born to evaluable immunogenicity maternal participants and had no important protocol deviations as determined by the clinician. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in the SAP.
GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ. GMFR of full-length S-binding IgG levels from birth to 6 months of age in infant participants born to evaluable maternal participants was reported in this outcome measure.
Outcome measures
| Measure |
Maternal Participants: BNT162b2 30 mcg
n=75 Participants
Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.
|
Maternal Participants: Placebo
n=65 Participants
Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.
|
|---|---|---|
|
GMFR of Full-Length S-Binding IgG Levels From Birth to 6 Months of Age in Infant Participants Born to Evaluable Maternal Participants
|
0.1 Fold rise
Interval 0.0 to 0.1
|
0.6 Fold rise
Interval 0.3 to 1.3
|
Adverse Events
Maternal Participants: BNT162b2 30 mcg (Blinded Phase)
Maternal Participants: Placebo (Blinded Phase)
Maternal Participants: Placebo Then BNT162b2 (Unblinded Phase)
Infant Participants: BNT162b2 30 mcg
Infant Participants: Placebo
HIV Positive Maternal Participants: BNT162b2 30 mcg (Blinded Phase)
HIV Positive Maternal Participants: Placebo (Blinded Phase)
HIV Positive Maternal Participants: Placebo Then BNT162b2 (Unblinded Phase)
HIV Positive Infant Participants: BNT162b2 30 mcg
HIV Positive Infant Participants: Placebo
Serious adverse events
| Measure |
Maternal Participants: BNT162b2 30 mcg (Blinded Phase)
n=161 participants at risk
Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery. HIV positive maternal participants were excluded.
|
Maternal Participants: Placebo (Blinded Phase)
n=163 participants at risk
Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. HIV positive maternal participants were excluded.
|
Maternal Participants: Placebo Then BNT162b2 (Unblinded Phase)
n=144 participants at risk
Participants who originally received 2 doses of blinded placebo were administered 2 doses of 30 mcg BNT162b2 vaccine as intramuscular injection separated by 21 days after unblinding at 1 month post-delivery. Participants were followed-up until 1 month after last vaccination. HIV positive maternal participants were excluded.
|
Infant Participants: BNT162b2 30 mcg
n=156 participants at risk
Infant participants who were born to maternal participants vaccinated with BNT162b2 30 mcg during pregnancy were included. Infant participants were followed up to 6 months of age. HIV positive infant participants born to HIV positive maternal participants were excluded.
|
Infant Participants: Placebo
n=159 participants at risk
Infant participants who were born to maternal participants vaccinated with placebo during pregnancy were included. Infant participants were followed up to 6 months of age. HIV positive infant participants born to HIV positive maternal participants were excluded.
|
HIV Positive Maternal Participants: BNT162b2 30 mcg (Blinded Phase)
n=12 participants at risk
Maternal participants who were HIV positive received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.
|
HIV Positive Maternal Participants: Placebo (Blinded Phase)
n=10 participants at risk
Maternal participants who were HIV positive received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.
|
HIV Positive Maternal Participants: Placebo Then BNT162b2 (Unblinded Phase)
n=8 participants at risk
HIV positive maternal participants who originally received 2 doses of blinded placebo were administered 2 doses of 30 mcg BNT162b2 vaccine as intramuscular injection separated by 21 days after unblinding at 1 month post-delivery. Participants were followed-up until 1 month after last vaccination.
|
HIV Positive Infant Participants: BNT162b2 30 mcg
n=11 participants at risk
Infant participants who were born to HIV positive maternal participants vaccinated with BNT162b2 30 mcg during pregnancy were included. Infant participants were followed up to 6 months of age.
|
HIV Positive Infant Participants: Placebo
n=9 participants at risk
Infant participants who were born to HIV positive maternal participants vaccinated with placebo during pregnancy were included. Infant participants were followed up to 6 months of age.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Bradycardia fetal
|
0.62%
1/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Cardiac disorders
Non reassuring fetal heart rate pattern
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
1.2%
2/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.62%
1/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Gastrointestinal disorders
Allergic colitis
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.64%
1/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Gastrointestinal disorders
Allergic gastroenteritis
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.64%
1/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.63%
1/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.63%
1/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Gastrointestinal disorders
Meconium plug syndrome
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.63%
1/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.63%
1/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.61%
1/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia neonatal
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.63%
1/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Infections and infestations
Endometritis
|
0.62%
1/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.62%
1/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.61%
1/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
9.1%
1/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Infections and infestations
Pyelonephritis
|
0.62%
1/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.64%
1/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.61%
1/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
11.1%
1/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
1.3%
2/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.63%
1/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Infections and infestations
Neonatal pneumonia
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.64%
1/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.63%
1/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
11.1%
1/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.63%
1/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.64%
1/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Infections and infestations
Sepsis
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.63%
1/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Infections and infestations
Sepsis neonatal
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
1.3%
2/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Injury, poisoning and procedural complications
Injury to brachial plexus due to birth trauma
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.63%
1/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Injury, poisoning and procedural complications
Traumatic intracranial hemorrhage
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.63%
1/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Injury, poisoning and procedural complications
Urinary tract procedural complication
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.61%
1/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Investigations
Fetal heart rate abnormal
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.61%
1/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Investigations
Cardiac murmur
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.64%
1/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Investigations
Ultrasound fetal abnormal
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.61%
1/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.62%
1/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Pregnancy, puerperium and perinatal conditions
Arrested labor
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.61%
1/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Pregnancy, puerperium and perinatal conditions
Breech presentation
|
0.62%
1/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Pregnancy, puerperium and perinatal conditions
Cephalo-pelvic disproportion
|
0.62%
1/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
1.8%
3/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
10.0%
1/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Pregnancy, puerperium and perinatal conditions
Failed induction of labor
|
0.62%
1/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Pregnancy, puerperium and perinatal conditions
Fetal distress syndrome
|
1.9%
3/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
1.2%
2/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
8.3%
1/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
10.0%
1/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Pregnancy, puerperium and perinatal conditions
Fetal growth restriction
|
0.62%
1/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Pregnancy, puerperium and perinatal conditions
Fetal hypokinesia
|
0.62%
1/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.61%
1/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
10.0%
1/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Pregnancy, puerperium and perinatal conditions
Gestational hypertension
|
0.62%
1/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.61%
1/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Pregnancy, puerperium and perinatal conditions
Hemorrhage in pregnancy
|
0.62%
1/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Pregnancy, puerperium and perinatal conditions
Meconium in amniotic fluid
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.61%
1/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Pregnancy, puerperium and perinatal conditions
Meconium stain
|
0.62%
1/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Pregnancy, puerperium and perinatal conditions
Omphalorrhexis
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.61%
1/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Pregnancy, puerperium and perinatal conditions
Placental insufficiency
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.61%
1/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Pregnancy, puerperium and perinatal conditions
Postpartum hemorrhage
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
1.2%
2/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
8.3%
1/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
|
2.5%
4/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
1.2%
2/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Pregnancy, puerperium and perinatal conditions
Premature separation of placenta
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
1.8%
3/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
8.3%
1/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Pregnancy, puerperium and perinatal conditions
Preterm premature rupture of membranes
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.61%
1/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Pregnancy, puerperium and perinatal conditions
Prolonged rupture of membranes
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.61%
1/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Pregnancy, puerperium and perinatal conditions
Retained placenta or membranes
|
0.62%
1/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Pregnancy, puerperium and perinatal conditions
Caput succedaneum
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.63%
1/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Pregnancy, puerperium and perinatal conditions
Jaundice neonatal
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
4.5%
7/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
2.5%
4/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Pregnancy, puerperium and perinatal conditions
Low birth weight baby
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.64%
1/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Pregnancy, puerperium and perinatal conditions
Premature baby
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.63%
1/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Pregnancy, puerperium and perinatal conditions
Small for dates baby
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.64%
1/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Pregnancy, puerperium and perinatal conditions
Weight decrease neonatal
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.63%
1/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Reproductive system and breast disorders
Uterine disorder
|
1.2%
2/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.62%
1/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Vascular disorders
Deep vein thrombosis
|
0.62%
1/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Vascular disorders
Hypoperfusion
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.63%
1/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Vascular disorders
Hypotension
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.63%
1/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Vascular disorders
Shock
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.63%
1/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Vascular disorders
Subgaleal hemorrhage
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.63%
1/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.63%
1/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.63%
1/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Congenital, familial and genetic disorders
Ankyloglossia congenital
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
1.3%
2/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
1.9%
3/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.63%
1/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Congenital, familial and genetic disorders
Congenital rubella syndrome
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.64%
1/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Congenital, familial and genetic disorders
Congenital skin dimples
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.63%
1/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Congenital, familial and genetic disorders
DiGeorge's syndrome
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.64%
1/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Congenital, familial and genetic disorders
Microcephaly
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.64%
1/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Congenital, familial and genetic disorders
Mucopolysaccharidosis
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.64%
1/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Congenital, familial and genetic disorders
Patent ductus arteriosus
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.63%
1/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Congenital, familial and genetic disorders
Polydactyly
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.64%
1/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Congenital, familial and genetic disorders
Syndactyly
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.64%
1/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Congenital, familial and genetic disorders
Trisomy 21
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.64%
1/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Congenital, familial and genetic disorders
Ventricular septal defect
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.63%
1/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Metabolism and nutrition disorders
Hypoglycemia neonatal
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.63%
1/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.63%
1/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Nervous system disorders
Coma
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.63%
1/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Nervous system disorders
Encephalopathy neonatal
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.63%
1/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Nervous system disorders
Hypoxic-ischemic encephalopathy
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.63%
1/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.64%
1/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Nervous system disorders
Seizure
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.63%
1/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.63%
1/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Renal and urinary disorders
Vesicoureteric reflux
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.64%
1/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.63%
1/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Meconium aspiration syndrome
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
1.3%
2/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal pneumothorax
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.63%
1/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory distress
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
1.3%
2/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory distress syndrome
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.63%
1/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory failure
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.63%
1/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.63%
1/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.63%
1/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.63%
1/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.63%
1/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Pregnancy, puerperium and perinatal conditions
Failed trial of labor
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
10.0%
1/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Pregnancy, puerperium and perinatal conditions
Fetal death
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
8.3%
1/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
8.3%
1/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
11.1%
1/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
11.1%
1/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Nervous system disorders
Superior sagittal sinus thrombosis
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
11.1%
1/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
Other adverse events
| Measure |
Maternal Participants: BNT162b2 30 mcg (Blinded Phase)
n=161 participants at risk
Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery. HIV positive maternal participants were excluded.
|
Maternal Participants: Placebo (Blinded Phase)
n=163 participants at risk
Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. HIV positive maternal participants were excluded.
|
Maternal Participants: Placebo Then BNT162b2 (Unblinded Phase)
n=144 participants at risk
Participants who originally received 2 doses of blinded placebo were administered 2 doses of 30 mcg BNT162b2 vaccine as intramuscular injection separated by 21 days after unblinding at 1 month post-delivery. Participants were followed-up until 1 month after last vaccination. HIV positive maternal participants were excluded.
|
Infant Participants: BNT162b2 30 mcg
n=156 participants at risk
Infant participants who were born to maternal participants vaccinated with BNT162b2 30 mcg during pregnancy were included. Infant participants were followed up to 6 months of age. HIV positive infant participants born to HIV positive maternal participants were excluded.
|
Infant Participants: Placebo
n=159 participants at risk
Infant participants who were born to maternal participants vaccinated with placebo during pregnancy were included. Infant participants were followed up to 6 months of age. HIV positive infant participants born to HIV positive maternal participants were excluded.
|
HIV Positive Maternal Participants: BNT162b2 30 mcg (Blinded Phase)
n=12 participants at risk
Maternal participants who were HIV positive received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.
|
HIV Positive Maternal Participants: Placebo (Blinded Phase)
n=10 participants at risk
Maternal participants who were HIV positive received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase.
|
HIV Positive Maternal Participants: Placebo Then BNT162b2 (Unblinded Phase)
n=8 participants at risk
HIV positive maternal participants who originally received 2 doses of blinded placebo were administered 2 doses of 30 mcg BNT162b2 vaccine as intramuscular injection separated by 21 days after unblinding at 1 month post-delivery. Participants were followed-up until 1 month after last vaccination.
|
HIV Positive Infant Participants: BNT162b2 30 mcg
n=11 participants at risk
Infant participants who were born to HIV positive maternal participants vaccinated with BNT162b2 30 mcg during pregnancy were included. Infant participants were followed up to 6 months of age.
|
HIV Positive Infant Participants: Placebo
n=9 participants at risk
Infant participants who were born to HIV positive maternal participants vaccinated with placebo during pregnancy were included. Infant participants were followed up to 6 months of age.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.5%
4/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
1.2%
2/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
10.0%
1/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Cardiac disorders
Tachycardia
|
1.2%
2/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.9%
3/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
1.8%
3/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
1.2%
2/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Gastrointestinal disorders
Diarrhea (DIARRHEA)
|
14.9%
24/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
12.9%
21/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
25.0%
3/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
30.0%
3/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.62%
1/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
1.2%
2/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.62%
1/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
1.2%
2/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Gastrointestinal disorders
Vomiting (VOMITING)
|
11.2%
18/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
9.8%
16/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
25.0%
3/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
10.0%
1/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
General disorders
Chills (CHILLS)
|
17.4%
28/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
6.1%
10/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
1.4%
2/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
8.3%
1/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
10.0%
1/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
General disorders
Erythema (REDNESS)
|
6.8%
11/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.61%
1/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
General disorders
Fatigue
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
1.2%
2/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
2.1%
3/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
General disorders
Fatigue (FATIGUE)
|
62.7%
101/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
50.3%
82/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
66.7%
8/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
80.0%
8/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
General disorders
Injection site pain (PAIN AT INJECTION SITE)
|
85.7%
138/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
18.4%
30/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
9.0%
13/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
100.0%
12/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
40.0%
4/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
General disorders
Pyrexia (FEVER)
|
3.7%
6/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
2.5%
4/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
10.0%
1/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
General disorders
Swelling (SWELLING)
|
10.6%
17/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.61%
1/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
8.3%
1/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Infections and infestations
Amniotic cavity infection
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
1.2%
2/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Infections and infestations
Urinary tract infection
|
2.5%
4/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.61%
1/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
8.3%
1/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
1.2%
2/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Investigations
Streptococcus test positive
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
1.2%
2/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (NEW OR WORSENED JOINT PAIN)
|
13.7%
22/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
8.0%
13/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
8.3%
1/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
50.0%
5/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.2%
2/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Musculoskeletal and connective tissue disorders
Myalgia (NEW OR WORSENED MUSCLE PAIN)
|
32.9%
53/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
16.0%
26/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
41.7%
5/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
30.0%
3/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Nervous system disorders
Headache
|
1.2%
2/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
1.2%
2/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
4.9%
7/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
12.5%
1/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Nervous system disorders
Headache (HEADACHE)
|
52.8%
85/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
44.2%
72/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
58.3%
7/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
70.0%
7/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Pregnancy, puerperium and perinatal conditions
Abnormal labor
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
1.2%
2/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Pregnancy, puerperium and perinatal conditions
Fetal hypokinesia
|
0.62%
1/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
1.2%
2/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Pregnancy, puerperium and perinatal conditions
Gestational diabetes
|
0.62%
1/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
1.2%
2/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Pregnancy, puerperium and perinatal conditions
Gestational hypertension
|
1.2%
2/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Pregnancy, puerperium and perinatal conditions
Oligohydramnios
|
0.62%
1/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
1.2%
2/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
|
1.2%
2/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Pregnancy, puerperium and perinatal conditions
Premature delivery
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
1.2%
2/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Pregnancy, puerperium and perinatal conditions
Uterine contractions during pregnancy
|
1.2%
2/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.62%
1/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
1.2%
2/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Surgical and medical procedures
Episiotomy
|
1.9%
3/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
General disorders
Injection site erythema
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
2.1%
3/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
General disorders
Pain
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
2.1%
3/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
General disorders
Pyrexia
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
3.5%
5/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Infections and infestations
COVID-19
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
1.4%
2/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
1.4%
2/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
2.8%
4/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Congenital, familial and genetic disorders
Ankyloglossia congenital
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.64%
1/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
1.3%
2/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Congenital, familial and genetic disorders
Congenital naevus
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
1.9%
3/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.63%
1/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
1.3%
2/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
General disorders
Hypothermia
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.64%
1/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
1.3%
2/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Hepatobiliary disorders
Hyperbilirubinemia neonatal
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.64%
1/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
2.5%
4/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Investigations
Apgar score low
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
2.6%
4/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
1.3%
2/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Investigations
Cardiac murmur
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
1.3%
2/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
1.3%
2/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Metabolism and nutrition disorders
Hypoglycemia neonatal
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
1.3%
2/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Nervous system disorders
Hypotonia
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
1.3%
2/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.63%
1/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Pregnancy, puerperium and perinatal conditions
Caput succedaneum
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
1.9%
3/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
1.9%
3/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Pregnancy, puerperium and perinatal conditions
Jaundice neonatal
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
7.7%
12/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
8.2%
13/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
11.1%
1/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Pregnancy, puerperium and perinatal conditions
Large for dates baby
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
1.3%
2/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Pregnancy, puerperium and perinatal conditions
Low birth weight baby
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
1.3%
2/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.63%
1/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Pregnancy, puerperium and perinatal conditions
Small for dates baby
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.64%
1/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
2.5%
4/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
9.1%
1/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Pregnancy, puerperium and perinatal conditions
Umbilical cord around neck
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
3.1%
5/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
10.0%
1/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Infections and infestations
Body tinea
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
10.0%
1/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Renal and urinary disorders
Leukocyturia
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
10.0%
1/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
8.3%
1/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
10.0%
1/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Congenital, familial and genetic disorders
Polydactyly
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
11.1%
1/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Injury, poisoning and procedural complications
Exposure to communicable disease
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
11.1%
1/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
12.5%
1/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/161 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/163 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/144 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/156 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/159 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/12 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/10 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
12.5%
1/8 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/11 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
0.00%
0/9 • Maternal participants-Local reactions/systemic events: From Day (D) 1 to 7 after dose 1 and 2; SAEs: from dose 1 on D 1 up to 6 months (M) after delivery (approx 10 M) (BNT162b2 30 mcg) and up to 1 M after delivery (approx 5 M) (placebo); placebo then BNT162b2: from Dose 3 up to 1 M after Dose 4 (approx 2 M); other AEs: from dose 1 up to 1 M after dose 2 (approx 2 M); (placebo then BNT162b2): from Dose 3 up to 1 M after Dose 4 (approx 2 M). For infants-SAEs and AESIs: from birth up to 6 M of age
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other, or a participant may have experienced both serious and non-serious event. Safety population for maternal and infants was evaluated. Systematic events include local reactions and systemic events recorded by participants in e-diary and non-systematic events include all other AEs.
|
Additional Information
BioNTech clinical trials patient information
BioNTech SE
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor (or its agents) has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER