Trial Outcomes & Findings for Study of a Candidate Clostridium Difficile Toxoid Vaccine in Subjects at Risk for C. Difficile Infection (NCT NCT01887912)
NCT ID: NCT01887912
Last Updated: 2022-03-28
Results Overview
Symptomatic PCR-confirmed CDI cases were defined as the number of participants with combination of clinical and laboratory findings. Clinical components were: \>= 3 loose stools in \<= 24 hours, loose stools (defined as type 6 \[fluffy pieces with ragged edges, mushy\] or type 7 \[watery, no solid pieces\] according to the Bristol Stool Chart) lasting \>= 24 hours. Laboratory findings were: stool sample positive for C. difficile Toxin B by PCR at central laboratory or diagnosis of pseudomembranous colitis visualized at colonoscopy.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
9302 participants
Primary outcome timeframe
Up to 3 years post injection 1
Results posted on
2022-03-28
Participant Flow
Study participants were enrolled in the study from 30 July 2013 to 17 November 2017.
A total of 9302 participants were enrolled and randomized in the study.
Participant milestones
| Measure |
C. Difficile Vaccine Group
Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).
|
Placebo Group
Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).
|
|---|---|---|
|
Overall Study
STARTED
|
6201
|
3101
|
|
Overall Study
Safety Population
|
6113
|
3057
|
|
Overall Study
COMPLETED
|
4809
|
2370
|
|
Overall Study
NOT COMPLETED
|
1392
|
731
|
Reasons for withdrawal
| Measure |
C. Difficile Vaccine Group
Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).
|
Placebo Group
Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).
|
|---|---|---|
|
Overall Study
Serious adverse event
|
400
|
198
|
|
Overall Study
Other Adverse Event
|
34
|
15
|
|
Overall Study
Protocol Violation
|
67
|
37
|
|
Overall Study
Lost to Follow-up
|
163
|
74
|
|
Overall Study
Withdrawal by Subject
|
606
|
349
|
|
Overall Study
Other
|
122
|
58
|
Baseline Characteristics
Study of a Candidate Clostridium Difficile Toxoid Vaccine in Subjects at Risk for C. Difficile Infection
Baseline characteristics by cohort
| Measure |
C. Difficile Vaccine Group
n=6201 Participants
Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).
|
Placebo Group
n=3101 Participants
Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).
|
Total
n=9302 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.9 years
STANDARD_DEVIATION 8.86 • n=93 Participants
|
65.8 years
STANDARD_DEVIATION 8.87 • n=4 Participants
|
65.8 years
STANDARD_DEVIATION 8.86 • n=27 Participants
|
|
Sex: Female, Male
Female
|
2629 Participants
n=93 Participants
|
1294 Participants
n=4 Participants
|
3923 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
3572 Participants
n=93 Participants
|
1807 Participants
n=4 Participants
|
5379 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
330 Participants
n=93 Participants
|
171 Participants
n=4 Participants
|
501 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2780 Participants
n=93 Participants
|
1390 Participants
n=4 Participants
|
4170 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3091 Participants
n=93 Participants
|
1540 Participants
n=4 Participants
|
4631 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
795 Participants
n=93 Participants
|
398 Participants
n=4 Participants
|
1193 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
206 Participants
n=93 Participants
|
102 Participants
n=4 Participants
|
308 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
2983 Participants
n=93 Participants
|
1487 Participants
n=4 Participants
|
4470 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2198 Participants
n=93 Participants
|
1099 Participants
n=4 Participants
|
3297 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Up to 3 years post injection 1Population: Analysis was performed on modified intent-to-treat (mITT) population which included all participants who received at least 1 injection and were analyzed according to the group to which they were randomized.
Symptomatic PCR-confirmed CDI cases were defined as the number of participants with combination of clinical and laboratory findings. Clinical components were: \>= 3 loose stools in \<= 24 hours, loose stools (defined as type 6 \[fluffy pieces with ragged edges, mushy\] or type 7 \[watery, no solid pieces\] according to the Bristol Stool Chart) lasting \>= 24 hours. Laboratory findings were: stool sample positive for C. difficile Toxin B by PCR at central laboratory or diagnosis of pseudomembranous colitis visualized at colonoscopy.
Outcome measures
| Measure |
C. Difficile Vaccine Group
n=6173 Participants
Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).
|
Placebo Group
n=3085 Participants
Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).
|
|---|---|---|
|
Number of Participants With Symptomatic Polymerase Chain Reaction (PCR)-Confirmed Primary C. Difficile Infection (CDI) Cases
|
34 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Up to 3 years post injection 1Population: Analysis was performed on participants with protocol-defined (PCR confirmed) primary CDI cases.
Severe CDI cases were defined as number of participants with at least one of the following symptoms: fever \>= 38.5 degree Celsius (°C), white blood cell count \>= 15,000 cells/mm\^3, ileus, pseudomembranous colitis, serum albumin \<3 gram per deciliter, abdominal distension, abdominal tenderness, or admission to the intensive care unit within 7 days of CDI diagnosis.
Outcome measures
| Measure |
C. Difficile Vaccine Group
n=34 Participants
Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).
|
Placebo Group
n=16 Participants
Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).
|
|---|---|---|
|
Number of Participants With Severe PCR-Confirmed Primary CDI Cases
|
9 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to 3 years post injection 1Population: Analysis was performed on participants with protocol-defined PCR confirmed CDI cases.
Loose stools were defined as type 6 (fluffy pieces with ragged edges, mushy) or type 7 (watery, no solid pieces) according to the Bristol Stool Chart. In this outcome measure, participants with number of loose stool episodes (categorized as: loose stool episodes less than 3, 3 to 6, 7 to 10, 11 to 15 and greater than 15) were reported.
Outcome measures
| Measure |
C. Difficile Vaccine Group
n=34 Participants
Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).
|
Placebo Group
n=16 Participants
Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).
|
|---|---|---|
|
Number of Participants With Loose Stool Episodes
>15
|
13 Participants
|
6 Participants
|
|
Number of Participants With Loose Stool Episodes
<3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Loose Stool Episodes
3 to 6
|
7 Participants
|
4 Participants
|
|
Number of Participants With Loose Stool Episodes
7 to 10
|
7 Participants
|
2 Participants
|
|
Number of Participants With Loose Stool Episodes
11 to 15
|
7 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 3 years post injection 1Population: PPEAS: participants who had at least 1 injection, no relevant protocol deviations (not meet inclusion criteria/ met exclusion criteria, not receive any vaccine/not received in proper time window, received different vaccine than randomized, preparation and / or administration of vaccine not done per protocol, received protocol-restricted therapy).
Symptomatic PCR confirmed CDI cases were defined as the number of participants with combination of clinical and laboratory findings. Clinical components were: \>= 3 loose stools in \<= 24 hours, loose stools (defined as type 6 \[fluffy pieces with ragged edges, mushy\] or type 7 \[watery, no solid pieces\] according to the Bristol Stool Chart) lasting \>= 24 hours. Laboratory findings were: stool sample positive for C. difficile Toxin B by PCR at central laboratory or diagnosis of pseudomembranous colitis visualized at colonoscopy. Analysis was performed on per-protocol efficacy analysis set (PPEAS).
Outcome measures
| Measure |
C. Difficile Vaccine Group
n=4786 Participants
Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).
|
Placebo Group
n=2378 Participants
Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).
|
|---|---|---|
|
Number of Participants With Symptomatic PCR Confirmed CDI Cases: Per-Protocol Population
|
23 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Day 0, Day 14, Day 30, Day 60, Day 210, Day 390, Day 570, Day 750, Day 930, and Day 1110Population: Analysis was performed on Per Protocol Immunogenicity Analysis Set. Here, 'number analyzed' = participants with available data for each specified category.
Serum antibody concentrations against toxins A and B were measured by ELISA and expressed as geometric mean concentration (GMC). The 2-sided 95% Confidence Interval (CI) of GMC was based on the Student t-distribution. Analysis was performed on Per Protocol Immunogenicity Analysis Set, which included participants who had at least 1 injection, no relevant protocol deviations (not met inclusion criteria/ met exclusion criteria, not received vaccine/ not received in proper time window, received different vaccine than randomized, preparation and/ or administration of vaccine not per protocol, protocol-restricted therapy, not provided post-dose serology sample/serology sample did not produced a valid test result).
Outcome measures
| Measure |
C. Difficile Vaccine Group
n=471 Participants
Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).
|
Placebo Group
n=236 Participants
Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).
|
|---|---|---|
|
Serum Antibody Concentrations Against Toxins A and B Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Toxin A ImunnoglobulinG (IgG): Day 0
|
0.957 ELISA units per milliliter (EU/mL)
Interval 0.897 to 1.02
|
0.999 ELISA units per milliliter (EU/mL)
Interval 0.912 to 1.09
|
|
Serum Antibody Concentrations Against Toxins A and B Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Toxin B IgG: Day 750
|
2.86 ELISA units per milliliter (EU/mL)
Interval 2.14 to 3.84
|
1.11 ELISA units per milliliter (EU/mL)
Interval 0.84 to 1.47
|
|
Serum Antibody Concentrations Against Toxins A and B Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Toxin A IgG: Day 14
|
3.19 ELISA units per milliliter (EU/mL)
Interval 2.68 to 3.8
|
0.913 ELISA units per milliliter (EU/mL)
Interval 0.849 to 0.983
|
|
Serum Antibody Concentrations Against Toxins A and B Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Toxin A IgG: Day 30
|
12.2 ELISA units per milliliter (EU/mL)
Interval 10.4 to 14.3
|
0.959 ELISA units per milliliter (EU/mL)
Interval 0.889 to 1.03
|
|
Serum Antibody Concentrations Against Toxins A and B Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Toxin A IgG: Day 60
|
43.7 ELISA units per milliliter (EU/mL)
Interval 38.1 to 50.2
|
0.933 ELISA units per milliliter (EU/mL)
Interval 0.867 to 1.0
|
|
Serum Antibody Concentrations Against Toxins A and B Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Toxin A IgG: Day 210
|
12.0 ELISA units per milliliter (EU/mL)
Interval 10.5 to 13.8
|
0.944 ELISA units per milliliter (EU/mL)
Interval 0.865 to 1.03
|
|
Serum Antibody Concentrations Against Toxins A and B Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Toxin A IgG: Day 390
|
6.02 ELISA units per milliliter (EU/mL)
Interval 5.23 to 6.93
|
0.955 ELISA units per milliliter (EU/mL)
Interval 0.856 to 1.06
|
|
Serum Antibody Concentrations Against Toxins A and B Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Toxin A IgG: Day 570
|
4.50 ELISA units per milliliter (EU/mL)
Interval 3.86 to 5.25
|
0.908 ELISA units per milliliter (EU/mL)
Interval 0.834 to 0.989
|
|
Serum Antibody Concentrations Against Toxins A and B Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Toxin A IgG: Day 750
|
4.02 ELISA units per milliliter (EU/mL)
Interval 3.38 to 4.78
|
0.856 ELISA units per milliliter (EU/mL)
Interval 0.776 to 0.944
|
|
Serum Antibody Concentrations Against Toxins A and B Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Toxin A IgG: Day 930
|
3.83 ELISA units per milliliter (EU/mL)
Interval 3.02 to 4.85
|
0.902 ELISA units per milliliter (EU/mL)
Interval 0.796 to 1.02
|
|
Serum Antibody Concentrations Against Toxins A and B Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Toxin A IgG: Day 1110
|
3.75 ELISA units per milliliter (EU/mL)
Interval 2.64 to 5.34
|
1.09 ELISA units per milliliter (EU/mL)
Interval 0.786 to 1.5
|
|
Serum Antibody Concentrations Against Toxins A and B Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Toxin B IgG: Day 0
|
1.40 ELISA units per milliliter (EU/mL)
Interval 1.24 to 1.57
|
1.49 ELISA units per milliliter (EU/mL)
Interval 1.24 to 1.79
|
|
Serum Antibody Concentrations Against Toxins A and B Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Toxin B IgG: Day 14
|
4.36 ELISA units per milliliter (EU/mL)
Interval 3.37 to 5.64
|
1.56 ELISA units per milliliter (EU/mL)
Interval 1.29 to 1.89
|
|
Serum Antibody Concentrations Against Toxins A and B Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Toxin B IgG: Day 30
|
10.0 ELISA units per milliliter (EU/mL)
Interval 7.85 to 12.8
|
1.46 ELISA units per milliliter (EU/mL)
Interval 1.21 to 1.75
|
|
Serum Antibody Concentrations Against Toxins A and B Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Toxin B IgG: Day 60
|
24.8 ELISA units per milliliter (EU/mL)
Interval 20.1 to 30.6
|
1.42 ELISA units per milliliter (EU/mL)
Interval 1.18 to 1.71
|
|
Serum Antibody Concentrations Against Toxins A and B Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Toxin B IgG: Day 210
|
6.62 ELISA units per milliliter (EU/mL)
Interval 5.36 to 8.19
|
1.31 ELISA units per milliliter (EU/mL)
Interval 1.07 to 1.61
|
|
Serum Antibody Concentrations Against Toxins A and B Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Toxin B IgG: Day 390
|
3.98 ELISA units per milliliter (EU/mL)
Interval 3.15 to 5.02
|
1.24 ELISA units per milliliter (EU/mL)
Interval 0.991 to 1.56
|
|
Serum Antibody Concentrations Against Toxins A and B Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Toxin B IgG: Day 570
|
3.37 ELISA units per milliliter (EU/mL)
Interval 2.63 to 4.32
|
1.15 ELISA units per milliliter (EU/mL)
Interval 0.905 to 1.47
|
|
Serum Antibody Concentrations Against Toxins A and B Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Toxin B IgG: Day 930
|
2.42 ELISA units per milliliter (EU/mL)
Interval 1.65 to 3.55
|
1.13 ELISA units per milliliter (EU/mL)
Interval 0.812 to 1.58
|
|
Serum Antibody Concentrations Against Toxins A and B Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Toxin B IgG: Day 1110
|
3.46 ELISA units per milliliter (EU/mL)
Interval 2.06 to 5.81
|
0.966 ELISA units per milliliter (EU/mL)
Interval 0.592 to 1.58
|
SECONDARY outcome
Timeframe: Day 60Population: Analysis was performed on Per Protocol Immunogenicity Analysis Set. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure and 'number analyzed' = participants with available data for each specified category.
Percentage of Participants with \>= 2 and 4-fold rise in serum antibody concentrations against toxins A and B were measured by ELISA. The 2-sided 95% Cl of the percentage was based on Exact method calculations.
Outcome measures
| Measure |
C. Difficile Vaccine Group
n=436 Participants
Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).
|
Placebo Group
n=220 Participants
Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).
|
|---|---|---|
|
Percentage of Participants With >= 2 and 4-Fold Rise in Serum Antibody Concentrations From Baseline Against Toxins A and B Measured by ELISA
Toxin A IgG: >=2
|
93.3 percentage of participants
Interval 90.5 to 95.5
|
0.9 percentage of participants
Interval 0.1 to 3.3
|
|
Percentage of Participants With >= 2 and 4-Fold Rise in Serum Antibody Concentrations From Baseline Against Toxins A and B Measured by ELISA
Toxin A IgG: >=4
|
88.9 percentage of participants
Interval 85.6 to 91.7
|
0.0 percentage of participants
Interval 0.0 to 1.7
|
|
Percentage of Participants With >= 2 and 4-Fold Rise in Serum Antibody Concentrations From Baseline Against Toxins A and B Measured by ELISA
Toxin B IgG: >=2
|
82.2 percentage of participants
Interval 78.3 to 85.7
|
4.6 percentage of participants
Interval 2.2 to 8.3
|
|
Percentage of Participants With >= 2 and 4-Fold Rise in Serum Antibody Concentrations From Baseline Against Toxins A and B Measured by ELISA
Toxin B IgG: >=4
|
73.2 percentage of participants
Interval 68.8 to 77.3
|
0.5 percentage of participants
Interval 0.0 to 2.5
|
SECONDARY outcome
Timeframe: Day 0 and Day 60Population: Analysis was performed on participants with protocol-defined (PCR confirmed) primary CDI cases. Here, 'number analyzed' = participants with available data for each specified category.
Serum antibody concentrations against toxins A and B were measured by ELISA and expressed as GMC. The 2-sided 95% CI GMC was based on the Student t-distribution. Symptomatic PCR-confirmed CDI cases were defined as the number of participants with combination of clinical and laboratory findings. Clinical components were: \>= 3 loose stools in \<= 24 hours, loose stools (defined as type 6 \[fluffy pieces with ragged edges, mushy\] or type 7 \[watery, no solid pieces\] according to the Bristol Stool Chart) lasting \>= 24 hours. Laboratory findings were: stool sample positive for C. difficile Toxin B by PCR at central laboratory or diagnosis of pseudomembranous colitis visualized at colonoscopy.
Outcome measures
| Measure |
C. Difficile Vaccine Group
n=34 Participants
Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).
|
Placebo Group
n=16 Participants
Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).
|
|---|---|---|
|
Serum Antibody Concentrations Against Toxins A and B Measured by ELISA in Participants With CDI
Toxin A IgG: Day 0
|
1.15 EU/mL
Interval 0.821 to 1.62
|
1.04 EU/mL
Interval 0.661 to 1.64
|
|
Serum Antibody Concentrations Against Toxins A and B Measured by ELISA in Participants With CDI
Toxin A IgG: Day 60
|
42.1 EU/mL
Interval 18.0 to 98.3
|
1.06 EU/mL
Interval 0.632 to 1.76
|
|
Serum Antibody Concentrations Against Toxins A and B Measured by ELISA in Participants With CDI
Toxin B IgG: Day 0
|
1.41 EU/mL
Interval 0.762 to 2.62
|
1.05 EU/mL
Interval 0.504 to 2.2
|
|
Serum Antibody Concentrations Against Toxins A and B Measured by ELISA in Participants With CDI
Toxin B IgG: Day 60
|
19.3 EU/mL
Interval 6.65 to 56.2
|
1.13 EU/mL
Interval 0.609 to 2.11
|
SECONDARY outcome
Timeframe: Day 0, Day 14, Day 30, Day 60, Day 210, Day 390, Day 570, Day 750, Day 930, and Day 1110Population: Analysis was performed on Per Protocol Immunogenicity Analysis Set. Here, 'number analyzed' = participants with available data for each specified category.
Serum antibody concentrations against toxins A and B were measured by TNA and expressed as geometric mean titer (GMT). The 2-sided 95% Cl of GMT was based on the Student t-distribution.
Outcome measures
| Measure |
C. Difficile Vaccine Group
n=471 Participants
Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).
|
Placebo Group
n=236 Participants
Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).
|
|---|---|---|
|
Serum Antibody Concentrations Against Toxins A and B Measured by Toxin Neutralization Assay (TNA)
Toxin A TNA: Day 0
|
9.86 Titer (1/dilution)
Interval 9.22 to 10.5
|
10.1 Titer (1/dilution)
Interval 9.12 to 11.2
|
|
Serum Antibody Concentrations Against Toxins A and B Measured by Toxin Neutralization Assay (TNA)
Toxin A TNA: Day 14
|
28.5 Titer (1/dilution)
Interval 22.7 to 35.8
|
9.86 Titer (1/dilution)
Interval 8.96 to 10.8
|
|
Serum Antibody Concentrations Against Toxins A and B Measured by Toxin Neutralization Assay (TNA)
Toxin A TNA: Day 30
|
50.5 Titer (1/dilution)
Interval 40.9 to 62.3
|
9.97 Titer (1/dilution)
Interval 9.09 to 10.9
|
|
Serum Antibody Concentrations Against Toxins A and B Measured by Toxin Neutralization Assay (TNA)
Toxin A TNA: Day 60
|
269 Titer (1/dilution)
Interval 226.0 to 322.0
|
9.82 Titer (1/dilution)
Interval 8.95 to 10.8
|
|
Serum Antibody Concentrations Against Toxins A and B Measured by Toxin Neutralization Assay (TNA)
Toxin A TNA: Day 210
|
269 Titer (1/dilution)
Interval 228.0 to 317.0
|
10.3 Titer (1/dilution)
Interval 9.09 to 11.7
|
|
Serum Antibody Concentrations Against Toxins A and B Measured by Toxin Neutralization Assay (TNA)
Toxin A TNA: Day 390
|
217 Titer (1/dilution)
Interval 183.0 to 259.0
|
10.1 Titer (1/dilution)
Interval 8.86 to 11.5
|
|
Serum Antibody Concentrations Against Toxins A and B Measured by Toxin Neutralization Assay (TNA)
Toxin A TNA: Day 570
|
184 Titer (1/dilution)
Interval 153.0 to 223.0
|
9.86 Titer (1/dilution)
Interval 8.76 to 11.1
|
|
Serum Antibody Concentrations Against Toxins A and B Measured by Toxin Neutralization Assay (TNA)
Toxin A TNA: Day 750
|
186 Titer (1/dilution)
Interval 148.0 to 234.0
|
10.2 Titer (1/dilution)
Interval 8.66 to 12.0
|
|
Serum Antibody Concentrations Against Toxins A and B Measured by Toxin Neutralization Assay (TNA)
Toxin A TNA: Day 930
|
173 Titer (1/dilution)
Interval 125.0 to 240.0
|
10.7 Titer (1/dilution)
Interval 8.57 to 13.4
|
|
Serum Antibody Concentrations Against Toxins A and B Measured by Toxin Neutralization Assay (TNA)
Toxin A TNA: Day 1110
|
212 Titer (1/dilution)
Interval 137.0 to 329.0
|
10.2 Titer (1/dilution)
Interval 8.03 to 12.9
|
|
Serum Antibody Concentrations Against Toxins A and B Measured by Toxin Neutralization Assay (TNA)
Toxin B TNA: Day 0
|
12.3 Titer (1/dilution)
Interval 11.2 to 13.6
|
13.2 Titer (1/dilution)
Interval 11.2 to 15.6
|
|
Serum Antibody Concentrations Against Toxins A and B Measured by Toxin Neutralization Assay (TNA)
Toxin B TNA: Day 14
|
32.7 Titer (1/dilution)
Interval 25.3 to 42.2
|
13.3 Titer (1/dilution)
Interval 11.3 to 15.7
|
|
Serum Antibody Concentrations Against Toxins A and B Measured by Toxin Neutralization Assay (TNA)
Toxin B TNA: Day 30
|
37.8 Titer (1/dilution)
Interval 29.3 to 48.8
|
13.4 Titer (1/dilution)
Interval 11.3 to 15.8
|
|
Serum Antibody Concentrations Against Toxins A and B Measured by Toxin Neutralization Assay (TNA)
Toxin B TNA: Day 60
|
43.9 Titer (1/dilution)
Interval 34.0 to 56.6
|
14.3 Titer (1/dilution)
Interval 11.9 to 17.2
|
|
Serum Antibody Concentrations Against Toxins A and B Measured by Toxin Neutralization Assay (TNA)
Toxin B TNA: Day 210
|
41.4 Titer (1/dilution)
Interval 32.4 to 53.1
|
13.2 Titer (1/dilution)
Interval 11.1 to 15.5
|
|
Serum Antibody Concentrations Against Toxins A and B Measured by Toxin Neutralization Assay (TNA)
Toxin B TNA: Day 390
|
38.4 Titer (1/dilution)
Interval 30.0 to 49.0
|
13.5 Titer (1/dilution)
Interval 11.3 to 16.1
|
|
Serum Antibody Concentrations Against Toxins A and B Measured by Toxin Neutralization Assay (TNA)
Toxin B TNA: Day 570
|
35.7 Titer (1/dilution)
Interval 27.7 to 46.0
|
13.7 Titer (1/dilution)
Interval 11.3 to 16.8
|
|
Serum Antibody Concentrations Against Toxins A and B Measured by Toxin Neutralization Assay (TNA)
Toxin B TNA: Day 750
|
34.3 Titer (1/dilution)
Interval 25.1 to 46.9
|
14.6 Titer (1/dilution)
Interval 11.2 to 18.9
|
|
Serum Antibody Concentrations Against Toxins A and B Measured by Toxin Neutralization Assay (TNA)
Toxin B TNA: Day 930
|
31.0 Titer (1/dilution)
Interval 21.1 to 45.6
|
17.0 Titer (1/dilution)
Interval 12.3 to 23.5
|
|
Serum Antibody Concentrations Against Toxins A and B Measured by Toxin Neutralization Assay (TNA)
Toxin B TNA: Day 1110
|
46.8 Titer (1/dilution)
Interval 26.1 to 84.1
|
14.0 Titer (1/dilution)
Interval 9.05 to 21.7
|
SECONDARY outcome
Timeframe: Day 60Population: Analysis was performed on Per Protocol Immunogenicity Analysis Set. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and 'number analyzed' = participants with evaluable data for each specified category.
Percentage of Participants with \>= 2 and 4-fold rise in serum antibody concentrations against toxins A and B were measured by TNA. The 2-sided 95% CI of the percentage was based on Exact method calculations.
Outcome measures
| Measure |
C. Difficile Vaccine Group
n=436 Participants
Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).
|
Placebo Group
n=220 Participants
Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).
|
|---|---|---|
|
Percentage of Participants With >= 2 and 4-Fold Rise in Serum Antibody Concentrations From Baseline Against Toxins A and B Measured by TNA
Toxin A TNA: >=2
|
85.6 percentage of participants
Interval 81.9 to 88.8
|
0.5 percentage of participants
Interval 0.0 to 2.5
|
|
Percentage of Participants With >= 2 and 4-Fold Rise in Serum Antibody Concentrations From Baseline Against Toxins A and B Measured by TNA
Toxin A TNA: >=4
|
78.2 percentage of participants
Interval 74.0 to 82.0
|
0.5 percentage of participants
Interval 0.0 to 2.5
|
|
Percentage of Participants With >= 2 and 4-Fold Rise in Serum Antibody Concentrations From Baseline Against Toxins A and B Measured by TNA
Toxin B TNA: >=2
|
30.9 percentage of participants
Interval 26.5 to 35.5
|
2.8 percentage of participants
Interval 1.0 to 5.9
|
|
Percentage of Participants With >= 2 and 4-Fold Rise in Serum Antibody Concentrations From Baseline Against Toxins A and B Measured by TNA
Toxin B TNA: >=4
|
27.4 percentage of participants
Interval 23.2 to 31.8
|
1.8 percentage of participants
Interval 0.5 to 4.7
|
SECONDARY outcome
Timeframe: Day 0 and Day 60Population: Analysis was performed on participants with protocol-defined (PCR confirmed) primary CDI cases. Here, 'number analyzed' = participants with available data for each specified category.
Serum antibody concentrations against toxins A and B were measured by TNA and were expressed as GMT. The 2-sided 95% CI GMC was based on the Student t-distribution. Symptomatic PCR confirmed CDI cases were defined as the number of participants with combination of clinical and laboratory findings. Clinical components were: \>= 3 loose stools in \<= 24 hours, loose stools (defined as type 6 \[fluffy pieces with ragged edges, mushy\] or type 7 \[watery, no solid pieces\] according to the Bristol Stool Chart) lasting \>= 24 hours. Laboratory findings were: stool sample positive for C. difficile Toxin B by PCR at central laboratory or diagnosis of pseudomembranous colitis visualized at colonoscopy.
Outcome measures
| Measure |
C. Difficile Vaccine Group
n=34 Participants
Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).
|
Placebo Group
n=16 Participants
Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).
|
|---|---|---|
|
Serum Antibody Concentrations Against Toxins A and B Measured by TNA in Participants With CDI
Toxin B TNA: Day 0
|
16.7 Titer (1/dilution)
Interval 9.46 to 29.5
|
11.1 Titer (1/dilution)
Interval 7.57 to 16.3
|
|
Serum Antibody Concentrations Against Toxins A and B Measured by TNA in Participants With CDI
Toxin A TNA: Day 0
|
12.4 Titer (1/dilution)
Interval 8.59 to 17.9
|
12.0 Titer (1/dilution)
Interval 6.27 to 23.0
|
|
Serum Antibody Concentrations Against Toxins A and B Measured by TNA in Participants With CDI
Toxin A TNA: Day 60
|
176 Titer (1/dilution)
Interval 83.4 to 371.0
|
10.7 Titer (1/dilution)
Interval 5.77 to 19.7
|
|
Serum Antibody Concentrations Against Toxins A and B Measured by TNA in Participants With CDI
Toxin B TNA: Day 60
|
53.0 Titer (1/dilution)
Interval 18.3 to 153.0
|
13.1 Titer (1/dilution)
Interval 8.11 to 21.0
|
SECONDARY outcome
Timeframe: Day 0 to Day 6 after any vaccinationPopulation: Analysis was performed on all participants who received vaccine and were evaluable for reactogenicity. Here, 'number analyzed' = participants with available data for each specified category.
Solicited injection site reactions: pain, erythema, and swelling. Pain: Grade 1: no interference with activity, Grade 2: some interference with activity, Grade 3: significant; prevents daily activity; Erythema and swelling: Grade 1: \>= 25 to \<=50 mm, Grade 2: \>51 to \<=100 mm, Grade 3: \>100 mm. Solicited systemic reactions: fever, headache, malaise, myalgia, and arthralgia. Fever: Grade 1: \>= 38.0°C to \<=38.4°C or \>= 100.4° Fahrenheit (F) to \<=101.1°F, Grade 2: \>=38.5°C to \<= 38.9°C or \>=101.2°F to \<=102.0°F, Grade 3: \>=39.0°C or \>=102.1°F. Headache, malaise, and myalgia: Grade 1: no interference with activity, Grade 2: some interference with activity, Grade 3: significant; prevents daily activity; Arthralgia: Grade 1: free range of motion but complains of pain or discomfort, Grade 2: decreased range of motion due to pain or discomfort, Grade 3: unwilling to move due to pain.
Outcome measures
| Measure |
C. Difficile Vaccine Group
n=1227 Participants
Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).
|
Placebo Group
n=608 Participants
Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).
|
|---|---|---|
|
Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions
Injection site Pain
|
38.6 percentage of participants
|
13.5 percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions
Injection site Erythema
|
4.2 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions
Injection site Swelling
|
3.8 percentage of participants
|
0.3 percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions
Fever
|
4.8 percentage of participants
|
5.7 percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions
Headache
|
25.3 percentage of participants
|
22.5 percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions
Malaise
|
23.9 percentage of participants
|
19.6 percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions
Myalgia
|
26.6 percentage of participants
|
21.2 percentage of participants
|
|
Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions
Arthralgia
|
19.5 percentage of participants
|
16.7 percentage of participants
|
Adverse Events
C. Difficile Vaccine Group
Serious events: 1662 serious events
Other events: 1347 other events
Deaths: 255 deaths
Placebo Group
Serious events: 851 serious events
Other events: 401 other events
Deaths: 127 deaths
Serious adverse events
| Measure |
C. Difficile Vaccine Group
n=6113 participants at risk
Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).
|
Placebo Group
n=3057 participants at risk
Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.31%
19/6113 • Number of events 20 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.36%
11/3057 • Number of events 13 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Blood and lymphatic system disorders
Antiphospholipid Syndrome
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.07%
4/6113 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Blood and lymphatic system disorders
Haemolytic Anaemia
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Blood and lymphatic system disorders
Haemorrhagic Anaemia
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.16%
5/3057 • Number of events 5 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Blood and lymphatic system disorders
Microcytic Anaemia
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Blood and lymphatic system disorders
Nephrogenic Anaemia
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Blood and lymphatic system disorders
Normochromic Normocytic Anaemia
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.21%
13/6113 • Number of events 15 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.92%
56/6113 • Number of events 59 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.72%
22/3057 • Number of events 24 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Angina Pectoris
|
0.31%
19/6113 • Number of events 20 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.33%
10/3057 • Number of events 10 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Angina Unstable
|
0.44%
27/6113 • Number of events 32 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.29%
9/3057 • Number of events 15 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Aortic Valve Incompetence
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Aortic Valve Stenosis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Arrhythmia
|
0.15%
9/6113 • Number of events 9 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Arrhythmia Supraventricular
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Arteriosclerosis Coronary Artery
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.69%
42/6113 • Number of events 53 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.46%
14/3057 • Number of events 15 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Atrial Flutter
|
0.05%
3/6113 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Atrial Tachycardia
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Atrial Thrombosis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Atrioventricular Block
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Atrioventricular Block Complete
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Bradyarrhythmia
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Bradycardia
|
0.08%
5/6113 • Number of events 6 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.16%
5/3057 • Number of events 5 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Bundle Branch Block Left
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Cardiac Arrest
|
0.16%
10/6113 • Number of events 11 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.26%
8/3057 • Number of events 8 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Cardiac Disorder
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Cardiac Failure
|
0.56%
34/6113 • Number of events 40 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.52%
16/3057 • Number of events 36 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Cardiac Failure Acute
|
0.26%
16/6113 • Number of events 22 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.20%
6/3057 • Number of events 7 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Cardiac Failure Chronic
|
0.05%
3/6113 • Number of events 5 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
1.1%
69/6113 • Number of events 102 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.95%
29/3057 • Number of events 37 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Cardiac Tamponade
|
0.10%
6/6113 • Number of events 6 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Cardiac Valve Disease
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.16%
10/6113 • Number of events 11 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.10%
3/3057 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Cardiogenic Shock
|
0.13%
8/6113 • Number of events 9 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.16%
5/3057 • Number of events 5 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Cardiomyopathy
|
0.08%
5/6113 • Number of events 6 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Cardiopulmonary Failure
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Cardiorenal Syndrome
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Cor Pulmonale
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Coronary Artery Disease
|
0.36%
22/6113 • Number of events 23 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.23%
7/3057 • Number of events 7 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Coronary Artery Occlusion
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Coronary Artery Stenosis
|
0.11%
7/6113 • Number of events 8 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Coronary Artery Thrombosis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Heart Valve Incompetence
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Hypertensive Heart Disease
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Intracardiac Thrombus
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Ischaemic Cardiomyopathy
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Left Ventricular Failure
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Mitral Valve Incompetence
|
0.05%
3/6113 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Myocardial Infarction
|
0.44%
27/6113 • Number of events 27 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.52%
16/3057 • Number of events 16 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.13%
8/6113 • Number of events 8 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.10%
3/3057 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Palpitations
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Pericardial Effusion
|
0.08%
5/6113 • Number of events 5 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Pericarditis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Prinzmetal Angina
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Pulseless Electrical Activity
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Reperfusion Arrhythmia
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Right Ventricular Failure
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Sick Sinus Syndrome
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.10%
3/3057 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Sinoatrial Block
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Sinus Bradycardia
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Stress Cardiomyopathy
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Supraventricular Tachyarrhythmia
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Tachyarrhythmia
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Tricuspid Valve Incompetence
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Ventricle Rupture
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Ventricular Arrhythmia
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Ventricular Fibrillation
|
0.05%
3/6113 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.08%
5/6113 • Number of events 5 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.13%
4/3057 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Congenital, familial and genetic disorders
Anophthalmos
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Congenital, familial and genetic disorders
Cardiac Septal Defect
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Congenital, familial and genetic disorders
Ectopic Ureter
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Ear and labyrinth disorders
Deafness Neurosensory
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Ear and labyrinth disorders
Meniere's Disease
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Ear and labyrinth disorders
Sudden Hearing Loss
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Ear and labyrinth disorders
Vertigo
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Ear and labyrinth disorders
Vertigo Positional
|
0.07%
4/6113 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Endocrine disorders
Adrenal Insufficiency
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Endocrine disorders
Goitre
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Endocrine disorders
Hyperparathyroidism Primary
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Endocrine disorders
Thyroid Mass
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Eye disorders
Amaurosis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Eye disorders
Amaurosis Fugax
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Eye disorders
Aphakia
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Eye disorders
Cataract
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Eye disorders
Conjunctivochalasis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Eye disorders
Eyelid Ptosis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Eye disorders
Glaucoma
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Eye disorders
Phacolytic Glaucoma
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Eye disorders
Pterygium
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Eye disorders
Retinal Detachment
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Eye disorders
Retinal Vein Occlusion
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Eye disorders
Vitreous Haemorrhage
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Abdominal Adhesions
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Abdominal Hernia
|
0.05%
3/6113 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.23%
14/6113 • Number of events 14 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.36%
11/3057 • Number of events 15 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Abdominal Wall Haematoma
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Anal Fissure
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Anal Fistula
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Ascites
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Change Of Bowel Habit
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Colitis
|
0.08%
5/6113 • Number of events 5 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Colitis Ischaemic
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Colitis Microscopic
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Colonic Pseudo-Obstruction
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Colonic Stenosis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Constipation
|
0.15%
9/6113 • Number of events 9 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Crohn's Disease
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Dental Pulp Disorder
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Diabetic Gastroparesis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Diaphragmatic Hernia
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.13%
8/6113 • Number of events 8 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Diverticular Perforation
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Diverticulum
|
0.07%
4/6113 • Number of events 5 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Duodenal Ulcer
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Duodenal Ulcer Haemorrhage
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Enterovesical Fistula
|
0.02%
1/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Erosive Duodenitis
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Erosive Oesophagitis
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Faecaloma
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Food Poisoning
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Gastric Disorder
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Gastric Haemorrhage
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Gastric Ulcer Haemorrhage
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Gastric Ulcer Perforation
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Gastritis
|
0.13%
8/6113 • Number of events 8 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.13%
4/3057 • Number of events 5 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Gastritis Erosive
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Gastritis Haemorrhagic
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Gastroduodenal Ulcer
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Gastrointestinal Amyloidosis
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.21%
13/6113 • Number of events 13 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.20%
6/3057 • Number of events 6 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Gastrointestinal Hypomotility
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Gastrointestinal Obstruction
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Haematemesis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Hernial Eventration
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Hiatus Hernia
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Ileal Stenosis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Ileus
|
0.10%
6/6113 • Number of events 6 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Ileus Paralytic
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Impaired Gastric Emptying
|
0.02%
1/6113 • Number of events 5 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.07%
4/6113 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.10%
3/3057 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Inguinal Hernia, Obstructive
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Intestinal Haemorrhage
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.10%
6/6113 • Number of events 7 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Intestinal Perforation
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Intra-Abdominal Haemorrhage
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Large Intestinal Obstruction
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Large Intestine Polyp
|
0.08%
5/6113 • Number of events 5 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Lower Gastrointestinal Haemorrhage
|
0.07%
4/6113 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Melaena
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Mesenteric Artery Thrombosis
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Mesenteric Vein Thrombosis
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Nausea
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Oesophageal Obstruction
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Oesophageal Stenosis
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Oesophageal Varices Haemorrhage
|
0.03%
2/6113 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Oral Disorder
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Pancreatic Pseudocyst
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.10%
6/6113 • Number of events 7 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.10%
3/3057 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.07%
4/6113 • Number of events 5 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.20%
6/3057 • Number of events 6 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Pancreatitis Chronic
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Pancreatitis Relapsing
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Peptic Ulcer
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Periodontal Disease
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Peritoneal Adhesions
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Peritoneal Haemorrhage
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Proctalgia
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.07%
4/6113 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Rectal Prolapse
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.08%
5/6113 • Number of events 5 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Spigelian Hernia
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Thrombosis Mesenteric Vessel
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Umbilical Hernia
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Umbilical Hernia, Obstructive
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
0.08%
5/6113 • Number of events 5 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Varices Oesophageal
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Gastrointestinal disorders
Vomiting
|
0.07%
4/6113 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Asthenia
|
0.07%
4/6113 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Catheter Site Haemorrhage
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Chest Discomfort
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Chest Pain
|
0.82%
50/6113 • Number of events 56 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.62%
19/3057 • Number of events 27 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Death
|
0.13%
8/6113 • Number of events 8 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.20%
6/3057 • Number of events 6 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Device Dislocation
|
0.15%
9/6113 • Number of events 9 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Device Failure
|
0.05%
3/6113 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Device Issue
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Device Leakage
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Device Malfunction
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Device Occlusion
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Drug Interaction
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Fatigue
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
General Physical Health Deterioration
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
General Symptom
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Generalised Oedema
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Hernia Obstructive
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Hyperthermia
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Impaired Healing
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Implant Site Haematoma
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Inflammation
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Malaise
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Medical Device Complication
|
0.11%
7/6113 • Number of events 8 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.13%
4/3057 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Multi-Organ Failure
|
0.07%
4/6113 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.10%
3/3057 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Oedema
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Oedema Peripheral
|
0.05%
3/6113 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Pain
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.10%
3/3057 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Patient-Device Incompatibility
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Perforated Ulcer
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Polyp
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Pyrexia
|
0.08%
5/6113 • Number of events 5 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.10%
3/3057 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Spinal Pain
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Stent-Graft Endoleak
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Sudden Cardiac Death
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Sudden Death
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Surgical Failure
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Systemic Inflammatory Response Syndrome
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Hepatobiliary disorders
Bile Duct Obstruction
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Hepatobiliary disorders
Bile Duct Stenosis
|
0.02%
1/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Hepatobiliary disorders
Bile Duct Stone
|
0.05%
3/6113 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.10%
3/3057 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Hepatobiliary disorders
Cholangitis
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.10%
3/3057 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Hepatobiliary disorders
Cholangitis Acute
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.11%
7/6113 • Number of events 7 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.23%
7/3057 • Number of events 7 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Hepatobiliary disorders
Cholecystitis Chronic
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.11%
7/6113 • Number of events 7 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.20%
6/3057 • Number of events 6 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Hepatobiliary disorders
Cirrhosis Alcoholic
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Hepatobiliary disorders
Gallbladder Polyp
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Hepatobiliary disorders
Hepatic Cirrhosis
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Hepatobiliary disorders
Hepatic Cyst
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Hepatobiliary disorders
Hepatic Failure
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Hepatobiliary disorders
Hepatitis Acute
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Hepatobiliary disorders
Hepatorenal Syndrome
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Hepatobiliary disorders
Hydrocholecystis
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Immune system disorders
Anaphylactic Reaction
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Immune system disorders
Anaphylactic Shock
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Immune system disorders
Device Allergy
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Immune system disorders
Food Allergy
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Immune system disorders
Secondary Immunodeficiency
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Abdominal Hernia Gangrenous
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Abdominal Infection
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Abdominal Sepsis
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.10%
3/3057 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Abdominal Wall Abscess
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Abscess
|
0.07%
4/6113 • Number of events 5 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Abscess Limb
|
0.07%
4/6113 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Anal Abscess
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Appendicitis
|
0.08%
5/6113 • Number of events 5 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Appendicitis Perforated
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Arteriovenous Graft Site Abscess
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Arthritis Bacterial
|
0.18%
11/6113 • Number of events 11 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.10%
3/3057 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Arthritis Infective
|
0.13%
8/6113 • Number of events 9 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.10%
3/3057 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Asymptomatic Bacteriuria
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Atypical Mycobacterial Infection
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Bacteraemia
|
0.13%
8/6113 • Number of events 9 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Bacterial Infection
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Bacterial Sepsis
|
0.07%
4/6113 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Bacterial Tracheitis
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Beta Haemolytic Streptococcal Infection
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Biliary Sepsis
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Breast Abscess
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Breast Cellulitis
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Bronchitis
|
0.18%
11/6113 • Number of events 11 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.10%
3/3057 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Bronchopneumonia
|
0.05%
3/6113 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Bursitis Infective
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Candida Sepsis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Cellulitis
|
1.0%
63/6113 • Number of events 78 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
1.2%
36/3057 • Number of events 41 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Chronic Hepatitis C
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.05%
3/6113 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Clostridium Difficile Infection
|
0.05%
3/6113 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Dengue Fever
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Dermo-Hypodermitis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Device Related Infection
|
0.29%
18/6113 • Number of events 22 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.39%
12/3057 • Number of events 14 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Diabetic Foot Infection
|
0.43%
26/6113 • Number of events 30 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.29%
9/3057 • Number of events 9 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Diabetic Gangrene
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Diarrhoea Infectious
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Disseminated Tuberculosis
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Diverticulitis
|
0.07%
4/6113 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Empyema
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Endocarditis Bacterial
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Enterobacter Pneumonia
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Enterocolitis Bacterial
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Enterocolitis Infectious
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Erysipelas
|
0.05%
3/6113 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Escherichia Bacteraemia
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Escherichia Sepsis
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Escherichia Urinary Tract Infection
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Gangrene
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Gastric Infection
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Gastroenteritis
|
0.16%
10/6113 • Number of events 10 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.20%
6/3057 • Number of events 6 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Gastroenteritis Viral
|
0.05%
3/6113 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Genital Herpes
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Graft Infection
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Groin Abscess
|
0.05%
3/6113 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Haematoma Infection
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Hepatic Cyst Infection
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Herpes Virus Infection
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Herpes Zoster
|
0.05%
3/6113 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Implant Site Infection
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Incision Site Infection
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Infected Skin Ulcer
|
0.03%
2/6113 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Infection
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Infection In An Immunocompromised Host
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Infective Exacerbation Of Bronchiectasis
|
0.03%
2/6113 • Number of events 6 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Infective Exacerbation Of Chronic Obstructive Airways Disease
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Infective Spondylitis
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Influenza
|
0.08%
5/6113 • Number of events 5 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Intervertebral Discitis
|
0.05%
3/6113 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Joint Abscess
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Kidney Infection
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Liver Abscess
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Lobar Pneumonia
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Localised Infection
|
0.07%
4/6113 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.13%
4/3057 • Number of events 5 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.11%
7/6113 • Number of events 7 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Lower Respiratory Tract Infection Viral
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Lung Infection
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Mediastinitis
|
0.07%
4/6113 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Meningitis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Mumps
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Mycobacterium Avium Complex Infection
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Nail Infection
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Neurological Infection
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Neurosyphilis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Orchitis
|
0.10%
6/6113 • Number of events 6 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Osteomyelitis
|
0.44%
27/6113 • Number of events 29 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.36%
11/3057 • Number of events 16 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Osteomyelitis Acute
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Osteomyelitis Chronic
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Otitis Externa
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Paraspinal Abscess
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Paronychia
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Perihepatic Abscess
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Perineal Abscess
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Periodontitis
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Peritonitis
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Peritonsillar Abscess
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Pneumonia
|
1.8%
107/6113 • Number of events 122 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
2.2%
67/3057 • Number of events 84 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Pneumonia Bacterial
|
0.08%
5/6113 • Number of events 9 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Pneumonia Necrotising
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Pneumonia Pneumococcal
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Pneumonia Staphylococcal
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Poliomyelitis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Post Procedural Cellulitis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Post Procedural Infection
|
0.11%
7/6113 • Number of events 7 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Post Procedural Pneumonia
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Post Procedural Sepsis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Postoperative Wound Infection
|
0.46%
28/6113 • Number of events 30 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.49%
15/3057 • Number of events 15 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Prostatic Abscess
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Psoas Abscess
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Pulmonary Sepsis
|
0.02%
1/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Pulmonary Tuberculosis
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Pyelonephritis
|
0.08%
5/6113 • Number of events 5 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Pyelonephritis Acute
|
0.11%
7/6113 • Number of events 8 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Renal Abscess
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.11%
7/6113 • Number of events 8 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.13%
4/3057 • Number of events 6 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Scrotal Abscess
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Sepsis
|
0.56%
34/6113 • Number of events 38 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.59%
18/3057 • Number of events 18 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Septic Arthritis Staphylococcal
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Septic Shock
|
0.43%
26/6113 • Number of events 27 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.43%
13/3057 • Number of events 13 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Sinusitis Bacterial
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Skin Bacterial Infection
|
0.05%
3/6113 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Skin Infection
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Soft Tissue Infection
|
0.05%
3/6113 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.13%
4/3057 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Staphylococcal Bacteraemia
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Staphylococcal Infection
|
0.07%
4/6113 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.10%
3/3057 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Staphylococcal Osteomyelitis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Staphylococcal Sepsis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Subcutaneous Abscess
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Tracheitis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Tracheobronchitis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Tuberculosis
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Urinary Bladder Abscess
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Urinary Tract Infection
|
1.5%
91/6113 • Number of events 116 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
1.2%
38/3057 • Number of events 47 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Urinary Tract Infection Bacterial
|
0.05%
3/6113 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Urinary Tract Infection Pseudomonal
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Urosepsis
|
0.18%
11/6113 • Number of events 12 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.20%
6/3057 • Number of events 6 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Viral Infection
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Wound Infection
|
0.08%
5/6113 • Number of events 5 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Infections and infestations
Wound Infection Bacterial
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Abdominal Wound Dehiscence
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Alcohol Poisoning
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Anaemia Postoperative
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Animal Bite
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.07%
4/6113 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.13%
4/3057 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Arterial Injury
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Bladder Injury
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Bone Fissure
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Cardiac Procedure Complication
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Cervical Vertebral Fracture
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Chemical Poisoning
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Coronary Artery Restenosis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Craniocerebral Injury
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Dislocation Of Vertebra
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Dural Tear
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Exposure To Toxic Agent
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Extradural Haematoma
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Facial Bones Fracture
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Fall
|
0.28%
17/6113 • Number of events 18 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.23%
7/3057 • Number of events 7 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Fat Embolism
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.08%
5/6113 • Number of events 5 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.18%
11/6113 • Number of events 12 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.13%
4/3057 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Forearm Fracture
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Heat Exhaustion
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Heat Stroke
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.13%
8/6113 • Number of events 8 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.20%
6/3057 • Number of events 7 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.07%
4/6113 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Incisional Hernia
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
0.20%
12/6113 • Number of events 16 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Joint Dislocation Postoperative
|
0.07%
4/6113 • Number of events 5 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Joint Injury
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Ligament Injury
|
0.03%
2/6113 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Ligament Rupture
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.07%
4/6113 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.05%
3/6113 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Mechanical Ventilation Complication
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Meniscus Injury
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.16%
5/3057 • Number of events 6 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Multiple Fractures
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.10%
3/3057 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Multiple Injuries
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Muscle Rupture
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.07%
4/6113 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Patella Fracture
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Pelvic Fracture
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Periprosthetic Fracture
|
0.10%
6/6113 • Number of events 7 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.16%
5/3057 • Number of events 6 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Pneumothorax Traumatic
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Post Concussion Syndrome
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Post Procedural Complication
|
0.29%
18/6113 • Number of events 18 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.36%
11/3057 • Number of events 13 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Post Procedural Discharge
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Post Procedural Haematoma
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Post Procedural Haematuria
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Post Procedural Haemorrhage
|
0.05%
3/6113 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.10%
3/3057 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Post Procedural Swelling
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Postoperative Fever
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Postoperative Ileus
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Postoperative Respiratory Failure
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Postoperative Thoracic Procedure Complication
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Postoperative Wound Complication
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Procedural Haemorrhage
|
0.07%
4/6113 • Number of events 5 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Procedural Hypotension
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Procedural Nausea
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Pubis Fracture
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Rectal Laceration Postoperative
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Renal Haematoma
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.10%
3/3057 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.16%
5/3057 • Number of events 5 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Scrotal Haematoma
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Skin Injury
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Stab Wound
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Stress Fracture
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
0.10%
6/6113 • Number of events 6 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.10%
3/3057 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Subdural Haemorrhage
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Tendon Rupture
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Thoracic Vertebral Fracture
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.07%
4/6113 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Toxicity To Various Agents
|
0.07%
4/6113 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Tracheostomy Malfunction
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Traumatic Arthritis
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Traumatic Intracranial Haemorrhage
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Urethral Injury
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Urethral Stricture Postoperative
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Vascular Bypass Dysfunction
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Vascular Graft Occlusion
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Vascular Graft Thrombosis
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Vascular Pseudoaneurysm
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Wound
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
0.05%
3/6113 • Number of events 5 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Investigations
Anticoagulation Drug Level Above Therapeutic
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Investigations
Aspiration Bronchial
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Investigations
Blood Creatinine Increased
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Investigations
Blood Potassium Decreased
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Investigations
Carbon Dioxide Abnormal
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Investigations
Cardiac Pacemaker Evaluation
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Investigations
Coagulation Time Prolonged
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Investigations
Electrocardiogram St Segment Elevation
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Investigations
Influenza A Virus Test Positive
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Investigations
International Normalised Ratio Increased
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Investigations
Oxygen Saturation Decreased
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Investigations
Prothrombin Time Abnormal
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Investigations
Transaminases Increased
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Investigations
Urine Output Decreased
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Metabolism and nutrition disorders
Central Obesity
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.08%
5/6113 • Number of events 5 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.20%
12/6113 • Number of events 15 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus Inadequate Control
|
0.13%
8/6113 • Number of events 11 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Metabolism and nutrition disorders
Diabetic Complication
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.05%
3/6113 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Metabolism and nutrition disorders
Electrolyte Imbalance
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.10%
3/3057 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Metabolism and nutrition disorders
Fluid Overload
|
0.07%
4/6113 • Number of events 6 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.16%
5/3057 • Number of events 13 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Metabolism and nutrition disorders
Gout
|
0.08%
5/6113 • Number of events 6 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.16%
10/6113 • Number of events 12 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.20%
6/3057 • Number of events 6 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Metabolism and nutrition disorders
Hyperglycaemic Hyperosmolar Nonketotic Syndrome
|
0.05%
3/6113 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.08%
5/6113 • Number of events 6 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.13%
4/3057 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.18%
11/6113 • Number of events 11 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.20%
6/3057 • Number of events 7 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.10%
6/6113 • Number of events 6 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Metabolism and nutrition disorders
Metabolic Acidosis
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.10%
3/3057 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Metabolism and nutrition disorders
Obesity
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Metabolism and nutrition disorders
Type 1 Diabetes Mellitus
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Ankylosing Spondylitis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.16%
10/6113 • Number of events 10 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.13%
4/3057 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Arthrofibrosis
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.13%
8/6113 • Number of events 9 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.26%
8/3057 • Number of events 10 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.05%
3/6113 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Cervical Spinal Stenosis
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Chondropathy
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Chronic Recurrent Multifocal Osteomyelitis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Collagen Disorder
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Foot Deformity
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Fracture Nonunion
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Gouty Arthritis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Degeneration
|
0.05%
3/6113 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Disorder
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.07%
4/6113 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.10%
3/3057 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Joint Instability
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
|
0.07%
4/6113 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Mobility Decreased
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Muscle Necrosis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.08%
5/6113 • Number of events 5 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.77%
47/6113 • Number of events 51 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.62%
19/3057 • Number of events 19 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.05%
3/6113 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Pseudarthrosis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic Arthropathy
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Syndrome
|
0.07%
4/6113 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Spinal Column Stenosis
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Spinal Osteoarthritis
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Abdominal Neoplasm
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma Gastric
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma Of Colon
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma Pancreas
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal Adenoma
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Bone Neoplasm
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer
|
0.05%
3/6113 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Neoplasm
|
0.05%
3/6113 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Transitional Cell Carcinoma Recurrent
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Transitional Cell Carcinoma Stage Ii
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone Cancer
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain Cancer Metastatic
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain Neoplasm
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain Neoplasm Malignant
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.07%
4/6113 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer Metastatic
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer Stage Ii
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Neoplasm
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial Carcinoma
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Burkitt's Lymphoma
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid Tumour Of The Duodenum
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix Carcinoma
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix Carcinoma Recurrent
|
0.02%
1/6113 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix Carcinoma Stage I
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic Lymphocytic Leukaemia
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear Cell Renal Cell Carcinoma
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Adenoma
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.03%
2/6113 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Neoplasm
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse Large B-Cell Lymphoma
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial Adenocarcinoma
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial Cancer
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Eyelid Tumour
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder Adenocarcinoma
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Adenoma
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Neoplasm
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal Carcinoma
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal Neoplasm
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal Stromal Tumour
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma Multiforme
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic Cancer
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular Carcinoma
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal Papillary Mucinous Neoplasm
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kaposi's Sarcoma
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyosarcoma
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.02%
1/6113 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Adenocarcinoma
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Cancer Metastatic
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Carcinoma Cell Type Unspecified Recurrent
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Carcinoma Cell Type Unspecified Stage Iv
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm
|
0.02%
1/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.05%
3/6113 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Neoplasm Of Eye
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Neoplasm Of Renal Pelvis
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Pleural Effusion
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Respiratory Tract Neoplasm
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mantle Cell Lymphoma
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mediastinum Neoplasm
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Central Nervous System
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Lung
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Carcinoma Of The Bladder
|
0.03%
2/6113 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Neoplasm
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm Malignant
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm Of Thymus
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm Prostate
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine Tumour
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nodal Marginal Zone B-Cell Lymphoma
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Small Cell Lung Cancer
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Small Cell Lung Cancer Recurrent
|
0.02%
1/6113 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal Carcinoma
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Cancer
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Epithelial Cancer
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Carcinoma
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Carcinoma Metastatic
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Neuroendocrine Tumour
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary Thyroid Cancer
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid Tumour Benign
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma Cell Myeloma
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.28%
17/6113 • Number of events 17 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.10%
3/3057 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer Metastatic
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Adenocarcinoma
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Cancer
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cell Carcinoma
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Neoplasm
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Retroperitoneal Cancer
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary Gland Adenoma
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary Gland Cancer
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small Cell Lung Cancer
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small Intestine Carcinoma
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Superficial Spreading Melanoma Stage Unspecified
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testicular Neoplasm
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional Cell Carcinoma
|
0.05%
3/6113 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Cancer
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Altered State Of Consciousness
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Apallic Syndrome
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Arachnoid Cyst
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Ataxia
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Brain Stem Stroke
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Carotid Arteriosclerosis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Carpal Tunnel Syndrome
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Cerebral Artery Stenosis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.07%
4/6113 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Cerebral Infarction
|
0.08%
5/6113 • Number of events 5 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.23%
7/3057 • Number of events 7 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Cerebral Ischaemia
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Cerebral Thrombosis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.31%
19/6113 • Number of events 20 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.26%
8/3057 • Number of events 8 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Cerebrovascular Disorder
|
0.05%
3/6113 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.10%
3/3057 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Cervical Myelopathy
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Cervicobrachial Syndrome
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Chronic Inflammatory Demyelinating Polyradiculoneuropathy
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Convulsion
|
0.18%
11/6113 • Number of events 15 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.29%
9/3057 • Number of events 22 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Critical Illness Polyneuropathy
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Dementia
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Dementia Alzheimer's Type
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Dementia With Lewy Bodies
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Diabetic Neuropathy
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Dizziness
|
0.07%
4/6113 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.13%
4/3057 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Dizziness Postural
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Embolic Stroke
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Encephalopathy
|
0.08%
5/6113 • Number of events 5 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.13%
4/3057 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Epilepsy
|
0.03%
2/6113 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Facial Paresis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Haemorrhage Intracranial
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Haemorrhagic Stroke
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Headache
|
0.05%
3/6113 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Hemiplegic Migraine
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Hepatic Encephalopathy
|
0.03%
2/6113 • Number of events 6 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.13%
4/3057 • Number of events 7 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Hydrocephalus
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Hypertensive Encephalopathy
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Hypoaesthesia
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Hypoglycaemic Encephalopathy
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Hypoxic-Ischaemic Encephalopathy
|
0.05%
3/6113 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Intercostal Neuralgia
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Intracranial Aneurysm
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Intracranial Pressure Increased
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Ischaemic Cerebral Infarction
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Ischaemic Stroke
|
0.18%
11/6113 • Number of events 13 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.16%
5/3057 • Number of events 5 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Lacunar Infarction
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Lumbar Radiculopathy
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Metabolic Encephalopathy
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Migraine
|
0.05%
3/6113 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Normal Pressure Hydrocephalus
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Paraesthesia
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Partial Seizures
|
0.02%
1/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Pneumocephalus
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Polyneuropathy
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Post-Traumatic Headache
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Presyncope
|
0.05%
3/6113 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Radicular Pain
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Radicular Syndrome
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Spinal Cord Compression
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Status Epilepticus
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Subarachnoid Haemorrhage
|
0.05%
3/6113 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Syncope
|
0.23%
14/6113 • Number of events 15 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.29%
9/3057 • Number of events 9 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Tension Headache
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Thalamus Haemorrhage
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Toxic Encephalopathy
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Transient Global Amnesia
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.34%
21/6113 • Number of events 21 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.26%
8/3057 • Number of events 8 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Tremor
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Trigeminal Neuralgia
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Vertebrobasilar Insufficiency
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Vertigo Cns Origin
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Vocal Cord Paralysis
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Psychiatric disorders
Alcohol Abuse
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Psychiatric disorders
Alcohol Withdrawal Syndrome
|
0.03%
2/6113 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Psychiatric disorders
Completed Suicide
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Psychiatric disorders
Conversion Disorder
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Psychiatric disorders
Delirium
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.13%
4/3057 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Psychiatric disorders
Depression
|
0.07%
4/6113 • Number of events 5 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Psychiatric disorders
Drug Dependence
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Psychiatric disorders
Impaired Self-Care
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Psychiatric disorders
Major Depression
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Psychiatric disorders
Mental Disorder
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Psychiatric disorders
Mental Status Changes
|
0.07%
4/6113 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.16%
5/3057 • Number of events 5 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Psychiatric disorders
Panic Attack
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Psychiatric disorders
Psychotic Disorder
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Psychiatric disorders
Schizoaffective Disorder
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Psychiatric disorders
Schizophrenia
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.10%
3/3057 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Psychiatric disorders
Suicide Attempt
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Renal and urinary disorders
Azotaemia
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Renal and urinary disorders
Bladder Mass
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Renal and urinary disorders
Bladder Neck Obstruction
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Renal and urinary disorders
Bladder Outlet Obstruction
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Renal and urinary disorders
Calculus Ureteric
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Renal and urinary disorders
Calculus Urinary
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Renal and urinary disorders
Cystitis Interstitial
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Renal and urinary disorders
Diabetic Nephropathy
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Renal and urinary disorders
Haematuria
|
0.13%
8/6113 • Number of events 8 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.20%
6/3057 • Number of events 7 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.07%
4/6113 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Renal and urinary disorders
Lupus Nephritis
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Renal and urinary disorders
Micturition Disorder
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.15%
9/6113 • Number of events 10 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Renal and urinary disorders
Nephrotic Syndrome
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Renal and urinary disorders
Obstructive Uropathy
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Renal and urinary disorders
Proteinuria
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Renal and urinary disorders
Renal Failure
|
0.11%
7/6113 • Number of events 8 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.10%
3/3057 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.51%
31/6113 • Number of events 35 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.26%
8/3057 • Number of events 9 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Renal and urinary disorders
Renal Failure Chronic
|
0.28%
17/6113 • Number of events 19 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.10%
3/3057 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Renal and urinary disorders
Renal Haemorrhage
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Renal and urinary disorders
Renal Impairment
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Renal and urinary disorders
Renal Injury
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Renal and urinary disorders
Renal Tubular Necrosis
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Renal and urinary disorders
Strangury
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Renal and urinary disorders
Stress Urinary Incontinence
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Renal and urinary disorders
Tubulointerstitial Nephritis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Renal and urinary disorders
Ureteric Stenosis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Renal and urinary disorders
Urethral Stenosis
|
0.11%
7/6113 • Number of events 8 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.20%
6/3057 • Number of events 9 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.05%
3/6113 • Number of events 5 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Renal and urinary disorders
Urinary Retention
|
0.08%
5/6113 • Number of events 8 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Renal and urinary disorders
Urinoma
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Renal and urinary disorders
Vesicocutaneous Fistula
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.13%
8/6113 • Number of events 8 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.16%
5/3057 • Number of events 5 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Reproductive system and breast disorders
Breast Enlargement
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Reproductive system and breast disorders
Epididymitis
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Reproductive system and breast disorders
Female Genital Tract Fistula
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Reproductive system and breast disorders
Genital Prolapse
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Reproductive system and breast disorders
Ovarian Cyst
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Reproductive system and breast disorders
Postmenopausal Haemorrhage
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Reproductive system and breast disorders
Uterine Haemorrhage
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Reproductive system and breast disorders
Vaginal Haemorrhage
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Reproductive system and breast disorders
Vaginal Prolapse
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema
|
0.05%
3/6113 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
0.07%
4/6113 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.38%
23/6113 • Number of events 29 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.33%
10/3057 • Number of events 12 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis Allergic
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.29%
18/6113 • Number of events 23 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.10%
3/3057 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.05%
3/6113 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis Chronic
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
1.4%
84/6113 • Number of events 121 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
1.7%
51/3057 • Number of events 71 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Respiratory Failure
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.20%
12/6113 • Number of events 15 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.49%
15/3057 • Number of events 15 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 5 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Hydropneumothorax
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic Pulmonary Fibrosis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
0.10%
6/6113 • Number of events 8 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Lung Disorder
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Lung Hernia
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal Disorder
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal Haemorrhage
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive Airways Disorder
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.34%
21/6113 • Number of events 22 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.33%
10/3057 • Number of events 11 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Aspiration
|
0.07%
4/6113 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.10%
3/3057 • Number of events 5 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.08%
5/6113 • Number of events 6 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Congestion
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.38%
23/6113 • Number of events 23 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.56%
17/3057 • Number of events 17 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Fibrosis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Microemboli
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.10%
6/6113 • Number of events 6 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.10%
3/3057 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Acidosis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Arrest
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Disorder
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.05%
3/6113 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.26%
16/6113 • Number of events 18 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.39%
12/3057 • Number of events 15 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Polyp
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep Apnoea Syndrome
|
0.07%
4/6113 • Number of events 5 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.10%
3/3057 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Status Asthmaticus
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal Stenosis
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
0.07%
4/6113 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Skin and subcutaneous tissue disorders
Diabetic Foot
|
0.39%
24/6113 • Number of events 25 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.43%
13/3057 • Number of events 14 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Skin and subcutaneous tissue disorders
Diabetic Ulcer
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Skin and subcutaneous tissue disorders
Rash Erythematous
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Skin and subcutaneous tissue disorders
Skin Necrosis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.18%
11/6113 • Number of events 12 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.23%
7/3057 • Number of events 9 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson Syndrome
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Surgical and medical procedures
Artificial Urinary Sphincter Implant
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Surgical and medical procedures
Cardiac Pacemaker Battery Replacement
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Surgical and medical procedures
Cardioversion
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Surgical and medical procedures
Cerebrospinal Fluid Drainage
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Surgical and medical procedures
Hip Arthroplasty
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Surgical and medical procedures
Incisional Drainage
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Surgical and medical procedures
Knee Arthroplasty
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Surgical and medical procedures
Knee Operation
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Surgical and medical procedures
Leg Amputation
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Surgical and medical procedures
Metatarsal Excision
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Surgical and medical procedures
Parathyroidectomy
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Surgical and medical procedures
Rehabilitation Therapy
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Surgical and medical procedures
Tooth Extraction
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Aneurysm
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Aneurysm Ruptured
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Aortic Aneurysm
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.10%
3/3057 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Aortic Aneurysm Rupture
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Aortic Stenosis
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Aortic Thrombosis
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Arterial Occlusive Disease
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Arterial Stenosis
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Arteriosclerosis
|
0.07%
4/6113 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Circulatory Collapse
|
0.02%
1/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.20%
12/6113 • Number of events 12 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.16%
5/3057 • Number of events 5 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Essential Hypertension
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Extremity Necrosis
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Femoral Artery Occlusion
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Haematoma
|
0.07%
4/6113 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Hypertension
|
0.11%
7/6113 • Number of events 7 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Hypertensive Crisis
|
0.15%
9/6113 • Number of events 9 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Hypertensive Emergency
|
0.05%
3/6113 • Number of events 3 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Hypotension
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.16%
5/3057 • Number of events 5 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Hypovolaemic Shock
|
0.07%
4/6113 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.13%
4/3057 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Infarction
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Intra-Abdominal Haematoma
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Lymphoedema
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Orthostatic Hypotension
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
0.11%
7/6113 • Number of events 8 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.13%
4/3057 • Number of events 4 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Peripheral Artery Aneurysm
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Peripheral Artery Stenosis
|
0.07%
4/6113 • Number of events 5 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Peripheral Artery Thrombosis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Peripheral Embolism
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Peripheral Ischaemia
|
0.18%
11/6113 • Number of events 15 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Peripheral Vascular Disorder
|
0.20%
12/6113 • Number of events 13 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Phlebitis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Phlebitis Deep
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Post Thrombotic Syndrome
|
0.02%
1/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Shock
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Shock Haemorrhagic
|
0.08%
5/6113 • Number of events 5 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Subclavian Artery Stenosis
|
0.00%
0/6113 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Temporal Arteritis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Thromboangiitis Obliterans
|
0.02%
1/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Thrombophlebitis Superficial
|
0.02%
1/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Varicophlebitis
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Varicose Ulceration
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.07%
2/3057 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Vascular Insufficiency
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Venous Thrombosis
|
0.03%
2/6113 • Number of events 2 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.00%
0/3057 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Vascular disorders
Venous Thrombosis Limb
|
0.02%
1/6113 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
0.03%
1/3057 • Number of events 1 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
Other adverse events
| Measure |
C. Difficile Vaccine Group
n=6113 participants at risk
Participants received 1 injection of 0.5 mL C. difficile toxoid vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).
|
Placebo Group
n=3057 participants at risk
Participants received 1 injection of 0.5 mL placebo matched to vaccine at Days 0 (Injection 1), 7 (Injection 2), and 30 (Injection 3).
|
|---|---|---|
|
General disorders
Injection Site Pain
|
14.0%
855/6113 • Number of events 1252 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
4.2%
127/3057 • Number of events 157 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
General disorders
Malaise
|
5.3%
325/6113 • Number of events 456 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
4.4%
135/3057 • Number of events 195 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
345/6113 • Number of events 481 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
4.8%
146/3057 • Number of events 205 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.0%
368/6113 • Number of events 556 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
4.3%
132/3057 • Number of events 201 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
|
|
Nervous system disorders
Headache
|
8.7%
531/6113 • Number of events 758 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
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7.5%
229/3057 • Number of events 327 • Adverse events data was collected throughout the study (up to 3 years).
Safety Analysis Set included all participants who received at least one study or control vaccine and were analyzed according to the vaccine received. Solicited reaction(SR) was an adverse event (AE) that was prelisted (i.e.,solicited) in the electronic case report form (eCRF) and considered to be related to vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e.,solicited) in the eCRF in terms of symptom and/or onset post-vaccination.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
- Publication restrictions are in place
Restriction type: OTHER