Trial Outcomes & Findings for VA-008 ACAM2000® Vaccination of Plasma Donors for the Production of VIGIV (NCT NCT02443623)

NCT ID: NCT02443623

Last Updated: 2024-03-18

Results Overview

Number of subjects with AEs including SAEs up to 90 days after vaccination.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 3032 participants
• Primary outcome timeframe: Adverse event data was collected from vaccinated participants through Day 90.
• Results posted on: 2024-03-18

Participant Flow

Participant milestones

Measure	Single Arm Vaccinated With ACAM2000 Healthy adult male and female volunteers who met the requirements for source plasma donation and study entry criteria were vaccinated with the ACAM2000 smallpox vaccine for collection of plasma to be used in the manufacture of VIGIV. There are possible risks associated with ACAM2000 vaccination. To ensure the safety of plasma donors, risk factor screening procedures and the collection of post-vaccination safety data were assessed throughout the study.
Overall Study STARTED	3032
Overall Study COMPLETED	2788
Overall Study NOT COMPLETED	244

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

VA-008 ACAM2000® Vaccination of Plasma Donors for the Production of VIGIV

Baseline characteristics by cohort

Measure	Single Arm Vaccinated With ACAM2000 n=3032 Participants Healthy adult male and female volunteers who met the requirements for source plasma donation and study entry criteria were vaccinated with the ACAM2000 smallpox vaccine for collection of plasma used in the manufacture of VIGIV.
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3013 Participants n=5 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants
Sex: Female, Male Female	765 Participants n=5 Participants
Sex: Female, Male Male	2267 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	626 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2325 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	81 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	64 Participants n=5 Participants
Race (NIH/OMB) Asian	25 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	13 Participants n=5 Participants
Race (NIH/OMB) Black or African American	744 Participants n=5 Participants
Race (NIH/OMB) White	2123 Participants n=5 Participants
Race (NIH/OMB) More than one race	27 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	36 Participants n=5 Participants
Region of Enrollment United States	3032 participants n=5 Participants
Height	174.3 cm STANDARD_DEVIATION 9.5 • n=5 Participants
Weight	92.5 kg STANDARD_DEVIATION 20.4 • n=5 Participants
BMI	30.4 kg/m^2 STANDARD_DEVIATION 6.4 • n=5 Participants

PRIMARY outcome

Timeframe: Adverse event data was collected from vaccinated participants through Day 90.

Population: The safety population consisted of 3032 participants who were vaccinated, including 208 participants who were vaccinated twice (n= 208 includes two participants who were inadvertently vaccinated twice and were included twice in demography and all participant counts).

Number of subjects with AEs including SAEs up to 90 days after vaccination.

Outcome measures

Measure	Single Arm Vaccinated With ACAM2000 n=3032 Participants Healthy adult male and female volunteers who met the requirements for source plasma donation and study entry criteria were vaccinated with the ACAM2000 smallpox vaccine for collection of plasma used in the manufacture of VIGIV.
Number of Vaccinated Participants With Adverse Events (AEs) Including Serious Adverse Events (SAEs)	1420 Participants

PRIMARY outcome

Timeframe: Adverse event data was collected from vaccinated participants through Day 90.

Population: The safety population consisted of 3032 participants who were vaccinated, including 208 participants who were vaccinated twice (n= 208 includes two participants who were inadvertently vaccinated twice and were included twice in demography and all participant counts).

Number of subjects with related AEs up to 90 days after vaccination.

Outcome measures

Measure	Single Arm Vaccinated With ACAM2000 n=3032 Participants Healthy adult male and female volunteers who met the requirements for source plasma donation and study entry criteria were vaccinated with the ACAM2000 smallpox vaccine for collection of plasma used in the manufacture of VIGIV.
Number of Vaccinated Participants With Related Adverse Events	1190 Participants

PRIMARY outcome

Timeframe: Adverse event data was collected from vaccinated participants through Day 90.

Population: The safety population consisted of 3032 participants who were vaccinated, including 208 participants who were vaccinated twice (n= 208 includes two participants who were inadvertently vaccinated twice and were included twice in demography and all participant counts).

Number of subjects with SAEs up to 90 days after vaccination.

Outcome measures

Measure	Single Arm Vaccinated With ACAM2000 n=3032 Participants Healthy adult male and female volunteers who met the requirements for source plasma donation and study entry criteria were vaccinated with the ACAM2000 smallpox vaccine for collection of plasma used in the manufacture of VIGIV.
Number of Vaccinated Participants With Serious Adverse Events (SAEs)	25 Participants

Adverse Events

Single Arm Vaccinated With ACAM2000 With AEs

Serious events: 25 serious events

Other events: 1413 other events

Deaths: 1 deaths

Single Arm Vaccinated With ACAM2000 With Related AEs

Serious events: 0 serious events

Other events: 1190 other events

Deaths: 0 deaths

Serious adverse events

Measure	Single Arm Vaccinated With ACAM2000 With AEs n=3032 participants at risk Healthy adult male and female volunteers who met the requirements for source plasma donation and study entry criteria were vaccinated with the ACAM2000 smallpox vaccine for collection of plasma used in the manufacture of VIGIV.	Single Arm Vaccinated With ACAM2000 With Related AEs n=3032 participants at risk Healthy adult male and female volunteers who met the requirements for source plasma donation and study entry criteria were vaccinated with the ACAM2000 smallpox vaccine for collection of plasma used in the manufacture of VIGIV with related adverse events.
Immune system disorders Hypersensitivity	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	— 0/0 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Cardiac disorders Acute coronary syndrome	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	— 0/0 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Cardiac disorders Acute myocardial infarction	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	— 0/0 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Cardiac disorders Angina pectoris	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	— 0/0 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
General disorders Chest pain	0.07% 2/3032 • Number of events 2 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	— 0/0 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
General disorders Non-cardiac chest pain	0.07% 2/3032 • Number of events 2 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	— 0/0 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Infections and infestations Appendicitis	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	— 0/0 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Infections and infestations Peritonsillar abscess	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	— 0/0 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Infections and infestations Post vaccination autoinoculation	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	— 0/0 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Infections and infestations Upper respiratory tract infection	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	— 0/0 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Injury, poisoning and procedural complications Alcohol poisoning	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	— 0/0 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Injury, poisoning and procedural complications Arthropod bite	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	— 0/0 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Injury, poisoning and procedural complications Back injury	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	— 0/0 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Injury, poisoning and procedural complications Head injury	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	— 0/0 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Injury, poisoning and procedural complications Subdural haematoma	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	— 0/0 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Metabolism and nutrition disorders Hyperglycaemia	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	— 0/0 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Metabolism and nutrition disorders Hypokalaemia	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	— 0/0 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	— 0/0 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	— 0/0 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Nervous system disorders Alcoholic seizure	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	— 0/0 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Nervous system disorders Ischaemic stroke	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	— 0/0 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Nervous system disorders Subarachnoid haemorrhage	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	— 0/0 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Nervous system disorders Syncope	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	— 0/0 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Psychiatric disorders Alcohol withdrawal syndrome	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	— 0/0 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Psychiatric disorders Bipolar disorder	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	— 0/0 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Psychiatric disorders Post-traumatic stress disorder	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	— 0/0 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	— 0/0 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	— 0/0 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	— 0/0 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.07% 2/3032 • Number of events 2 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	— 0/0 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.

Other adverse events

Measure	Single Arm Vaccinated With ACAM2000 With AEs n=3032 participants at risk Healthy adult male and female volunteers who met the requirements for source plasma donation and study entry criteria were vaccinated with the ACAM2000 smallpox vaccine for collection of plasma used in the manufacture of VIGIV.	Single Arm Vaccinated With ACAM2000 With Related AEs n=3032 participants at risk Healthy adult male and female volunteers who met the requirements for source plasma donation and study entry criteria were vaccinated with the ACAM2000 smallpox vaccine for collection of plasma used in the manufacture of VIGIV with related adverse events.
General disorders Vaccination site pain	1.5% 46/3032 • Number of events 47 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	1.4% 43/3032 • Number of events 44 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Blood and lymphatic system disorders Lymphadenopathy	0.33% 10/3032 • Number of events 12 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.26% 8/3032 • Number of events 9 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Cardiac disorders Atrial fibrillation	0.03% 1/3032 • Number of events 2 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Cardiac disorders Bradycardia	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Cardiac disorders Palpitations	0.16% 5/3032 • Number of events 5 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Cardiac disorders Tachycardia	0.13% 4/3032 • Number of events 4 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Cardiac disorders Ventricular extrasystoles	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Ear and labyrinth disorders Deafness neurosensory	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Ear and labyrinth disorders Ear discomort	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Ear and labyrinth disorders Ear pain	0.13% 4/3032 • Number of events 4 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Ear and labyrinth disorders Eustachian tube obstruction	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Endocrine disorders Hypothyroidism	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Eye disorders Abnormal sensation in eye	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Eye disorders Eye irritation	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Eye disorders Eye pain	0.03% 1/3032 • Number of events 2 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Eye disorders Eye pruritus	0.10% 3/3032 • Number of events 4 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Eye disorders Eye swelling	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Eye disorders Lacrimation increased	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Eye disorders Photophobia	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Eye disorders Scleral hemorrhage	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Eye disorders Vision blurred	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Gastrointestinal disorders Abdominal discomfort	0.20% 6/3032 • Number of events 6 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Gastrointestinal disorders Abdominal pain	0.10% 3/3032 • Number of events 3 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Gastrointestinal disorders Abdominal pain upper	0.23% 7/3032 • Number of events 9 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Gastrointestinal disorders Aphthous ulcer	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Gastrointestinal disorders Chapped lips	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Gastrointestinal disorders Constipation	0.07% 2/3032 • Number of events 2 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Gastrointestinal disorders Diarrhea	0.79% 24/3032 • Number of events 24 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.10% 3/3032 • Number of events 3 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Gastrointestinal disorders Dry mouth	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Gastrointestinal disorders Dyspepsia	0.20% 6/3032 • Number of events 6 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Gastrointestinal disorders Dysphagia	0.07% 2/3032 • Number of events 2 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Gastrointestinal disorders Flatulence	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Gastrointestinal disorders Food poisoning	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Gastrointestinal disorders Gastritis	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Gastrointestinal disorders Gastrointestinal pain	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Gastrointestinal disorders Gastroesophageal reflux disease	0.13% 4/3032 • Number of events 4 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Gastrointestinal disorders Gingival bleeding	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Gastrointestinal disorders Nausea	1.1% 34/3032 • Number of events 37 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.26% 8/3032 • Number of events 8 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Gastrointestinal disorders Oral disorder	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Gastrointestinal disorders Toothache	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Gastrointestinal disorders Vomiting	0.59% 18/3032 • Number of events 18 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.13% 4/3032 • Number of events 4 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
General disorders Asthenia	0.20% 6/3032 • Number of events 6 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.13% 4/3032 • Number of events 4 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
General disorders Axillary pain	0.23% 7/3032 • Number of events 8 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.16% 5/3032 • Number of events 5 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
General disorders Chest discomfort	0.33% 10/3032 • Number of events 11 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.10% 3/3032 • Number of events 3 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
General disorders Chest pain	0.43% 13/3032 • Number of events 14 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
General disorders Chills	0.40% 12/3032 • Number of events 12 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.20% 6/3032 • Number of events 6 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
General disorders Fatigue	1.6% 48/3032 • Number of events 53 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.49% 15/3032 • Number of events 15 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
General disorders Hypothermia	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
General disorders Influenza like illness	0.49% 15/3032 • Number of events 17 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
General disorders Infusion site hypoaesthesia	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
General disorders Injection site bruising	0.07% 2/3032 • Number of events 2 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
General disorders Injection site scab	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
General disorders Malaise	0.07% 2/3032 • Number of events 2 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
General disorders Non-cardiac chest pain	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
General disorders Oedema	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
General disorders Oedema peripheral	0.10% 3/3032 • Number of events 3 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
General disorders Pain	0.76% 23/3032 • Number of events 23 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.36% 11/3032 • Number of events 11 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
General disorders Peripheral swelling	0.07% 2/3032 • Number of events 2 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
General disorders Pyrexia	1.8% 56/3032 • Number of events 59 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	1.1% 32/3032 • Number of events 34 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
General disorders Swelling	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
General disorders Vaccination site bruising	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
General disorders Vaccination site discharge	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
General disorders Vaccination site discomfort	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
General disorders Vaccinatination site erythema	0.07% 2/3032 • Number of events 2 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.07% 2/3032 • Number of events 2 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
General disorders Vaccination site injury	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
General disorders Vaccination site irritation	0.10% 3/3032 • Number of events 3 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.10% 3/3032 • Number of events 3 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
General disorders Vaccination site joint erythema	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
General disorders Vaccination site pruritus	0.73% 22/3032 • Number of events 22 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.69% 21/3032 • Number of events 21 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
General disorders Vaccination site rash	0.07% 2/3032 • Number of events 2 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.07% 2/3032 • Number of events 2 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
General disorders Vaccination site reaction	0.13% 4/3032 • Number of events 4 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.13% 4/3032 • Number of events 4 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
General disorders Vaccination site scab	36.2% 1098/3032 • Number of events 1103 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	35.9% 1089/3032 • Number of events 1094 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
General disorders Vaccination site streaking	0.10% 3/3032 • Number of events 3 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.10% 3/3032 • Number of events 3 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
General disorders Vaccination site swelling	0.10% 3/3032 • Number of events 3 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.10% 3/3032 • Number of events 3 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
General disorders Vaccination site warmth	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Immune system disorders Seasonal allergy	0.43% 13/3032 • Number of events 15 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Immune system disorders Smoke sensitivity	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Infections and infestations Abscess	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Infections and infestations Bronchitis	0.10% 3/3032 • Number of events 3 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Infections and infestations COVID-19	0.07% 2/3032 • Number of events 2 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Infections and infestations Conjunctivitis	0.10% 3/3032 • Number of events 3 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Infections and infestations Ear infection	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Infections and infestations Gastroenteritis viral	0.07% 2/3032 • Number of events 2 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Infections and infestations Herpes simplex	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Infections and infestations Influenza	0.13% 4/3032 • Number of events 4 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Infections and infestations Injection site abscess	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Infections and infestations Laryngitis	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Infections and infestations Lower respiratory tract infection	0.07% 2/3032 • Number of events 2 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Infections and infestations Nasopharyngitis	0.69% 21/3032 • Number of events 22 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.07% 2/3032 • Number of events 2 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Infections and infestations Ophthalmic herpes simplex	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Infections and infestations Oral herpes	0.07% 2/3032 • Number of events 2 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Infections and infestations Post vaccination autoinoculation	0.16% 5/3032 • Number of events 5 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.16% 5/3032 • Number of events 5 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Infections and infestations Respiratory tract infection	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Infections and infestations Sinusitis	0.07% 2/3032 • Number of events 2 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Infections and infestations Syphilis	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Infections and infestations Tinea cruris	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Infections and infestations Tinea pedis	0.07% 2/3032 • Number of events 2 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Infections and infestations Tooth infection	0.07% 2/3032 • Number of events 2 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Infections and infestations Upper respiratory tract infection	0.07% 2/3032 • Number of events 2 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Infections and infestations Urinary tract infection	0.16% 5/3032 • Number of events 5 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Infections and infestations Vaccination site infection	0.07% 2/3032 • Number of events 2 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.07% 2/3032 • Number of events 2 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Infections and infestations Viral supper respiratory tract infection	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Injury, poisoning and procedural complications Alcohol poisoning	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Injury, poisoning and procedural complications Arthropod bite	0.10% 3/3032 • Number of events 3 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Injury, poisoning and procedural complications Burns first degree	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Injury, poisoning and procedural complications Contusion	0.10% 3/3032 • Number of events 3 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Injury, poisoning and procedural complications Eye contusion	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Injury, poisoning and procedural complications Fall	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Injury, poisoning and procedural complications Fibula fracture	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Injury, poisoning and procedural complications Foot fracture	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Injury, poisoning and procedural complications Fractured coccyx	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Injury, poisoning and procedural complications Joint injury	0.07% 2/3032 • Number of events 2 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Injury, poisoning and procedural complications Ligament injury	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Injury, poisoning and procedural complications Ligament sprain	0.20% 6/3032 • Number of events 6 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Injury, poisoning and procedural complications Limb injury	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Injury, poisoning and procedural complications Muscle strain	0.07% 2/3032 • Number of events 2 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Injury, poisoning and procedural complications Skin abrasion	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Injury, poisoning and procedural complications Skin laceration	0.13% 4/3032 • Number of events 5 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Injury, poisoning and procedural complications Thermal burn	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Injury, poisoning and procedural complications Tooth fracture	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Injury, poisoning and procedural complications Upper limb fracture	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Injury, poisoning and procedural complications Vaccination complication	0.30% 9/3032 • Number of events 10 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.30% 9/3032 • Number of events 10 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Injury, poisoning and procedural complications Wound	0.26% 8/3032 • Number of events 8 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.10% 3/3032 • Number of events 3 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Investigations Blood cholesterol increased	0.10% 3/3032 • Number of events 3 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Investigations Blood potassium decreased	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Investigations Blood pressure increased	0.10% 3/3032 • Number of events 3 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Investigations Body temperature decreased	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Investigations Body temperature increased	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Investigations HIV test positive	0.07% 2/3032 • Number of events 2 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Investigations Heart rate decreased	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Investigations Heart rate increased	0.10% 3/3032 • Number of events 3 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Investigations Heart rate irregular	0.10% 3/3032 • Number of events 4 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Investigations Hepatitis C virus test positive	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Investigations Treponema test positive	0.20% 6/3032 • Number of events 6 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Metabolism and nutrition disorders Appetite disorder	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Metabolism and nutrition disorders Decreased appetite	0.13% 4/3032 • Number of events 4 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Metabolism and nutrition disorders Dehydration	0.13% 4/3032 • Number of events 5 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Metabolism and nutrition disorders Gout	0.07% 2/3032 • Number of events 2 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Metabolism and nutrition disorders Hyperglycemia	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Metabolism and nutrition disorders Vitamin D deficiency	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Musculoskeletal and connective tissue disorders Arthralgia	0.66% 20/3032 • Number of events 28 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.10% 3/3032 • Number of events 3 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Musculoskeletal and connective tissue disorders Arthritis	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Musculoskeletal and connective tissue disorders Back pain	0.43% 13/3032 • Number of events 13 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Musculoskeletal and connective tissue disorders Costochondritis	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Musculoskeletal and connective tissue disorders Facial bone fracture	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Musculoskeletal and connective tissue disorders Joint swelling	0.10% 3/3032 • Number of events 3 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Musculoskeletal and connective tissue disorders Medial tibial stress syndrome	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Musculoskeletal and connective tissue disorders Muscle spasms	0.26% 8/3032 • Number of events 12 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Musculoskeletal and connective tissue disorders Muscle tightness	0.07% 2/3032 • Number of events 2 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.07% 2/3032 • Number of events 3 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.13% 4/3032 • Number of events 4 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Musculoskeletal and connective tissue disorders Myalgia	0.56% 17/3032 • Number of events 20 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.13% 4/3032 • Number of events 4 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Musculoskeletal and connective tissue disorders Neck pain	0.26% 8/3032 • Number of events 8 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.10% 3/3032 • Number of events 3 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Musculoskeletal and connective tissue disorders Pain in extremity	0.40% 12/3032 • Number of events 12 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.10% 3/3032 • Number of events 3 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Musculoskeletal and connective tissue disorders Pain in jaw	0.07% 2/3032 • Number of events 3 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Nervous system disorders Amnesia	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Nervous system disorders Balance disorder	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Nervous system disorders Dizziness	0.59% 18/3032 • Number of events 18 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.16% 5/3032 • Number of events 5 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Nervous system disorders Dysgeusia	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Nervous system disorders Formication	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Nervous system disorders Headache	6.0% 182/3032 • Number of events 242 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	1.9% 58/3032 • Number of events 63 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Nervous system disorders Hypoesthesia	0.07% 2/3032 • Number of events 3 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Nervous system disorders Lethargy	0.07% 2/3032 • Number of events 2 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Nervous system disorders Migraine	0.20% 6/3032 • Number of events 7 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Nervous system disorders Nerve compression	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Nervous system disorders Paresthesia	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Nervous system disorders Sinus headache	0.07% 2/3032 • Number of events 2 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Nervous system disorders Somnolence	0.10% 3/3032 • Number of events 3 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.07% 2/3032 • Number of events 2 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Nervous system disorders Syncope	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Nervous system disorders Tension headache	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Nervous system disorders Tremor	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Psychiatric disorders Affect liability	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Psychiatric disorders Anxiety	0.13% 4/3032 • Number of events 4 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Psychiatric disorders Confusional state	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Psychiatric disorders Delirium tremens	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Psychiatric disorders Depression	0.16% 5/3032 • Number of events 5 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Psychiatric disorders Disorientation	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Psychiatric disorders Hallucination	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Psychiatric disorders Insomnia	0.16% 5/3032 • Number of events 5 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Psychiatric disorders Irritability	0.16% 5/3032 • Number of events 5 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Psychiatric disorders Nightmare	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Psychiatric disorders Restlessness	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Psychiatric disorders Sleep disorder	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Renal and urinary disorders Acute kidney injury	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Renal and urinary disorders Chromaturia	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Renal and urinary disorders Micturition urgency	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Renal and urinary disorders Nephrolithiasis	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Renal and urinary disorders Pollakiuria	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Renal and urinary disorders Polyuria	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Renal and urinary disorders Urine abnormality	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Reproductive system and breast disorders Dysmenorrhea	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Reproductive system and breast disorders Erectile dysfunction	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Reproductive system and breast disorders Menorrhagia	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Reproductive system and breast disorders Premenstrual syndrome	0.03% 1/3032 • Number of events 2 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Reproductive system and breast disorders Testicular pain	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Respiratory, thoracic and mediastinal disorders Asthma	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Respiratory, thoracic and mediastinal disorders Cough	1.5% 45/3032 • Number of events 50 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.23% 7/3032 • Number of events 8 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Respiratory, thoracic and mediastinal disorders Dry throat	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.66% 20/3032 • Number of events 21 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.16% 5/3032 • Number of events 5 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Respiratory, thoracic and mediastinal disorders Dyspnea exertional	0.07% 2/3032 • Number of events 2 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.43% 13/3032 • Number of events 14 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.73% 22/3032 • Number of events 24 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.07% 2/3032 • Number of events 2 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Respiratory, thoracic and mediastinal disorders Paranasal sinus discomfort	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Respiratory, thoracic and mediastinal disorders Pharyngeal swelling	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Respiratory, thoracic and mediastinal disorders Productive cough	0.33% 10/3032 • Number of events 12 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	0.23% 7/3032 • Number of events 7 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	0.59% 18/3032 • Number of events 19 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 2 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.13% 4/3032 • Number of events 4 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Respiratory, thoracic and mediastinal disorders Sinus disorder	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Respiratory, thoracic and mediastinal disorders Sinus pain	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.13% 4/3032 • Number of events 4 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.07% 2/3032 • Number of events 2 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Respiratory, thoracic and mediastinal disorders Throat tightness	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Respiratory, thoracic and mediastinal disorders Wheezing	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Skin and subcutaneous tissue disorders Acne	0.13% 4/3032 • Number of events 4 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Skin and subcutaneous tissue disorders Application site acne	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Skin and subcutaneous tissue disorders Blister	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Skin and subcutaneous tissue disorders Blood blister	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Skin and subcutaneous tissue disorders Cold sweat	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Skin and subcutaneous tissue disorders Dermatitis	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Skin and subcutaneous tissue disorders Dermatitis contact	0.20% 6/3032 • Number of events 7 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.07% 2/3032 • Number of events 2 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Skin and subcutaneous tissue disorders Erythema	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Skin and subcutaneous tissue disorders Hyperhydrosis	0.10% 3/3032 • Number of events 3 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Skin and subcutaneous tissue disorders Night sweats	0.10% 3/3032 • Number of events 3 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.10% 3/3032 • Number of events 3 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Skin and subcutaneous tissue disorders Pityriasis rosea	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Skin and subcutaneous tissue disorders Pruritus	0.26% 8/3032 • Number of events 9 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.13% 4/3032 • Number of events 5 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Skin and subcutaneous tissue disorders Rash	0.30% 9/3032 • Number of events 9 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.10% 3/3032 • Number of events 3 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Skin and subcutaneous tissue disorders Rash pruritic	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Skin and subcutaneous tissue disorders Scab	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Skin and subcutaneous tissue disorders Skin irritation	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Skin and subcutaneous tissue disorders Skin lesion	0.03% 1/3032 • Number of events 2 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 2 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Skin and subcutaneous tissue disorders Skin mass	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Skin and subcutaneous tissue disorders Urticaria	0.10% 3/3032 • Number of events 3 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.07% 2/3032 • Number of events 2 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Skin and subcutaneous tissue disorders Yellow skin	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Surgical and medical procedures Joint arthroplasty	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Surgical and medical procedures Knee operation	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Surgical and medical procedures Ovarian cystectomy	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Surgical and medical procedures Sinus operation	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Surgical and medical procedures Tooth extraction	0.10% 3/3032 • Number of events 3 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Surgical and medical procedures Vasectomy	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Vascular disorders Hot flush	0.16% 5/3032 • Number of events 5 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Vascular disorders Hypertension	0.30% 9/3032 • Number of events 9 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Vascular disorders Hypotension	0.10% 3/3032 • Number of events 3 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.
Vascular disorders Peripheral coldness	0.03% 1/3032 • Number of events 1 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.	0.00% 0/3032 • Adverse event data was collected from vaccinated participants through Day 90. All AEs were elicited by the PI. The causality of an AE was determined by the PI. Diary cards were utilized to help subjects record and track AEs between study assessments. All AEs/reactions on diary cards were reviewed with subjects by the PI and/or designate at the regularly scheduled visits. AEs from the diary card were entered into the data capture (EDC) system. Related AEs are reported under Other (Not Including Serious) AEs;related events were not reported for All-Cause Mortality and SAEs.

Additional Information

Clinical Development Representative

Emergent Biosolutions Inc.

Phone: (204) 275-4196

Email: ctgov@ebsi.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60