Trial Outcomes & Findings for Drug Use Investigation of COMIRNATY Intramuscular Injection (NCT NCT04815031)
NCT ID: NCT04815031
Last Updated: 2024-11-27
Results Overview
A serious adverse event was any untoward medical occurrence resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; or congenital anomaly.
Recruitment status
COMPLETED
Target enrollment
14570 participants
Primary outcome timeframe
From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination was 11 months, If booster vaccination was conducted, up to the day before booster vaccination.
Results posted on
2024-11-27
Participant Flow
Participant milestones
| Measure |
COMIRNATY Intramuscular Injection
The healthcare professionals who were vaccinated with this product early after the marketing approval of this product (participants in the Investigation of Health Status of Recipients Vaccinated First conducted by the Science Research Group of the Ministry of Health, Labour and Welfare) as indicated in the approved local product document were observed for a period of 11 months from the day following 28 days after the final vaccination of the initial immunization with this product to 12 months after the final vaccination of the initial immunization with this product.
If booster vaccination was not conducted, the long-term safety after the initial immunization of this product during the follow-up period was assessed.
If booster vaccination was conducted, the long-term safety after the initial immunization of this product up to the day before booster vaccination was confirmed, and information on serious adverse events and COVID-19 were continuously obtained after booster vaccination.
This study only collected serious adverse events.
|
|---|---|
|
Overall Study
STARTED
|
14570
|
|
Overall Study
Received a Booster Vaccination in Completed Paticipants.
|
13695
|
|
Overall Study
COMPLETED
|
14537
|
|
Overall Study
NOT COMPLETED
|
33
|
Reasons for withdrawal
| Measure |
COMIRNATY Intramuscular Injection
The healthcare professionals who were vaccinated with this product early after the marketing approval of this product (participants in the Investigation of Health Status of Recipients Vaccinated First conducted by the Science Research Group of the Ministry of Health, Labour and Welfare) as indicated in the approved local product document were observed for a period of 11 months from the day following 28 days after the final vaccination of the initial immunization with this product to 12 months after the final vaccination of the initial immunization with this product.
If booster vaccination was not conducted, the long-term safety after the initial immunization of this product during the follow-up period was assessed.
If booster vaccination was conducted, the long-term safety after the initial immunization of this product up to the day before booster vaccination was confirmed, and information on serious adverse events and COVID-19 were continuously obtained after booster vaccination.
This study only collected serious adverse events.
|
|---|---|
|
Overall Study
No adverse event information (missing information)
|
33
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
COMIRNATY Intramuscular Injection
n=14537 Participants
The healthcare professionals who were vaccinated with this product early after the marketing approval of this product (participants in the Investigation of Health Status of Recipients Vaccinated First conducted by the Science Research Group of the Ministry of Health, Labour and Welfare) as indicated in the approved local product document were observed for a period of 11 months from the day following 28 days after the final vaccination of the initial immunization with this product to 12 months after the final vaccination of the initial immunization with this product.
If booster vaccination was not conducted, the long-term safety after the initial immunization of this product during the follow-up period was assessed.
If booster vaccination was conducted, the long-term safety after the initial immunization of this product up to the day before booster vaccination was confirmed, and information on serious adverse events and COVID-19 were continuously obtained after booster vaccination.
This study only collected serious adverse events.
|
|---|---|
|
Age, Customized
<15 years
|
0 Participants
n=14537 Participants
|
|
Age, Customized
≥15 and <65 years
|
14113 Participants
n=14537 Participants
|
|
Age, Customized
≥65 years
|
424 Participants
n=14537 Participants
|
|
Sex: Female, Male
Female
|
9744 Participants
n=14537 Participants
|
|
Sex: Female, Male
Male
|
4793 Participants
n=14537 Participants
|
PRIMARY outcome
Timeframe: From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination was 11 months, If booster vaccination was conducted, up to the day before booster vaccination.Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and were vaccinated with COMIRNATY at least once. Participants with no adverse event information (missing information) were excluded.
A serious adverse event was any untoward medical occurrence resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; or congenital anomaly.
Outcome measures
| Measure |
COMIRNATY (Tozinameran) ; If the Booster Vaccination Was Conducted, up to the Day Before Booster
n=14537 Participants
The healthcare professionals who were vaccinated with this product early after the marketing approval of this product (participants in the Investigation of Health Status of Recipients Vaccinated First conducted by the Science Research Group of the Ministry of Health, Labour and Welfare) as indicated in the approved local product document were observed for a period of 11 months from the day following 28 days after the final vaccination of the initial immunization with this product to 12 months after the final vaccination of the initial immunization with this product.
If booster vaccination was not conducted, the long-term safety after the initial immunization of this product during the follow-up period was assessed.
If booster vaccination was conducted, the long-term safety after the initial immunization of this product up to the day before booster vaccination was confirmed, and information on serious adverse events and COVID-19 were continuously obtained after booster vaccination.
This study only collected serious adverse events.
|
|---|---|
|
Proportion of Participants With Serious Adverse Events
|
0.83 Percentage of Participants
|
PRIMARY outcome
Timeframe: From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination was 11 months, If booster vaccination was conducted, up to the day before booster vaccination.Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and were vaccinated with COMIRNATY at least once. Participants with no adverse event information (missing information) were excluded.
By using the information on COVID-19 entered in the CRF submitted by the physician, participants who were considered to be in a severe condition were identified and the number and proportion of the participants were tabulated with reference to the severity classification in the Guidance for Treatment of Novel Coronavirus Infection (COVID-19). Participants with severe COVID-19 were defined as any of the following actions taken during the period from disease onset to the outcome date: admission to an ICU; use of mechanical ventilation; or use of ECMO.
Outcome measures
| Measure |
COMIRNATY (Tozinameran) ; If the Booster Vaccination Was Conducted, up to the Day Before Booster
n=14537 Participants
The healthcare professionals who were vaccinated with this product early after the marketing approval of this product (participants in the Investigation of Health Status of Recipients Vaccinated First conducted by the Science Research Group of the Ministry of Health, Labour and Welfare) as indicated in the approved local product document were observed for a period of 11 months from the day following 28 days after the final vaccination of the initial immunization with this product to 12 months after the final vaccination of the initial immunization with this product.
If booster vaccination was not conducted, the long-term safety after the initial immunization of this product during the follow-up period was assessed.
If booster vaccination was conducted, the long-term safety after the initial immunization of this product up to the day before booster vaccination was confirmed, and information on serious adverse events and COVID-19 were continuously obtained after booster vaccination.
This study only collected serious adverse events.
|
|---|---|
|
Proportion of Participants With Severe COVID-19
|
0 Percentage of Participants
|
PRIMARY outcome
Timeframe: From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination was 11 months, If booster vaccination was conducted, up to the day before booster vaccination.Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and were vaccinated with COMIRNATY at least once. Participants with no adverse event information (missing information) were excluded.
A serious adverse reaction was any untoward medical occurrence attributed to COMIRNATY resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; or congenital anomaly. Relatedness to COMIRNATY was assessed by the physician.
Outcome measures
| Measure |
COMIRNATY (Tozinameran) ; If the Booster Vaccination Was Conducted, up to the Day Before Booster
n=14537 Participants
The healthcare professionals who were vaccinated with this product early after the marketing approval of this product (participants in the Investigation of Health Status of Recipients Vaccinated First conducted by the Science Research Group of the Ministry of Health, Labour and Welfare) as indicated in the approved local product document were observed for a period of 11 months from the day following 28 days after the final vaccination of the initial immunization with this product to 12 months after the final vaccination of the initial immunization with this product.
If booster vaccination was not conducted, the long-term safety after the initial immunization of this product during the follow-up period was assessed.
If booster vaccination was conducted, the long-term safety after the initial immunization of this product up to the day before booster vaccination was confirmed, and information on serious adverse events and COVID-19 were continuously obtained after booster vaccination.
This study only collected serious adverse events.
|
|---|---|
|
Proportion of Participants With Serious Adverse Reactions
|
0.03 Percentage of Participants
|
PRIMARY outcome
Timeframe: From the day of booster vaccination up to 11 months from the day following 28 days after the final vaccination of COMIRNATY. (out of scope of the safety evaluation)Population: Participants who received booster vaccination regardless of COMIRNATY or other COVID-19 vaccines
A serious adverse event was any untoward medical occurrence resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; or congenital anomaly.
Outcome measures
| Measure |
COMIRNATY (Tozinameran) ; If the Booster Vaccination Was Conducted, up to the Day Before Booster
n=13695 Participants
The healthcare professionals who were vaccinated with this product early after the marketing approval of this product (participants in the Investigation of Health Status of Recipients Vaccinated First conducted by the Science Research Group of the Ministry of Health, Labour and Welfare) as indicated in the approved local product document were observed for a period of 11 months from the day following 28 days after the final vaccination of the initial immunization with this product to 12 months after the final vaccination of the initial immunization with this product.
If booster vaccination was not conducted, the long-term safety after the initial immunization of this product during the follow-up period was assessed.
If booster vaccination was conducted, the long-term safety after the initial immunization of this product up to the day before booster vaccination was confirmed, and information on serious adverse events and COVID-19 were continuously obtained after booster vaccination.
This study only collected serious adverse events.
|
|---|---|
|
Number of Participants With Serious Adverse Events After Booster Vaccination
|
48 Participants
|
PRIMARY outcome
Timeframe: From the day of booster vaccination up to 11 months from the day following 28 days after the final vaccination of COMIRNATY. (out of scope of the safety evaluation)Population: Participants who received booster vaccination regardless of COMIRNATY or other COVID-19 vaccines
By using the information on COVID-19 entered in the CRF submitted by the physician, participants who were considered to be in a severe condition were identified and the number and proportion of the participants were tabulated with reference to the severity classification in the Guidance for Treatment of Novel Coronavirus Infection (COVID-19). Participants with severe COVID-19 were defined as any of the following actions taken during the period from disease onset to the outcome date: admission to an ICU; use of mechanical ventilation; or use of ECMO.
Outcome measures
| Measure |
COMIRNATY (Tozinameran) ; If the Booster Vaccination Was Conducted, up to the Day Before Booster
n=13695 Participants
The healthcare professionals who were vaccinated with this product early after the marketing approval of this product (participants in the Investigation of Health Status of Recipients Vaccinated First conducted by the Science Research Group of the Ministry of Health, Labour and Welfare) as indicated in the approved local product document were observed for a period of 11 months from the day following 28 days after the final vaccination of the initial immunization with this product to 12 months after the final vaccination of the initial immunization with this product.
If booster vaccination was not conducted, the long-term safety after the initial immunization of this product during the follow-up period was assessed.
If booster vaccination was conducted, the long-term safety after the initial immunization of this product up to the day before booster vaccination was confirmed, and information on serious adverse events and COVID-19 were continuously obtained after booster vaccination.
This study only collected serious adverse events.
|
|---|---|
|
Number of Participants With Severe COVID-19 After Booster Vaccination
|
0 Participants
|
PRIMARY outcome
Timeframe: From the day of booster vaccination up to 11 months from the day following 28 days after the final vaccination of COMIRNATY. (out of scope of the safety evaluation)Population: Participants who received booster vaccination regardless of COMIRNATY or other COVID-19 vaccines
A serious adverse reaction was any untoward medical occurrence attributed to the vaccines received as a booster vaccination resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; or congenital anomaly. Relatedness to COMIRNATY was assessed by the physician.
Outcome measures
| Measure |
COMIRNATY (Tozinameran) ; If the Booster Vaccination Was Conducted, up to the Day Before Booster
n=13695 Participants
The healthcare professionals who were vaccinated with this product early after the marketing approval of this product (participants in the Investigation of Health Status of Recipients Vaccinated First conducted by the Science Research Group of the Ministry of Health, Labour and Welfare) as indicated in the approved local product document were observed for a period of 11 months from the day following 28 days after the final vaccination of the initial immunization with this product to 12 months after the final vaccination of the initial immunization with this product.
If booster vaccination was not conducted, the long-term safety after the initial immunization of this product during the follow-up period was assessed.
If booster vaccination was conducted, the long-term safety after the initial immunization of this product up to the day before booster vaccination was confirmed, and information on serious adverse events and COVID-19 were continuously obtained after booster vaccination.
This study only collected serious adverse events.
|
|---|---|
|
Number of Participants With Serious Adverse Reactions After Booster Vaccination
|
2 Participants
|
Adverse Events
COMIRNATY (Tozinameran) (1) If the Booster Vaccination Was Conducted, up to the Day Before Booster.
Serious events: 120 serious events
Other events: 0 other events
Deaths: 1 deaths
COMIRNATY (Tozinameran) (2) If the Booster Vaccination Was Conducted, After the Booster.
Serious events: 48 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
COMIRNATY (Tozinameran) (1) If the Booster Vaccination Was Conducted, up to the Day Before Booster.
n=14537 participants at risk
The healthcare professionals who were vaccinated with this product early after the marketing approval of this product (participants in the Investigation of Health Status of Recipients Vaccinated First conducted by the Science Research Group of the Ministry of Health, Labour and Welfare) as indicated in the approved local product document were observed for a period of 11 months from the day following 28 days after the final vaccination of the initial immunization with this product to 12 months after the final vaccination of the initial immunization with this product.
If booster vaccination was not conducted, the long-term safety after the initial immunization of this product during the follow-up period was assessed.
If booster vaccination was conducted, the long-term safety after the initial immunization of this product up to the day before booster vaccination was confirmed, and information on serious adverse events and COVID-19 were continuously obtained after booster vaccination.
This study only collected serious adverse events.
|
COMIRNATY (Tozinameran) (2) If the Booster Vaccination Was Conducted, After the Booster.
n=13695 participants at risk
Same as the left.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia neonatal
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.01%
1/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Cardiac disorders
Atrial fibrillation
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Cardiac disorders
Prinzmetal angina
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Congenital, familial and genetic disorders
Cleft lip
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Congenital, familial and genetic disorders
Congenital skin disorder
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Congenital, familial and genetic disorders
Gnathoschisis
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Congenital, familial and genetic disorders
Patent ductus arteriosus
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.01%
2/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Eye disorders
Cataract
|
0.01%
2/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.01%
2/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.01%
1/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.01%
1/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Hepatobiliary disorders
Cholangitis
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.02%
3/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.01%
1/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Infections and infestations
Appendicitis
|
0.02%
3/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.01%
1/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Infections and infestations
Bacterial infection
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Infections and infestations
Bacterial prostatitis
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Infections and infestations
Cellulitis
|
0.01%
2/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Infections and infestations
COVID-19
|
0.06%
9/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.11%
15/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Infections and infestations
Cystitis
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Infections and infestations
Gastroenteritis
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Infections and infestations
Peritonsillar abscess
|
0.02%
3/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Infections and infestations
Peritonsillitis
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Infections and infestations
Pharyngitis
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Infections and infestations
Pneumonia bacterial
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Infections and infestations
Pyelonephritis
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.01%
1/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Infections and infestations
Pyelonephritis acute
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Infections and infestations
Tonsillitis
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.01%
1/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Infections and infestations
Viral infection
|
0.01%
2/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Injury, poisoning and procedural complications
Airway burns
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Injury, poisoning and procedural complications
Fractured coccyx
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.01%
2/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.01%
2/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.01%
2/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.03%
4/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.01%
2/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.02%
3/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioblastoma
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoproliferative disorder
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteric cancer
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Nervous system disorders
Cerebral artery embolism
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Nervous system disorders
Cerebral infarction
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.01%
1/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Nervous system disorders
Lacunar infarction
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.01%
2/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Nervous system disorders
Seizure
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.03%
5/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.04%
5/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion threatened
|
0.01%
2/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.01%
1/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Pregnancy, puerperium and perinatal conditions
Cervical incompetence
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.01%
2/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Pregnancy, puerperium and perinatal conditions
Foetal death
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Pregnancy, puerperium and perinatal conditions
Hyperemesis gravidarum
|
0.01%
2/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Pregnancy, puerperium and perinatal conditions
Placenta praevia
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Pregnancy, puerperium and perinatal conditions
Premature baby
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Pregnancy, puerperium and perinatal conditions
Premature labour
|
0.02%
3/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.01%
1/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Psychiatric disorders
Dissociative disorder
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Renal and urinary disorders
Calculus urinary
|
0.01%
2/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.01%
1/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Renal and urinary disorders
IgA nephropathy
|
0.01%
2/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.01%
1/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Renal and urinary disorders
Pelvi-ureteric obstruction
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.01%
2/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.01%
2/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.02%
3/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.01%
1/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Reproductive system and breast disorders
Ovarian hyperstimulation syndrome
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Respiratory, thoracic and mediastinal disorders
Catamenial pneumothorax
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.01%
1/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory distress syndrome
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.01%
1/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.00%
0/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder neonatal
|
0.00%
0/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.01%
1/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Gastrointestinal disorders
Acute abdomen
|
0.00%
0/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.01%
1/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.01%
1/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.01%
1/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.01%
1/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.01%
1/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Congenital, familial and genetic disorders
Osteochondrodysplasia
|
0.00%
0/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.01%
1/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Reproductive system and breast disorders
Ovarian cyst torsion
|
0.00%
0/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.01%
1/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Infections and infestations
Meningitis aseptic
|
0.00%
0/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.01%
1/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.01%
1/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.01%
1/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.00%
0/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.01%
1/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Nervous system disorders
Migraine
|
0.00%
0/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.01%
1/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.01%
1/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/14537 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
0.01%
1/13695 • From the day following 28 days after the final vaccination of COMIRNATY, If those who did not conducted the booster vaccination, the observation period was11 months, If booster vaccination was conducted, the obseravtion period was two types below. (1) Up to the day before booster vaccination. (2) After the booster vaccination. [From the day of booster vaccination up to the last day of observation period] (out of scope of the safety evaluation)
Only serious adverse events were collected in this study. Other (not Including serious) adverse events were not assessed.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER