COVID-19
Conditions
Keywords
Indonesia, Vaccine, BNT162b2
Brief summary
The purpose of this study is to characterize descriptively the BNT162b2 vaccination safety experience among the Indonesian people. We will look at adverse events (AEs) reported in Indonesia Vaccine Safety Website for people 12 years of age and older. AEs are unwanted reactions associated with the use of the BNT162b2 vaccine. They may or may not be caused by this vaccine. The secondary data collection will be exclusively from the Indonesia Vaccine Safety Website as requested by BPOM. This study does not seek additional participants. We will look at reported AEs for BNT162b2 vaccine since it became available in Indonesia. Individual data will be de-identified first before use. This will help protect personal information. We will study the AEs associated with the BNT162b2 vaccine in several ways. These include the type of AEs and which body parts affected, among others. This will help us understand it the vaccine is safe in Indonesian people.
Interventions
BIOLOGICALBNT162b2
BNT162b2 half dose and full dose
Sponsors
Pfizer
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
This study will include adverse events reported in Indonesia Vaccine Safety Website for individuals 12 years of age and older
Exclusion criteria
None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious Adverse Events (SAEs) After Primary Dose | The secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days) included AEs reported following administration of BNT162b2 mRNA SARS-CoV-2 vaccine from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years) | An SAE was any untoward medical occurrence at any dose that: suspected to cause death; required hospitalization; life-threatening; persistent or significant disability/incapacity. The number of participants with SAEs after administration of BNT162b2 mRNA SARS-CoV-2 vaccine primary dose are reported in this outcome measure. |
| Number of Participants With SAEs After Booster Dose | The secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days) included AEs reported following administration of BNT162b2 mRNA SARS-CoV-2 vaccine from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years) | An SAE was any untoward medical occurrence at any dose that: suspected to cause death; required hospitalization; life-threatening; persistent or significant disability/incapacity. The number of participants with SAEs after administration of BNT162b2 mRNA SARS-CoV-2 vaccine booster dose are reported in this outcome measure. |
| Number of Participants With Non Serious Adverse Events (Non SAEs) After Primary Dose | The secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days) included AEs reported following administration of BNT162b2 mRNA SARS-CoV-2 vaccine from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years) | An AE was any untoward medical occurrence in a participant; the event need not necessarily have a causal relationship with the treatment. AEs other than SAEs were considered non-SAEs. The number of participants with AEs after administration of BNT162b2 mRNA SARS-CoV-2 vaccine primary dose are reported in this outcome measure. |
| Number of Participants With Non SAEs After Booster Dose | The secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days) included AEs reported following administration of BNT162b2 mRNA SARS-CoV-2 vaccine from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years) | An AE was any untoward medical occurrence in a participant; the event need not necessarily have a causal relationship with the treatment. AEs other than SAEs were considered non-SAEs. The number of participants with AEs after administration of BNT162b2 mRNA SARS-CoV-2 vaccine booster dose are reported in this outcome measure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number and Type of Solicited AEs Reported | The secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days) included AEs reported following administration of BNT162b2 mRNA SARS-CoV-2 vaccine from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years) | An AE was any untoward medical occurrence in a participant who received BNT162b2 mRNA SARS-CoV-2 vaccine; the event need not necessarily have a causal relationship with the treatment. Solicited AEs are reported and are part of the uniform collection of information in the registry. These were classified as local reactions (local pain, local swelling, local erythema) and systemic reactions (fever, nausea/vomitus, headache, malaise/fatigue, arthralgia/myalgia, chill and diarrhea). |
| Number of SAEs Reported According to Time of Onset | Within 30min and>30min after vacc., secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days)included AEs reported following administration vacc. from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years) | An SAE was any untoward medical occurrence at any dose that: suspected to cause death; required hospitalization; life-threatening; persistent or significant disability/incapacity. The number of SAEs reported according to time of onset less than equal to (\<=30) minutes (min) and more than (\>) 30 minutes after administration of BNT162b2 mRNA vaccine primary and booster dose are reported in this outcome measure. |
| Number and Type of Unsolicited AEs Reported | The secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days) included AEs reported following administration of BNT162b2 mRNA SARS-CoV-2 vaccine from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years) | An AE was any untoward medical occurrence in a participant who received BNT162b2 mRNA SARS-CoV-2 vaccine; the event need not necessarily have a causal relationship with the treatment. Unsolicited AEs are volunteered or noted in an unsolicited manner and not as a required data element through a case report form. These were classified as local reactions (local sore, local itch and erythema) and systemic reactions (vertigo/dizziness, cough/rhinitis/sore throat, itchy, dyspnea/tachypnea, drowsiness, syncope/loss of consciousness, hypesthesia/paresthesia, chest pain/chest tightness, stomach ache/dyspepsia, seizure, paralysis/paresis, slurred speech, hyperhidrosis and insomnia). |
| Number of Participants According to Causality of SAEs | The secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days) included AEs reported following administration of BNT162b2 mRNA SARS-CoV-2 vaccine from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years) | An SAE was any untoward medical occurrence at any dose that: suspected to cause death; required hospitalization; life-threatening; persistent or significant disability/incapacity. The causality of SAEs were classified as coincidence: inconsistent causal association to immunization; vaccine reaction, indeterminate: when adequate information is available but it is not possible to assign it, unclassifiable. |
| Number of Participants According to Type of AEs | The secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days) included AEs reported following administration of BNT162b2 mRNA SARS-CoV-2 vaccine from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years) | AEs can be categorised into SAEs and non-SAEs. SAE was any untoward medical occurrence at any dose that: suspected to cause death; required hospitalization; life-threatening; persistent or significant disability/incapacity. An AE was any untoward medical occurrence in a participant; the event need not necessarily have a causal relationship with the treatment. AEs other than SAEs were considered non-SAEs. |
| Number of AEs Reported According to Solicited and Unsolicited AEs | The secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days) included AEs reported following administration of BNT162b2 mRNA SARS-CoV-2 vaccine from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years) | An AE was any untoward medical occurrence in a participant; the event need not necessarily have a causal relationship with the treatment. Solicited AEs are reported and are part of the uniform collection of information in the registry and unsolicited AEs are volunteered or noted in an unsolicited manner and not as a required data element through a case report form. |
Countries
Indonesia
Participant flow
Recruitment details
Data of participants who received BNT162b2 messenger ribonucleic acid (mRNA) Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-Cov-2) vaccine and reported adverse events (AE) in Indonesia were analysed in this study.
Pre-assignment details
This retrospective observational study used data from Indonesia Vaccine Safety Website as requested by Indonesia Food and Drug Monitoring Agency(BPOM). A total of 72,394,389 participants (48,425,165 \[primary dose\] and 23,969,029 \[booster dose\] received BNT162b2 mRNA SARS-CoV-2 vaccine. Adverse events were reported in 260 participants following administration of the BNT162b2 mRNA vaccine, starting from the time of vaccine availability in Indonesia and data was obtained for these 260 participants.
Participants by arm
| Arm | Count |
|---|---|
| BNT162b2 mRNA SARS-CoV-2 Vaccine Participants vaccinated with BNT162b2 mRNA SARS-CoV-2 vaccine and reported AEs were included in this retrospective observational study. | 260 |
| Total | 260 |
Baseline characteristics
| Characteristic | BNT162b2 mRNA SARS-CoV-2 Vaccine | — |
|---|---|---|
| Age, Customized 12-17 years | 37 Participants | — |
| Age, Customized 18-30 years | 78 Participants | — |
| Age, Customized 31-45 years | 83 Participants | — |
| Age, Customized 46-59 years | 37 Participants | — |
| Age, Customized Greater than (>) 59 years | 25 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 150 Participants | — |
| Sex: Female, Male Male | 110 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 150 | 2 / 110 |
| other Total, other adverse events | 134 / 150 | 105 / 110 |
| serious Total, serious adverse events | 16 / 150 | 5 / 110 |
Outcome results
Primary
Number of Participants With Non SAEs After Booster Dose
An AE was any untoward medical occurrence in a participant; the event need not necessarily have a causal relationship with the treatment. AEs other than SAEs were considered non-SAEs. The number of participants with AEs after administration of BNT162b2 mRNA SARS-CoV-2 vaccine booster dose are reported in this outcome measure.
Time frame: The secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days) included AEs reported following administration of BNT162b2 mRNA SARS-CoV-2 vaccine from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number of Participants With Non SAEs After Booster Dose | 105 Participants |
Primary
Number of Participants With Non Serious Adverse Events (Non SAEs) After Primary Dose
An AE was any untoward medical occurrence in a participant; the event need not necessarily have a causal relationship with the treatment. AEs other than SAEs were considered non-SAEs. The number of participants with AEs after administration of BNT162b2 mRNA SARS-CoV-2 vaccine primary dose are reported in this outcome measure.
Time frame: The secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days) included AEs reported following administration of BNT162b2 mRNA SARS-CoV-2 vaccine from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number of Participants With Non Serious Adverse Events (Non SAEs) After Primary Dose | 134 Participants |
Primary
Number of Participants With SAEs After Booster Dose
An SAE was any untoward medical occurrence at any dose that: suspected to cause death; required hospitalization; life-threatening; persistent or significant disability/incapacity. The number of participants with SAEs after administration of BNT162b2 mRNA SARS-CoV-2 vaccine booster dose are reported in this outcome measure.
Time frame: The secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days) included AEs reported following administration of BNT162b2 mRNA SARS-CoV-2 vaccine from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number of Participants With SAEs After Booster Dose | 5 Participants |
Primary
Number of Participants With Serious Adverse Events (SAEs) After Primary Dose
An SAE was any untoward medical occurrence at any dose that: suspected to cause death; required hospitalization; life-threatening; persistent or significant disability/incapacity. The number of participants with SAEs after administration of BNT162b2 mRNA SARS-CoV-2 vaccine primary dose are reported in this outcome measure.
Time frame: The secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days) included AEs reported following administration of BNT162b2 mRNA SARS-CoV-2 vaccine from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number of Participants With Serious Adverse Events (SAEs) After Primary Dose | 16 Participants |
Secondary
Number and Type of Solicited AEs Reported
An AE was any untoward medical occurrence in a participant who received BNT162b2 mRNA SARS-CoV-2 vaccine; the event need not necessarily have a causal relationship with the treatment. Solicited AEs are reported and are part of the uniform collection of information in the registry. These were classified as local reactions (local pain, local swelling, local erythema) and systemic reactions (fever, nausea/vomitus, headache, malaise/fatigue, arthralgia/myalgia, chill and diarrhea).
Time frame: The secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days) included AEs reported following administration of BNT162b2 mRNA SARS-CoV-2 vaccine from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number and Type of Solicited AEs Reported | Local pain | 48 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number and Type of Solicited AEs Reported | Local swelling | 24 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number and Type of Solicited AEs Reported | Local erythema | 7 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number and Type of Solicited AEs Reported | Fever | 113 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number and Type of Solicited AEs Reported | Nausea/vomiting | 51 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number and Type of Solicited AEs Reported | Headache | 43 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number and Type of Solicited AEs Reported | Malaise/fatigue | 34 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number and Type of Solicited AEs Reported | Arthralgia/myalgia | 17 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number and Type of Solicited AEs Reported | Chills | 11 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number and Type of Solicited AEs Reported | Diarrhea | 11 Events |
Secondary
Number and Type of Unsolicited AEs Reported
An AE was any untoward medical occurrence in a participant who received BNT162b2 mRNA SARS-CoV-2 vaccine; the event need not necessarily have a causal relationship with the treatment. Unsolicited AEs are volunteered or noted in an unsolicited manner and not as a required data element through a case report form. These were classified as local reactions (local sore, local itch and erythema) and systemic reactions (vertigo/dizziness, cough/rhinitis/sore throat, itchy, dyspnea/tachypnea, drowsiness, syncope/loss of consciousness, hypesthesia/paresthesia, chest pain/chest tightness, stomach ache/dyspepsia, seizure, paralysis/paresis, slurred speech, hyperhidrosis and insomnia).
Time frame: The secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days) included AEs reported following administration of BNT162b2 mRNA SARS-CoV-2 vaccine from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number and Type of Unsolicited AEs Reported | Local sore | 10 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number and Type of Unsolicited AEs Reported | Local itch | 5 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number and Type of Unsolicited AEs Reported | Erythema | 3 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number and Type of Unsolicited AEs Reported | Vertigo/dizziness | 44 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number and Type of Unsolicited AEs Reported | Itchy | 9 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number and Type of Unsolicited AEs Reported | Drowsiness | 9 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number and Type of Unsolicited AEs Reported | Syncope/loss of consciousness | 18 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number and Type of Unsolicited AEs Reported | Hypesthesia/paresthesia | 7 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number and Type of Unsolicited AEs Reported | Cough/rhinitis/sore throat | 9 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number and Type of Unsolicited AEs Reported | Chest pain/chest tightness | 8 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number and Type of Unsolicited AEs Reported | Stomach ache/dyspepsia | 6 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number and Type of Unsolicited AEs Reported | Dyspnea/tachypnea | 14 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number and Type of Unsolicited AEs Reported | Seizure | 3 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number and Type of Unsolicited AEs Reported | Paralysis/paresis | 3 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number and Type of Unsolicited AEs Reported | Slurred speech | 3 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number and Type of Unsolicited AEs Reported | Hyperhidrosis | 2 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number and Type of Unsolicited AEs Reported | Insomnia | 1 Events |
Secondary
Number of AEs Reported According to Solicited and Unsolicited AEs
An AE was any untoward medical occurrence in a participant; the event need not necessarily have a causal relationship with the treatment. Solicited AEs are reported and are part of the uniform collection of information in the registry and unsolicited AEs are volunteered or noted in an unsolicited manner and not as a required data element through a case report form.
Time frame: The secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days) included AEs reported following administration of BNT162b2 mRNA SARS-CoV-2 vaccine from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number of AEs Reported According to Solicited and Unsolicited AEs | Solicited | 359 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number of AEs Reported According to Solicited and Unsolicited AEs | Unsolicited | 154 Events |
Secondary
Number of Participants According to Causality of SAEs
An SAE was any untoward medical occurrence at any dose that: suspected to cause death; required hospitalization; life-threatening; persistent or significant disability/incapacity. The causality of SAEs were classified as coincidence: inconsistent causal association to immunization; vaccine reaction, indeterminate: when adequate information is available but it is not possible to assign it, unclassifiable.
Time frame: The secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days) included AEs reported following administration of BNT162b2 mRNA SARS-CoV-2 vaccine from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. Here Number of Participants Analyzed signifies the number of participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number of Participants According to Causality of SAEs | Coincidence | 12 Participants |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number of Participants According to Causality of SAEs | Vaccine Reaction | 0 Participants |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number of Participants According to Causality of SAEs | Unclassifiable | 2 Participants |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number of Participants According to Causality of SAEs | Indeterminate | 2 Participants |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Booster Dose | Number of Participants According to Causality of SAEs | Indeterminate | 1 Participants |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Booster Dose | Number of Participants According to Causality of SAEs | Coincidence | 3 Participants |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Booster Dose | Number of Participants According to Causality of SAEs | Unclassifiable | 0 Participants |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Booster Dose | Number of Participants According to Causality of SAEs | Vaccine Reaction | 1 Participants |
Secondary
Number of Participants According to Type of AEs
AEs can be categorised into SAEs and non-SAEs. SAE was any untoward medical occurrence at any dose that: suspected to cause death; required hospitalization; life-threatening; persistent or significant disability/incapacity. An AE was any untoward medical occurrence in a participant; the event need not necessarily have a causal relationship with the treatment. AEs other than SAEs were considered non-SAEs.
Time frame: The secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days) included AEs reported following administration of BNT162b2 mRNA SARS-CoV-2 vaccine from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number of Participants According to Type of AEs | SAEs | 21 Participants |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number of Participants According to Type of AEs | Non SAEs | 239 Participants |
Secondary
Number of SAEs Reported According to Time of Onset
An SAE was any untoward medical occurrence at any dose that: suspected to cause death; required hospitalization; life-threatening; persistent or significant disability/incapacity. The number of SAEs reported according to time of onset less than equal to (\<=30) minutes (min) and more than (\>) 30 minutes after administration of BNT162b2 mRNA vaccine primary and booster dose are reported in this outcome measure.
Time frame: Within 30min and>30min after vacc., secondary data analysis of structured AE data conducted from 15-Mar-2023 to 03-Apr-2023(approximately 20 days)included AEs reported following administration vacc. from 21-Aug-2021 to 14-Dec-2022(approximately 1.3 years)
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. Here Number of Participants Analyzed signifies the number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number of SAEs Reported According to Time of Onset | Onset Interval >30 Mins: Malaise/Fatigue | 5 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number of SAEs Reported According to Time of Onset | Onset Interval >30 Mins: Seizure | 2 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number of SAEs Reported According to Time of Onset | Onset Interval >30 Mins: Arthralgia/myalgia | 1 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number of SAEs Reported According to Time of Onset | Onset Interval >30 Mins: Paralysis/paresis | 2 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number of SAEs Reported According to Time of Onset | Onset Interval >30 Mins: Headache | 3 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number of SAEs Reported According to Time of Onset | Onset Interval >30 Mins: Slurred speech | 3 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number of SAEs Reported According to Time of Onset | Onset Interval >30 Mins: Chills | 2 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number of SAEs Reported According to Time of Onset | Onset Interval >30 Mins: Chest pain/chess tightness | 1 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number of SAEs Reported According to Time of Onset | Onset Interval >30 Mins: Local swelling | 0 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number of SAEs Reported According to Time of Onset | Onset Interval >30 Mins: Hyperhidrosis | 1 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number of SAEs Reported According to Time of Onset | Onset Interval >30 Mins: Fever | 7 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number of SAEs Reported According to Time of Onset | Onset Interval >30 Mins: Hypesthesia/paresthesia | 0 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number of SAEs Reported According to Time of Onset | Onset Interval >30 Mins: Syncope/loss of consciousness | 6 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number of SAEs Reported According to Time of Onset | Onset Interval >30 Mins: Insomnia | 1 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number of SAEs Reported According to Time of Onset | Onset Interval >30 Mins: Local pain | 2 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number of SAEs Reported According to Time of Onset | Onset Interval <=30 Mins: Fatigue | 0 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number of SAEs Reported According to Time of Onset | Onset Interval >30 Mins: Dyspnea/tachypnea | 3 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number of SAEs Reported According to Time of Onset | Onset Interval <=30 Mins: Syncope | 3 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number of SAEs Reported According to Time of Onset | Onset Interval >30 Mins: Nausea/vomiting | 5 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number of SAEs Reported According to Time of Onset | Onset Interval <=30 Mins: Dizziness | 0 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number of SAEs Reported According to Time of Onset | Onset Interval >30 Mins: Stomachache/dyspepsia | 3 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number of SAEs Reported According to Time of Onset | Onset Interval <=30 Mins: Chest pain | 1 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number of SAEs Reported According to Time of Onset | Onset Interval >30 Mins: Diarrhea | 3 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number of SAEs Reported According to Time of Onset | Onset Interval <=30 Mins: Hyperhidrosis | 0 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Number of SAEs Reported According to Time of Onset | Onset Interval >30 Mins: Vertigo/dizziness | 4 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Booster Dose | Number of SAEs Reported According to Time of Onset | Onset Interval <=30 Mins: Hyperhidrosis | 1 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Booster Dose | Number of SAEs Reported According to Time of Onset | Onset Interval >30 Mins: Fever | 3 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Booster Dose | Number of SAEs Reported According to Time of Onset | Onset Interval >30 Mins: Malaise/Fatigue | 2 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Booster Dose | Number of SAEs Reported According to Time of Onset | Onset Interval >30 Mins: Nausea/vomiting | 2 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Booster Dose | Number of SAEs Reported According to Time of Onset | Onset Interval >30 Mins: Headache | 2 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Booster Dose | Number of SAEs Reported According to Time of Onset | Onset Interval >30 Mins: Local pain | 1 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Booster Dose | Number of SAEs Reported According to Time of Onset | Onset Interval >30 Mins: Diarrhea | 0 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Booster Dose | Number of SAEs Reported According to Time of Onset | Onset Interval >30 Mins: Arthralgia/myalgia | 1 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Booster Dose | Number of SAEs Reported According to Time of Onset | Onset Interval >30 Mins: Local swelling | 1 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Booster Dose | Number of SAEs Reported According to Time of Onset | Onset Interval >30 Mins: Syncope/loss of consciousness | 1 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Booster Dose | Number of SAEs Reported According to Time of Onset | Onset Interval >30 Mins: Dyspnea/tachypnea | 2 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Booster Dose | Number of SAEs Reported According to Time of Onset | Onset Interval >30 Mins: Stomachache/dyspepsia | 1 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Booster Dose | Number of SAEs Reported According to Time of Onset | Onset Interval >30 Mins: Vertigo/dizziness | 0 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Booster Dose | Number of SAEs Reported According to Time of Onset | Onset Interval >30 Mins: Seizure | 1 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Booster Dose | Number of SAEs Reported According to Time of Onset | Onset Interval >30 Mins: Paralysis/paresis | 1 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Booster Dose | Number of SAEs Reported According to Time of Onset | Onset Interval >30 Mins: Slurred speech | 0 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Booster Dose | Number of SAEs Reported According to Time of Onset | Onset Interval >30 Mins: Chest pain/chess tightness | 0 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Booster Dose | Number of SAEs Reported According to Time of Onset | Onset Interval >30 Mins: Hyperhidrosis | 0 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Booster Dose | Number of SAEs Reported According to Time of Onset | Onset Interval >30 Mins: Hypesthesia/paresthesia | 1 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Booster Dose | Number of SAEs Reported According to Time of Onset | Onset Interval >30 Mins: Insomnia | 0 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Booster Dose | Number of SAEs Reported According to Time of Onset | Onset Interval <=30 Mins: Fatigue | 1 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Booster Dose | Number of SAEs Reported According to Time of Onset | Onset Interval <=30 Mins: Syncope | 0 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Booster Dose | Number of SAEs Reported According to Time of Onset | Onset Interval <=30 Mins: Dizziness | 1 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Booster Dose | Number of SAEs Reported According to Time of Onset | Onset Interval <=30 Mins: Chest pain | 0 Events |
| BNT162b2 mRNA SARS-CoV-2 Vaccine: Booster Dose | Number of SAEs Reported According to Time of Onset | Onset Interval >30 Mins: Chills | 0 Events |