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| ID | Type | Description | Link |
|---|---|---|---|
| NCT05621239 | Registry Identifier | ClinicalTrials.gov |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COMIRNATY | COVID-19 mRNA vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BNT162b2 | Biological | BNT162b2 half dose and full dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
| 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. | 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) |
| 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. | 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) |
| Number of Participants With Non SAEs After Booster Dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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
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people in Indonesia above 12 years of age who received vaccine and report an adverse event
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer | Jakarta | Indonesia |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Analysis population included all eligible participants whose data were retrieved and observed in this study.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | Count of Participants | Participants | 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) |
|
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)
This was a retrospective, observational study for secondary data collection and analysis of structured data regarding AEs reported in Indonesia NC AEFI database, following administration of BNT162b2 mRNA vaccine.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BNT162b2 mRNA SARS-CoV-2 Vaccine: Primary Dose | Participants vaccinated with primary dose of BNT162b2 mRNA SARS-CoV-2 vaccine and reported AEs were included in this retrospective observational study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| General disorders | Non-systematic Assessment | AEs reported here are based on only sign and symptoms and were not investigated further (secondary data collection), hence diagnosis was unknown. |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquires@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 26, 2023 | Apr 2, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000090982 | BNT162 Vaccine |
| ID | Term |
|---|---|
| D000087503 | mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
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Observational study for secondary data collection and analysis of structured data
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.
| 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) |
| 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) |
| 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. | 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) |
| 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. | 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) |
| 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. | 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) |
| 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). | 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) |
| 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). | 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) |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | 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. | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | Count of Participants | Participants | 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) |
|
|
|
| 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. | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | Count of Participants | Participants | 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) |
|
|
|
| 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. | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | Count of Participants | Participants | 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) |
|
|
|
| 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. | 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. | Posted | Number | Events | 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) |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | 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) |
|
|
|
| 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. | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | Count of Participants | Participants | 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) |
|
|
|
| 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. | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | Number | Events | 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) |
|
|
|
| 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). | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | Number | Events | 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) |
|
|
|
| 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). | Analysis population included all eligible participants whose data were retrieved and observed in this study. | Posted | Number | Events | 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) |
|
|
|
| 3 |
| 150 |
| 16 |
| 150 |
| 134 |
| 150 |
| EG001 | BNT162b2 mRNA SARS-CoV-2 Vaccine: Booster Dose | Participants vaccinated with booster dose of BNT162b2 mRNA SARS-CoV-2 vaccine reporting AEs were included in this retrospective observational study. | 2 | 110 | 5 | 110 | 105 | 110 |
| Ischemic stroke | Nervous system disorders | Non-systematic Assessment |
|
| Hemorrhagic stroke | Nervous system disorders | Non-systematic Assessment |
|
| Guillain-Barre syndrome | Nervous system disorders | Non-systematic Assessment |
|
| Diabetic ketoacidosis | Endocrine disorders | Non-systematic Assessment |
|
| COVID-19 | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Abortus | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Hellp syndrome | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Caries dentist | Gastrointestinal disorders | Non-systematic Assessment |
|
| Anaphylactic shock | General disorders | Non-systematic Assessment |
|
|
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.
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| D000941 | Antigens |
| D001685 | Biological Factors |
| Onset Interval >30 Mins: Nausea/vomiting |
|
| Onset Interval >30 Mins: Headache |
|
| Onset Interval >30 Mins: Local pain |
|
| Onset Interval >30 Mins: Diarrhea |
|
| Onset Interval >30 Mins: Arthralgia/myalgia |
|
| Onset Interval >30 Mins: Chills |
|
| Onset Interval >30 Mins: Local swelling |
|
| Onset Interval >30 Mins: Syncope/loss of consciousness |
|
| Onset Interval >30 Mins: Dyspnea/tachypnea |
|
| Onset Interval >30 Mins: Stomachache/dyspepsia |
|
| Onset Interval >30 Mins: Vertigo/dizziness |
|
| Onset Interval >30 Mins: Seizure |
|
| Onset Interval >30 Mins: Paralysis/paresis |
|
| Onset Interval >30 Mins: Slurred speech |
|
| Onset Interval >30 Mins: Chest pain/chess tightness |
|
| Onset Interval >30 Mins: Hyperhidrosis |
|
| Onset Interval >30 Mins: Hypesthesia/paresthesia |
|
| Onset Interval >30 Mins: Insomnia |
|
| Onset Interval <=30 Mins: Fatigue |
|
| Onset Interval <=30 Mins: Syncope |
|
| Onset Interval <=30 Mins: Dizziness |
|
| Onset Interval <=30 Mins: Chest pain |
|
| Onset Interval <=30 Mins: Hyperhidrosis |
|
| Unclassifiable |
|
| Indeterminate |
|
| Title | Measurements |
|---|---|
|
| Fever |
|
| Nausea/vomiting |
|
| Headache |
|
| Malaise/fatigue |
|
| Arthralgia/myalgia |
|
| Chills |
|
| Diarrhea |
|
| Title | Measurements |
|---|---|
|
| Vertigo/dizziness |
|
| Cough/rhinitis/sore throat |
|
| Itchy |
|
| Drowsiness |
|
| Syncope/loss of consciousness |
|
| Hypesthesia/paresthesia |
|
| Chest pain/chest tightness |
|
| Stomach ache/dyspepsia |
|
| Dyspnea/tachypnea |
|
| Seizure |
|
| Paralysis/paresis |
|
| Slurred speech |
|
| Hyperhidrosis |
|
| Insomnia |
|