Source: VAERS.HHS.GOV
VAERS accepts reports of adverse events and reactions that occur following vaccination. Healthcare providers, vaccine manufacturers, and the public can submit reports to the system. While very important in monitoring vaccine safety, VAERS reports alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness. The reports may contain information that is incomplete, inaccurate, coincidental, or unverifiable. In large part, reports to VAERS are voluntary, which means they are subject to biases. This creates specific limitations on how the data can be used scientifically. Data from VAERS reports should always be interpreted with these limitations in mind.
The strengths of VAERS are that it is national in scope and can quickly provide an early warning of a safety problem with a vaccine. As part of CDC and FDA’s multi-system approach to post-licensure vaccine safety monitoring, VAERS is designed to rapidly detect unusual or unexpected patterns of adverse events, also known as “safety signals.” If a safety signal is found in VAERS, further studies can be done in safety systems such as the CDC’s Vaccine Safety Datalink (VSD) or the Clinical Immunization Safety Assessment (CISA) project. These systems do not have the same scientific limitations as VAERS, and can better assess health risks and possible connections between adverse events and a vaccine.
Key considerations and limitations of VAERS data:
VAERS data available to the public include only the initial report data to VAERS. Updated data which contains data from medical records and corrections reported during follow up are used by the government for analysis. However, for numerous reasons including data consistency, these amended data are not available to the public.
Acute pericarditis; extensive ST elevation; supraventricular and ventricular extrasystoles; supraventricular and ventricular extrasystoles; chest pain; This is a spontaneous report from a contactable pharmacist received from the regulatory authority. Regulatory authority report number is v21130328. This 14-year and 7-month-old male patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FJ7489, Expiration date 31Jan2022), via an unspecified route of administration, on 23Sep2021 at 10:00 (at the age of 14-year and 7-month-old) at single dose for COVID-19 immunisation. Body temperature before vaccination was not provided. Historical vaccine includes the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FG0978, Expiration Date: 30Nov2021), via an unknown route, on 02Sep2021 at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. The patient had no family history. On 10Oct2021 at 16:00 (17 days after the vaccination), the patient experienced acute pericarditis for which he was admitted at the hospital on the same day. The course of the event was as follows: the patient was awakened with chest pain at 04:00 AM (as reported) on 10Oct2021 and came to the hospital. There was no elevation of CK-MB or troponin I, etc., but electrocardiogram showed extensive ST elevation. Acute pericarditis was diagnosed, and the patient was admitted to the hospital. The patient had supraventricular and ventricular extrasystoles and oral acetylsalicylic acid (ASPIRIN) was administered as anti-inflammatory treatment. The symptoms and ECG improved over time, and the patient was discharged home on 19Oct2021, after it was confirmed that there was no exacerbation of arrhythmia even with an increase in activity level. The patient was recovering from the events. The reporting pharmacist classified the event 'acute pericarditis' as serious (Hospitalized from 10Oct2021 to 19Oct2021) and assessed that the event was related to BNT162B2. There was no other possible cause of the event such as any other diseases.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 2 | COVID19 | PFIZER\BIONTECH | FJ7489 |
| RECVDATE: | 11-11-2021 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | 9 |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | N |
| LAB_DATA: | Test Date: 20211010; Test Name: CK-MB; Result Unstructured Data: Test Result:no elevation; Test Date: 20211010; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:extensive ST elevation; Comments: extensive ST elevation; Test Date: 20211010; Test Name: troponin I; Result Unstructured Data: Test Result:no elevation |
| V_ADMINBY: | OTH |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | |
| PRIOR_VAX: | |
| SPLTTYPE: | JPPFIZER INC202101462842 |
| FORM_VERS: | |
| TODAYS_DATE: | 11-10-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | Y |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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