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.
Pericardial effusion; left Pleural effusion; diarrhoea; chest pain; Pleurisy; palpitations; inappetence; dyspnoea; Perimyocarditis; pyrexia; Viral infection; This is a spontaneous report from a contactable physician received from the Regulatory Agency (RA). Regulatory authority report number is v21129245. The patient was a 15-year-old female. On 02Sep2021, the patient received the first dose of BNT162B2 (COMIRNATY solution of injection, Lot number FD0349, Expiration date 31Oct2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 24Sep2021 (the day of vaccination), the patient received the second dose of bnt162b2 (COMIRNATY solution of injection, Lot number FJ7489, Expiration date 31Jan2022) via an unspecified route of administration as a single dose for COVID-19 immunization. On 26Sep2021 (2 days after the vaccination), the patient experienced pleurisy and perimyocarditis. On 28Sep2021 (4 days after the vaccination), the patient was admitted to the hospital. The course of the event was as follows: The patient was healthy ever since born. On 24Sep2021, the patient received above vaccine. From 25Sep2021, the patient experienced pyrexia. On 26Sep2021, the patient experienced pyrexia of 38.5 centigrade degrees, palpitations, inappetence, and had a consultation in fever outpatient in the hospital. There were seemingly side effects, and the patient was given pyretic for processing method. But the patient went back home and experienced dyspnoea. On 27Sep2021, the patient experienced diarrhoea and chest pain. On 28Sep2021, the patient had a consultation again. The patient experienced left pleural effusion and pericardial effusion. There was no change in electrocardiogram. The patient was hospitalized. The outcome of the event was not reported. The reporting physician classified the event as serious (hospitalized from 28Sep2021) and assessed that the causality between the event and BNT162B2 as unassessable. Other possible causes of the events such as any other diseases was viral infection in 2021. No follow-up attempts are possible. No further information is expected.
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| Name | Dose # | Type | Manufacturer | Lot | Route | Site |
|---|---|---|---|---|---|---|
| COVID19 (COVID19 (PFIZER-BIONTECH)) | 2 | COVID19 | PFIZER\BIONTECH | FJ7489 |
| RECVDATE: | 10-28-2021 | RPT_DATE: |
| CAGE_YR: | |
| CAGE_MO: | |
| DIED: | U |
| DATEDIED: | |
| L_THREAT: | U |
| ER_VISIT: | |
| HOSPITAL: | Y |
| HOSPDAYS: | |
| X_STAY: | U |
| DISABLE: | U |
| RECOVD: | U |
| LAB_DATA: | Test Date: 20210926; Test Name: body temperature; Result Unstructured Data: Test Result:38.5 Centigrade; Test Date: 20210928; Test Name: electrocardiogram; Result Unstructured Data: Test Result:no change |
| V_ADMINBY: | OTH |
| OTHER_MEDS: | |
| CUR_ILL: | |
| HISTORY: | |
| PRIOR_VAX: | |
| SPLTTYPE: | JPPFIZER INC202101362814 |
| FORM_VERS: | |
| TODAYS_DATE: | 10-27-2021 |
| BIRTH_DEFECT: | U |
| OFC_VISIT: | Y |
| ER_ED_VISIT: | U |
| ALLERGIES: | |
| V_FUNDBY: |
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