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.
17 y/o M with no PMHx presenting to ED from another ED for work-up of acute onset chest pain. Patient experienced this pain at approximately 2200 on 5/23 and this prompted ED visit. His chest pain was 8/10 at that time. Did not radiate. He mentioned pain with deep inspiration. Prior to Sunday night he describes feeling tired, malaise on Saturday. He says he had a fever on Saturday. Temperature at that time unknown. Otherwise patient was in usual state of health. Of note, Friday 5/21 was his second dose of the COVID-19 vaccine. He denies having any adverse effects after vaccine #1. Patient diagnosed with acute pericarditis at this time thought to be due to COVID-19 vaccine
Open in Wayback Machine
(If this is a foreign report without a description you will be able to read the description in the Wayback Machine on Medalerts if the report became public for the first time before November 18, 2022.)
|COVID19 (COVID19 (PFIZER-BIONTECH))||2||COVID19||PFIZER\BIONTECH||EW0185||IM||LA|
|COVID19 (COVID19 (PFIZER-BIONTECH))||1||COVID19||PFIZER\BIONTECH||EW0167||IM||LA|
|LAB_DATA:||5/23/21: His EKG there reflected ST elevations, troponin I of 10.7.|
|ALLERGIES:||No known drug allergies|
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