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.
Previously healthy 16 year old young man presenting with chest pain admitted for myopericarditis. He was in his usual state of good health until 2 days ago when he experienced fever, chills and myalgias after receiving his 2nd dose of COVID pfizer vaccine. He improved until 5/2 when he developed a crushing, non-radiating, substernal chest pain which was waxing and waning in nature without specific alleviating factors. He had shortness of breath, but no palpitation, dizziness, or changes in pain on exertion vs rest. Family activated EMS who gave 325 mg of aspirin en route to the ED. In the ED, he was afebrile and hemodynamically stable. He was mildly diaphoretic, but otherwise, unremarkable on physical exam. STAT EKG showed ST elevations in V5 and V6 and ST depressions in V1 and V2 as well as PR depressions, which persisted on repeated EKG. Given concern for myopericarditis, they ordered labs including CBC, CMP, troponin and inflammatory markers which were only remarkable for troponin of 1.94 and CRP 3.5. Chest x-ray was normal. Cardiology was consulted and they recommended transthoracic echo which is pending. Cards also recommended starting Ibuprofen 600 mg q8 hrs and admission to cards for further management.
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||IM||AR|
|LAB_DATA:||EKG, ECHO, Cardiac MRI, CXR, Labs (CBC, CMP, Trop, Inflam markers,|
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