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.
Heart attack; Had three strokes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "Heart attack"; CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "Had three strokes". Clinical Course:Patient already took second shot on 08Apr2021 and he mentioned about the heart problem something (Transferring agent was unsure, hence not captured as event). So, we are not sure if that happened before he took the vaccine or after taking the vaccine. He mentioned, he had a heart attack. He would also like information on how to get the booster shot because they are unable to get it from their doctor (Further clarification was unknown).Patient have had a heart attack and I have had three strokes and I cannot find any place to get shots and neither can my daughter and my daughter calls up on these different places because she 'has a hole in her heart' (Not appropriately clarified over the call, hence split case was not made. LOT# I find on here is and that was 1170828. I can't read this stuff on here it's so small I can't read it. The lot number for bnt162b2 was not provided and will be requested during follow up.
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