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.
About 25 minutes after receiving vaccine complained of dizziness and being hot and nauseated. No difficulty breathing. No chest pain. B/P was 130/90 and was monitored. It went down to 124/80 after he started feeling better. He was wearing sweater over shirt and it was warm in building. Took sweater off. Cool wet cloth applied to back of neck. States he had only had a donut and cup of hot chocolate before receiving vaccine. Sprite and peanut butter crackers given. Became nauseated after eating peanut butter crackers Blood pressure monitored monitored. He laid on exam table for about 15 minutes. He felt better. Stood up and walked to conference room for another 15 minutes. Stated he felt much better and was ready to leave. Coworker drove him back. Received email from him letting us know he had made it back and they had stopped and eaten pizza on the way. Received text from coworker that he was dizzy and seeing spots and that his blood pressure had been 120/80 and then spiked to 160/100. Coworkers taking him to ER at Hospital for evaluation.
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(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.)
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