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VAERS data do not represent all known safety information for a vaccine and should be interpreted in the context of other scientific information.VAERS data is limited to vaccine adverse event reports received between 1990 and the most recent date for which data are available.The number of reports alone cannot be interpreted or used to reach conclusions about the existence, severity, frequency, or rates of problems associated with vaccines.Reports may include incomplete, inaccurate, coincidental and unverified information.Vaccine providers are encouraged to report any clinically significant health problem following vaccination to VAERS, whether or not they believe the vaccine was the cause.Key considerations and limitations of VAERS data: 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. Or unexpected patterns of adverse events, also known as “safety signals.” If a safety signal is found in VAERS, further studies can beĭone in safety systems such as the CDC’s Vaccine Safety Datalink (VSD) or the Clinical Immunization Safety Assessment (CISA) project. 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.Īs part of CDC and FDA’s multi-system approach to post-licensure vaccine safety monitoring, VAERS is designed to rapidly detect unusual This creates specific limitations on how the data can be used scientifically.ĭata from VAERS reports should always be interpreted with these limitations in mind. In large part, reports to VAERS are voluntary, That is incomplete, inaccurate, coincidental, or unverifiable. If a vaccine caused or contributed to an adverse event or illness. While very important in monitoring vaccine safety, VAERS reports alone cannot be used to determine
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Healthcare providers, vaccine manufacturers, and the public can submit reports to the system. VAERS accepts reports of adverse events and reactions that occur following vaccination.