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.
Client received first dose of Moderna Vaccine. Consent signed by the client's mother. Per manufacturer's guidelines, client was not eligible for the vaccine due to being under the age of 18. Dr. notified Moderna and the Center for Disease Control and Prevention (CDC) of the incident. Parents were notified that the first dose that was given to the child was not in accordance with the CDC and manufacturer's guidelines. They were also informed that the CDC and Moderna were notified of the incident and that the CDC has allowed the second dose series to be administered to children 16 years and older in similar situations. The parent/guardian was given the option to return to the clinic at the scheduled interval and for their child to receive the second dose series to provide better protection against the COVID-19 infection.
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