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.
FAINTING; HYPOTONIC HYPORESPONSIVE EPISODE; This spontaneous report received from a physician by a Regulatory Authority (RA, PL-URPL-3-14007-2021) on 22-JUN-2022 and concerned a 31 year old of unspecified sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C16-04 expiry: 31-MAR-2023) 0.5 ml, 01 total (dose 1), administered on 25-JUN-2021 at 12:38 for covid-19 immunisation. Age at time of vaccination 31 years old. No concomitant medications were reported. On 25-JUN-2021, at 12:50 the patient experienced fainting, and hypotonic hyporesponsive episode. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fainting and hypotonic hyporesponsive episode was not reported. This report was serious (Other Medically Important Condition).
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