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.
Pt was given bexero followed by a pfizer covid-19 booster in the right arm while sitting on the exam table. Her body went flaccid and she became unresponsive to verbal stimuli instantly following the covid booster. I was able to catch the pt and safely guide her to a supine position on the table. Pt postured and began having tonic clonic activity in her eyes, arms, and legs. I called for Dr. assistance. Dr. responded to the room and began an examination. I got the pt's legs elevated for proper blood flow. After several seconds, pt was able to start rousing. Blood pressure and pulse both within normal limits at this time. Pt was given juice and water. Pt stayed supine with legs elevated for approximately 20 minutes. Pt then was instructed to lower her legs. Pt remained this way for several minutes. I then increased the incline in small increments, giving her several minutes to adjust after each increase. Once at 90 degrees pt was instructed to let legs dangle from the table. At this point pt reported feeling back to normal. Dr. examined pt once more and gave the ok to stand. Pt stood for several minutes and after reporting that she felt back to normal was deemed safe to leave clinic. Pt was monitored constantly by clinic staff, from the start of the episode until deemed safe to leave clinic by Dr. The concludes my report. Report given and by the time I arrived in the room patient was lying supine on table with knees bent with fluttering of eyelids noted but no tonic clonic activity or posturing. Within 5 seconds she opened her eyes and responded to her name and asked if she passed out. She then appropriately answered questions for the remainder of the time. I suspect she had a vasovagal episode with associated tonic-clonic activity due to brief anoxia given she did not have a post-ictal period and given she reported feeling lightheaded right before the event (but did not verbalize this at the time). Given the immediate nature of the syncope, will report to VAERS, but discussed with patient this appeared more consistent with vasovagal response and would be ok with her receiving future doses under close supervision.
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