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.
I had no reaction following the vaccination. The next day I had very mild soreness at the injection site. The next morning (about 36 hours after the vaccination) I woke up with fatigue and a sore throat. I had breakfast and about 10 minutes later I vomited everything (projectile vomiting, no nausea or abdominal pain). An hour later I had episode of severe watery diarrhea (just one episode). Felt very weak so I decided to sit down, stumbled to a chair, and then proceeded to have a syncopal episode with about 4 minutes of seizure like activity (witnessed, I don't remember that part). Decided to go to the ER, where I had labs, EKG, CXR, head CT scan, MRI and EEG. I was admitted for 24 hour observation, all the tests were normal.
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|COVID19 (COVID19 (PFIZER-BIONTECH))||1||COVID19||PFIZER\BIONTECH||EK 5730||IM||LA|
|LAB_DATA:||12/17/2020: Na+ 141, K+ 4.4, Cl 101, CO 24, BUN 13, Cr 0.82, Glucose 124, Ca 10.6, Mg 1.7 WBC 11.3, HB 18.1, Hct 52.2, Plts 173 Lactic acid 4.9 (range 0.5-2.2), repeat after hydration 1.1 CXR, CT scan of brain, MRI and E of brain, and EEG all normal|
|OTHER_MEDS:||Bystolic 5mg once a day Prilosec 20mg once a day One a Day multivitamins|
|CUR_ILL:||No other illnesses at the time of vaccination or one month prior.|
|HISTORY:||History of hypertension and GERD.|
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