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.
Patient presented to Emergency Department (ED) lethargic and listless. He proceeded to a shock state and had a cardiac arrest. He was not able to be resuscitated and died in the ED.
|COVID19 (COVID19 (PFIZER-BIONTECH))||1||COVID19||PFIZER\BIONTECH||FK5618||IM||RA|
|LAB_DATA:||Notable Labs between 12:55 am and Glucose 180 mg/dl Electrolyte CO2 13 mmol/L Troponin I 26.97 ng/ml (0-0.4 nl range) PT 14.2 (nl 9.5-12.1 sec); INR 1.4 (0.9-1.1) BNP 2096 pg/nL ( 0-99 nl) Lactate 20 mmol/L (0-2.0 nl) Initial ECG Rate 151; right axis deviation; non-specific intra-ventricular conduction block; T wave inversion in inferior leads Later ECG Rate 86; Low voltage QRS, ST depression in inferior and anterolateral leads; non-specific T wave abnormality; borderline prolonged QT|
|CUR_ILL:||None noted. Emergency Department (ED) visit note stated that patient had a fever in the last 24 hours, had no respiratory symptoms but became lethargic. Vomited on way to the ED and was listless and lethargic on presentation. No history of rashes, ingestion or trauma.|
|HISTORY:||None. Primary care visit in 2021 showed BMI 62|