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.
Found dead; Myocarditis; Headache; Fever; Appetite lost; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Agency (A)-WEB, regulatory authority number DE-PEI-202100217297. A 12-year-old Male patient received the second dose of Bnt162b2 (COMIRNATY) on 13Oct2021 at the age of 12-year-old (Lot/Batch: SDCN1) as 0.3 ml single dose for covid-19 immunisation. The patient's medical history included Distal arthrogryposis, Cardiomyopathy. Concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (COMIRNATY) on 22Sep2021 at the age of 12-year-old as 0.3 ml single dose for covid-19 vaccination/immunisation. On 14Oct2021 the patient experienced Fever, Headache, Appetite lost. On 15Oct2021 the patient experienced Found dead, Myocarditis. This report is serious due to death, life threatening. Relatedness of drug to reaction(s)/event(s): Source of assessment: Agency. Result of Assessment: D. Unclassifiable. Autopsy Done and Results was Available as Cardiac death in cardiomyopathy. The outcome of the event was fatal. No follow-up attempts are possible, no further inforamtion is expected.; Autopsy-determined Cause(s) of Death: Cardiac death in cardiomyopathy
|Vaccine Type||Manufacturer||Vaccine Name||Dose||Route||Site||Lot|
|RECVDATE:||11 November 2021|
|DATEDIED:||14 October 2021|
|HISTORY:||Medical History/Concurrent Conditions: Cardiomyopathy (Detected at autopsy); Distal arthrogryposis|
|TODAYS_DATE:||11 November 2021|