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.
Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Authority-WEB. Regulatory number: AT-BASGAGES-2022-076718 (RA). A 57-year-old female patient received BNT162b2 (COMIRNATY), on 20Jun2021 as dose 1, single (Lot number: FD0168) and on 01Aug2021 as dose 2, single (Lot number: FF0680), all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 20Nov2021, outcome "unknown", described as "SARS-CoV-2 infection"; DRUG INEFFECTIVE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Vaccination failure". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Nov2021) Positive, notes: Variant PCR based: n.a. Variant sequenced: n.a. n501y-positive: Unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : AT-PFIZER INC-202200869394 same patient, product and different dose and event;
|COVID19 (COVID19 (PFIZER-BIONTECH))||2||COVID19||PFIZER\BIONTECH||FF0680||OT||Unknown|
|LAB_DATA:||Test Date: 20211120; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR based: n.a. Variant sequenced: n.a. n501y-positive: Unknown|