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.
COVID infection; COVID infection; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). An 11-year-old male patient received BNT162b2 (BNT162B2), on 06Nov2021 as dose 1, single (Batch/Lot number: unknown) and in Nov2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for COVID-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. It was unknown whether the patient received any other vaccine within 4 weeks prior to the vaccine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "recovered" and all described as "COVID infection". The patient underwent the following laboratory tests and procedures: COVID-19 PCR test (nasal swab) in May2021, which was positive. It was unknown if therapeutic measures were taken as a result of drug ineffective and COVID-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
|COVID19 (COVID19 (PFIZER-BIONTECH))||2||COVID19||PFIZER\BIONTECH||OT||Unknown|
|LAB_DATA:||Test Date: 202205; Test Name: COVID-19 PCR Nasal Swab; Test Result: Positive|
|HISTORY:||Medical History/Concurrent Conditions: Asthma|