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.
positive antigen test; positive antigen test; This is a spontaneous report received from a non-contactable Physician. The reporter is the patient. A 27-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 11Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 27 years for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. Patient did not have other medication in 2weeks. It was reported that day 6 after completion of Paxlovid (day 11 after positive antigen test) developed rhinorrhea, and antigen test was again positive (after negative on day 7). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive; (unspecified date) Negative; (06Jun2022) again Positive. Patient received Paxlovid from 27May2022 to 31May2022 for Treatment of COVID-19. Outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the reported events drug ineffective and Covid 19 cannot be completely excluded.
|COVID19 (COVID19 (PFIZER-BIONTECH))||3||COVID19||PFIZER\BIONTECH||Unknown||Unknown|
|LAB_DATA:||Test Name: antigen test; Test Result: Negative ; Test Date: 202205; Test Name: antigen test; Test Result: Positive ; Test Date: 20220606; Test Name: antigen test; Result Unstructured Data: Test Result:again Positive|
|HISTORY:||Medical History/Concurrent Conditions: Asthma|