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-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Jan2021 at 15:00 as dose 1, single (Lot number: EN9581), in left arm, on 02Mar2021 at 10:30 as dose 2, single (Lot number: EL3261), in left arm, on 30Sep2021 at 10:00 as dose 3 (booster), single (Lot number: 301485A), in left arm and on 13Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FJ4991) at the age of 68 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27May2022 at 06:00, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken with Paxlovid as a result of drug ineffective, covid-19. Patient not have any known allergy. Patient did not received any other medication in 2 weeks. Patient taking treatment with Paxlovid from 21May2022 to 25May2022. No follow-up attempts are possible. No further information is expected.
|COVID19 (COVID19 (PFIZER-BIONTECH))||4||COVID19||PFIZER\BIONTECH||FJ4991||Unknown||LA|
|LAB_DATA:||Test Name: Covid Test; Result Unstructured Data: Test Result:Unknown results|
|HISTORY:||Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: Other medical history: No|