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.
partner with COVID sx since 02May2022 and then tested positive on 07May; partner with COVID sx since 02May2022 and then tested positive on 07May; feels seriously ill; hard to breathe; fever; HA; This is a spontaneous report received from a non-contactable reporter(s) (Nurse). A 28-year-old male patient received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL3247), on 17Feb2021 as dose 2, single (Lot number: EL3247) and on 01Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 27 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 09May2022, outcome "unknown", described as "HA"; MALAISE (non-serious) with onset 09May2022, outcome "unknown", described as "feels seriously ill"; PYREXIA (non-serious) with onset 09May2022, outcome "unknown", described as "fever"; DYSPNOEA (non-serious) with onset 09May2022, outcome "unknown", described as "hard to breathe"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09May2022, outcome "unknown" and all described as "partner with COVID sx since 02May2022 and then tested positive on 07May". The events "partner with covid sx since 02may2022 and then tested positive on 07may", "feels seriously ill", "hard to breathe", "fever" and "ha" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07May2022) Positive; (09May2022) Positive. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162b2.
|Vaccine Type||Manufacturer||Vaccine Name||Dose||Route||Site||Lot|
|RECVDATE:||12 May 2022|
|LAB_DATA:||Test Date: 20220507; Test Name: Home Ag; Test Result: Positive ; Test Date: 20220509; Test Name: Home Ag; Test Result: Positive|
|TODAYS_DATE:||11 May 2022|