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.
Respiratory condition was aggravated; Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the Pharmaceuticals and Medical Devices Agency (PMDA). Regulatory authority report number is v21125306. A 72-years-old male patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date not reported), via an unspecified route of administration on 24Jul2021 as dose 2, single for covid-19 immunisation. Body temperature before vaccination and family history were not reported. The patient medical history and concomitant medications were not reported. The patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date not reported), via an unspecified route of administration on 03Jul2021 as dose 1, single for covid-19 immunisation. On 26Aug2021 (1 month 2 days after the vaccination), the respiratory condition was aggravated at 22:00, and emergency service was requested. The emergency squad arrived at the site, after which cardio-respiratory arrest occurred. The patient was transported to the reporting hospital and died on 26Aug2021. It was reported whether autopsy was done or not. The outcome of the events was fatal. The reporting physician classified the events as serious (death) and assessed the causality between the events and BNT162b2 as unassessable. It was not reported whether there were other possible causes of the events such as any other diseases. The lot number for BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: Respiratory condition was aggravated; Cardio-respiratory arrest
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