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.
General physical health deterioration; Cardiac failure; Lung edema; Cardiovascular disorder; This is a spontaneous report downloaded from the Medicines Agency (MA) WEB BE-FAMHP-DHH-N2021-75687. A contactable physician reported that a 85 years old female patient received first dose BNT162B2 (COMIRNATY), via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 vaccination. The medical history included hypertension, osteoporosis. Concomitant drugs were escitalopram (strength 10 mg), bumetanide (BURINEX, strength 1 mg), edoxaban tosilate (LIXIANA, strength 60 mg) and amlodipine besilate(AMLOR, strength 10 mg).On 20Jan2021 the patient suffered from cardiovascular disorder, lung edema, cardiac failure and general physical health deterioration during treatment with BNT162B2. The patient died on 20Jan2021. It's unknown if an autopsy was performed. The cause of death was cardiovascular disorder, lung edema, cardiac failure and general physical health deterioration. The outcome of events was fatal. Reporter Comment: no really obvious side effects after vaccination. earlier further deterioration (so this already deteriorated before vaccination) No follow-up attempts are possible. No further information is expected.; Reporter's Comments: no really obvious side effects after vaccination. earlier further deterioration (so this already deteriorated before vaccination); Reported Cause(s) of Death: General physical health deterioration; Cardiac failure; Lung edema; Cardiovascular disorder
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