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.
Stroke; bleed to brain; This is a spontaneous report from a contactable consumer. This is a report received from the HA. Regulatory authority report number GB-MHRA-WEBCOVID-202101282143521990, Safety Report Unique Identifier GB-MHRA-ADR 24663909. An 85-year-old female patient received BNT162B2, via an unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunisation. Medical history included 5 years previous had urinary tract infection which led to discitis, followed by severe osteoporosis and blood clot. Patient had not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not enrolled in clinical trial. Concomitant medication included amlodipine. The patient experienced stroke, and bleed to brain on 16Jan2021. Patient had vaccine on the 12Jan2021 and was prior to this very fit and well. Then patient died suddenly and unexpectedly with no prior illness in the proceeding days. Post mortum stated bleed to brain. Patient had not tested positive for COVID-19 since having the vaccine. Post mortum: No signs of anaphylaxis. Outcome of the events was fatal. The patient died on 16Jan2021. It was not reported if an autopsy was performed. No follow-up attempts possible; information regarding batch/lot cannot be obtained; No further information expected.; Reported Cause(s) of Death: stroke; bleed to brain
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