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.
All died within the 5 weeks after there first shot; This is a spontaneous report from a contactable consumer. This consumer reported similar events for six patients. This is the sixth of six reports. An elderly patient of unknown gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date of 2021, as single dose for covid-19 immunization. The patient' s medical history and concomitant medications were not reported. Patient was residential home with 5 other elderly residents patient. Reporter stated that they all got vaccinated with the first Pfizer shot (Confirmed as Covid 19 vaccine) and they all died within the 5 weeks after their first shot. By 18Mar2021 these residents in the house would have died. The reporter stated that they should not have died they just died. The reporter doesn' t know if it was a side effect, he knows if it was a reaction but all of the six residents that got vaccinated died within their first vaccination shot. Within the 5 weeks after the first vaccination. Reporter stated they died in their sleep supposedly. They died in their sleep. Outcome of the event was fatal. It was unknown if an autopsy was done. The information on the batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021617030 same reporter/SD/AE, different patients; Reported Cause(s) of Death: died within the 5 weeks after there first shot
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(If this is a foreign report without a description you will be able to read the description in the Wayback Machine on Medalerts if the report became public for the first time before November 18, 2022.)
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