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.
positive COVID-19 virus test; COVID-19; Back pain; This is a spontaneous report received from a contactable healthcare professional by Pfizer from the products Regulatory Agency. The regulatory authority report number is GB-MHRA-ADR 24648457. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 17Dec2020 at a single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient experienced COVID-19 on 13Jan2021, which was reported as fatal. The patient also experienced positive COVID-19 virus test on 13Jan2021 and back pain on 08Jan2021. The clinical course was reported as follows: The patient was admitted with back pain and multiple co-morbidities and COVID-19 virus test was negative on admission on 08Jan2021. On 13Jan2021, the COVID-19 virus test was positive (reported as 3 weeks and 6 days after his first vaccination on 17Dec2020). The clinical outcome of positive COVID-19 virus test and COVID-19 was fatal and of back pain was unknown. The patient died on 20Jan2021. The cause of death was reported as positive COVID-19 virus test and COVID-19. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about batch number cannot be obtained.; Reported Cause(s) of Death: COVID-19
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