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.
volvulus; volvulus and needed surgery followed by further ischemia; This is a spontaneous report from a contactable physician. An 86-year-old female patient received her first single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) intramuscularly on 19Jan2021 for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient developed volvulus and needed surgery followed by further ischemia and at end of life. The events onset date reported as 27Jan2021. Patient had 3days hospitalization and died eventually. It was unknown if an autopsy was performed. Information about lot/batch number has been requested.; Sender's Comments: Very limited information was provided in this report. No relevant information regarding the clinical course of the events, the patient's underlying medical conditions were mentioned. Based on the information currently available, lacking any other alternative explanations as so far, the reported volvulus and Intestinal ischaemia are managed as related to COVID-19 vaccine, BNT162B2, for reporting purpose, only. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.; Reported Cause(s) of Death: volvulus; ischemia
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