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.
SARS-CoV-2 infection; SARS-CoV-2 infection; This is a spontaneous report received from a contactable physician by Pfizer from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202101261748200590, Safety Report Unique Identifier GB-MHRA-ADR 24651574. A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiry date were not provided), via an unspecified route of administration on 24Dec2020 at single dose for COVID-19 immunization. Medical history included dementia from an unknown date and unknown if ongoing, chronic kidney disease from an unknown date and unknown if ongoing. Text for relevant medical history and concurrent conditions: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial. The patient's concomitant medications were not reported. The patient experienced SARS-COV-2 infection (death) on 28Dec2020. Reported that patient developed COVID on 28Dec2020, died on 03Jan2021. The patient underwent lab tests and procedures which included COVID-19 virus test: COVID/SARS-CoV-2 infection (Positive) on 28Dec2020, COVID-19 virus test: NO - Negative covid-19 test on an unknown date. The patient died on 03Jan2021. It was not reported if an autopsy was performed. The outcome of the events was fatal. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: SARS-CoV-2 infection
|Vaccine Type||Manufacturer||Vaccine Name||Dose||Route||Site||Lot|