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.
dead from second dose of Pfizer Covid 19 vaccine; This is a spontaneous report from a Pfizer-sponsored program by a non-contactable consumer. This report reported same event for two patients. This is the first dose of two reports. A 13-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE at the age of 13-year-old for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2) for covid-19 immunisation. A 13 years old female is dead from second dose of Pfizer Covid 19 vaccine. Both had no prior conditions with the heart and now are dead. The patient died on an unspecified date. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101091793 same report/drug/AE, different patients; Reported Cause(s) of Death: dead from second dose of Pfizer Covid 19 vaccine
|Vaccine Type||Manufacturer||Vaccine Name||Dose||Route||Site||Lot|
|RECVDATE:||29 August 2021|
|TODAYS_DATE:||26 August 2021|