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.
Death/passed away; This is a spontaneous report from a contactable consumer or other non HCP (parent, father of patient). A 15-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 09Aug2021 at 09:00 AM (at the age of 15-year-old; lot number: FF2154) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The father reported that the patient (the son) received the dose 1 of the Pfizer vaccine on 09Aug2021 at 9AM on left arm. Unfortunately, patient passed away (death) on Friday 13Aug2021 at 04:30 without any history of illness. The event resulted in Emergency room/department or urgent care. Prior to vaccination, patient did not diagnose with COVID-19. Since the vaccination, patient did not test for COVID-19. Device date was 29Aug2021. No treatment received. Outcome of the event was fatal. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Death/passed away
|Vaccine Type||Manufacturer||Vaccine Name||Dose||Route||Site||Lot|
|RECVDATE:||02 September 2021|
|DATEDIED:||12 August 2021|
|TODAYS_DATE:||31 August 2021|