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.
pulmonary edema; This is a spontaneous report from a Pfizer-sponsored program, from a contactable consumer (patent's uncle) through the Pfizer company doctor. A 14-year-old male patient received bnt162b2 (COMIRNATY), 1st dose on 06Jul2021 (Lot Number: EX0893) and 2nd dose on 27Jul2021 (Lot Number: EW2246, both via an unspecified route of administration as single dose for COVID-19 immunization. Medical history none. Concomitant medications were not reported. The patient experienced pulmonary edema (death) on 03Sep2021. The patient died on 03Sep2021. The autopsy revealed that the cause of death was pulmonary edema.; Reported Cause(s) of Death: pulmonary edema
|Vaccine Type||Manufacturer||Vaccine Name||Dose||Route||Site||Lot|
|RECVDATE:||09 September 2021|
|DATEDIED:||02 September 2021|
|HISTORY:||Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None|
|TODAYS_DATE:||09 September 2021|