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.
It felt as is it was instantly spreading. Within 30 seconds, I started get a sharp stabbing pain in my heart area; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Got both other vaccines as Pfizer also. Unlike my other two shots (the 1st was no symptoms)), for Covid-19 immunization, reaction(s): "the 1st was no symptoms"; Bnt162b2 (Dose=2, Got both other vaccines as Pfizer also. 2nd was flu-like symptoms for a day), for Covid-19 immunization, reaction(s): "2nd was flu-like symptoms for a day". The following information was reported: ANGINA PECTORIS (medically significant) with onset Oct2021, outcome "unknown", described as "It felt as is it was instantly spreading. Within 30 seconds, I started get a sharp stabbing pain in my heart area". Clinical course: The patient got both other vaccines as Pfizer also. Unlike other two shots (the 1st was no symptoms, and the 2nd was flu-like symptoms for a day), the shot instantly felt different being injected. It felt as it was instantly spreading. Within 30 seconds, patient started to get a sharp stabbing pain in the heart area. That lasted all day every few minutes. The patient was wanted to see if get any insight from the company about patients medical problems after getting the Pfizer booster back in Oct2021. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
|Vaccine Type||Manufacturer||Vaccine Name||Dose||Route||Site||Lot|
|RECVDATE:||12 May 2022|
|TODAYS_DATE:||11 May 2022|