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.
I?m received second dose Covid-19 Pfizer, I?m a direct lactating mother of and 11 months old male. I had onset of fever, chills and body aches starting a 230 pm day after vaccine. My baby started having fever 2 hours later. I direct fed him about one hour and a half after receiving the vaccine. He had fever Max of 101.7 and has continued to have after 72hours. He had change in the stool consistency and smell but not diarrhea. He had decrease intake today but otherwise asymptomatic. I?m a pediatrician. His physician exam is normal except for tiny lymph nodes palpable in his axila and inguinal rea. Today I checked his urine dip and was negative. No other testing has been completed. Fever has been control easily with Tylenol and the last 2 doses I have chosen to give Motrin. Baby is well appearing, active and playful otherwise. No history of contacts. We have no social contact with anybody for months, no grocery shopping, use N95 when seeing patients but I?m mostly Telehealth. My 5 yo is virtual student and does not have any symptoms. My husband has received first dose Covid and is also asymptomatic. I don?t have any reason to think there is any other etiology rather than my vaccine administration. My symptoms resolved after 30hours. I only had mild arm pain with first dose and baby was completely asymptomatic
Open in Wayback Machine
(If this is a foreign report without a description you will be able to read the description in the Wayback Machine on Medalerts if the report became public for the first time before November 18, 2022.)
|COVID19 (COVID19 (PFIZER-BIONTECH))||2||COVID19||PFIZER\BIONTECH||IM||LA|
Questions? Comments? Bugs?
Due to the high volume of inquiries, please be patient with response times.
AND PLEASE read the FAQ first.