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.
Fatigue; followed by blurred vision; violent vomiting; My son complained of nausea; He then fainted and fell from a sitting position onto the floor. He fainted for about 15 to 30 seconds; He then fainted and fell from a sitting position onto the floor. He fainted for about 15 to 30 seconds; Vaccination site reaction; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the regulatory authority-WEB. The reporter is the parent. Regulatory number: DE-PEI-CADR2021136559. Other Case identifier(s): DE-CADRPEI-2021136559 (web portal), DE-PEI-202100133200. A 12 year-old male patient received bnt162b2 (COMIRNATY), administration date 10Jul2021 (Lot number: FC1440) at the age of 12 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYNCOPE (medically significant), FALL (medically significant) all with onset 11Jul2021, outcome "recovering" and all described as "He then fainted and fell from a sitting position onto the floor. He fainted for about 15 to 30 seconds"; VACCINATION SITE REACTION (non-serious) with onset 10Jul2021, outcome "recovering", described as "Vaccination site reaction"; FATIGUE (non-serious) with onset 11Jul2021, outcome "recovering", described as "Fatigue"; VISION BLURRED (non-serious) with onset 11Jul2021, outcome "recovering", described as "followed by blurred vision"; VOMITING (non-serious) with onset 11Jul2021, outcome "recovering", described as "violent vomiting"; NAUSEA (non-serious) with onset 11Jul2021, outcome "recovering", described as "My son complained of nausea". Sender's comments: No Known allergies. No Information on risk factors or previous illnesses.The regulatory authority assessed the causal relationship between bnt162b2 (COMIRNATY) and Vision blurred and Syncope as D. Unclassifiable. The regulatory authority assessed the causal relationship between bnt162b2 (COMIRNATY) and Nausea as B. Indeterminate. No follow-up attempts are possible. No further information is expected.
|COVID19 (COVID19 (PFIZER-BIONTECH))||Unknown||COVID19||PFIZER\BIONTECH||FC1440||Unknown||Unknown|