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.
vomiting gastric juice; trembling; fainted and did not respond for a few seconds; fainted and did not respond for a few seconds; nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. A 17 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 22Oct2021 10:15 (Lot number: FE4728, Expiration Date: 31Jan2022) at the age of 17 years as DOSE 1, SINGLE for covid-19 immunisation. Relevant medical history included: "diagnosed with COVID-19" (unspecified if ongoing), notes: Prior to vaccination. The patient's concomitant medications were not reported. The following information was reported: SYNCOPE (medically significant), UNRESPONSIVE TO STIMULI (medically significant) all with onset 23Oct2021 10:15, outcome "not recovered" and all described as "fainted and did not respond for a few seconds"; NAUSEA (non-serious) with onset 23Oct2021 10:15, outcome "not recovered", described as "nausea"; VOMITING (non-serious) with onset 24Nov2021, outcome "not recovered", described as "vomiting gastric juice"; TREMOR (non-serious) with onset 24Nov2021, outcome "not recovered", described as "trembling". The events "fainted and did not respond for a few seconds", "fainted and did not respond for a few seconds", "nausea", "vomiting gastric juice" and "trembling" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of syncope, unresponsive to stimuli, nausea, vomiting, tremor. Clinical course: The patient's mother reported that her daughter fainted and was unresponsive twice, on 23Oct2021 and on 24Nov2021, and on both times it was accompanied by the reported events "nausea", second time including "vomiting" and "trembling". The patient was not Sars-Cov-2 tested post vaccination.
|Vaccine Type||Manufacturer||Vaccine Name||Dose||Route||Site||Lot|
|RECVDATE:||08 December 2021|
|HISTORY:||Medical History/Concurrent Conditions: COVID-19 (Prior to vaccination)|
|TODAYS_DATE:||06 December 2021|