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.
She is bleeding out of her vagina; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A 5 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 14Jan2022 10:30 (Lot number: FL0007) at the age of 5 years as dose 1 (tris), single for covid-19 immunisation. Relevant medical history included: "no" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: No, reaction(s): "Allergy". The following information was reported: VAGINAL HAEMORRHAGE (medically significant) with onset 24Jan2022 07:00, outcome "unknown", described as "She is bleeding out of her vagina". The event "she is bleeding out of her vagina" was evaluated at the physician office visit. Therapeutic measures were taken as a result of vaginal haemorrhage, vaginal disorder. Clinical course: The patient is now having vaginal issues. She is bleeding out of her vagina. She has never had this issue before the vaccine. For treatment they are currently working with doctors to treat. Additional information: the patient had no other vaccine in four weeks, no other medications in two weeks, no covid prior vaccination and no Known allergies.
|COVID19 (COVID19 (PFIZER-BIONTECH))||1||COVID19||PFIZER\BIONTECH||FL0007||Unknown||RA|
|HISTORY:||Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: no|