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.
Haemorrhage; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. A 51-year-old female patient received BNT162b2 (COMIRNATY), on 26Oct2021 as dose 2, single (Lot number: SDEH4) for covid-19 immunisation. The patient's relevant medical history included: "Hay fever" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: comirnaty (Dose 1, single, Batch/lot number -SCVC6 , Date of start of reaction-15Oct2021), administration date: 13Sep2021, for COVID-19 Immunization, reaction(s): "Infection"; comirnaty (Dose 1, single, Batch/lot number -SCVC6 , Date of start of reaction-15Oct2021), administration date: 13Sep2021, for COVID-19 immunization, reaction(s): "Vaginal Infection", "Paresthesia", "Inflammation", "Emmeniopathy", "Fatigue", "Meanopause", "Immunodeficiency", "Heavy menstrual bleeding", "Surgery". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 26Oct2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered"; HAEMORRHAGE (hospitalization, medically significant) with onset 15Dec2021, outcome "not recovered". The causality assessment for suspect drug to event Haemorrhage is Source of assessment -RA,Result of Assessment -D. Unclassifiable Sender Comment: Do you or the person concerned have any known allergies? If so, what are they? Hay fever Details of risk factors or pre-existing conditions: None / Immunodeficiency, constant infections, weak, tired, loss of tolerance to exertion; the heavy bleeding confines me to bed; I have to change pads every half an hour during the day and every hour at night, even though I'm only lying down; the bleeding never stops. I am no longer able to stand up. Second vaccination with Comirnaty on 26Oct2021, batch: SDEH4. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : DE-PFIZER INC-202200843700 For same patient,different dose and events;
|COVID19 (COVID19 (PFIZER-BIONTECH))||2||COVID19||PFIZER\BIONTECH||SDEH4||Unknown||Unknown|
|HISTORY:||Medical History/Concurrent Conditions: Hay fever|