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.
lymph node swelling in the jaw; Development of basalioma on the forehead; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: DE-PEI-CADR2022282402 (RA). Other Case identifier(s): DE-CADRPEI-2022282402 (RA Webportal), DE-PEI-202200086740 (RA). A 48-year-old female patient received BNT162b2 (COMIRNATY), on 15Jun2021 as dose 2, single (Lot number: FD9234) for covid-19 immunisation. The patient's relevant medical history included: "Bee venom" (unspecified if ongoing); "Dexamethasone" (unspecified if ongoing); "Prednisolone" (unspecified if ongoing); "Nuts" (unspecified if ongoing); "Guinea Pig" (unspecified if ongoing); "bronchopneumonia", start date: 2009 (unspecified if ongoing); "small pulmonary embolism", start date: 2013 (unspecified if ongoing); "Hashimoto's thyroiditis" (unspecified if ongoing); "neurodermatitis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1 Manufacturer Unknown), for COVID-19 immunisation. The following information was reported: BASAL CELL CARCINOMA (medically significant) with onset 26Jul2021, outcome "not recovered", described as "Development of basalioma on the forehead"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "lymph node swelling in the jaw". The patient underwent the following laboratory tests and procedures: tissue samples taken: Basalioma. Therapeutic measures were taken as a result of basal cell carcinoma, lymphadenopathy. The causality assessment for suspect drug to event 'Basalioma' was reported as follows: Source of assessment RA Result of Assessment D. Unclassifiable No follow-up attempts are possible. No further information is expected. No follow-up attempts are possible. No further information is expected.
|COVID19 (COVID19 (PFIZER-BIONTECH))||2||COVID19||PFIZER\BIONTECH||FD9234||Unknown||Unknown|
|LAB_DATA:||Test Name: tissue samples taken; Result Unstructured Data: Test Result:Basalioma|
|HISTORY:||Medical History/Concurrent Conditions: Allergy to animal; Allergy to nuts; Bee sting hypersensitivity; Bronchopneumonia; Drug allergy; Hashimoto's thyroiditis; Neurodermatitis; Pulmonary embolism|