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.
Vigilance decreased; Concentration impaired; Amnesia; Syncope; Weight bearing difficulty; This is a spontaneous report received from a non-contactable reporter(s) (Physician) from the Regulatory Authority-WEB. Other Case identifier(s): DE-PEI-202200098638 (RA), DE-DCGMA-22197491 (RA). A 16-year-old female patient received BNT162b2 (COMIRNATY), on 25Feb2022 as dose 2, single (Lot number: 1F1042A) at the age of 16 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: comirnaty (DOSE NO 01, Strength (number) :0.3, Strength (unit) :mL (MILLILITRE)), administration date: 26Jan2022, for Prophylactic vaccination. The following information was reported: AMNESIA (hospitalization) with onset 26Feb2022, outcome "not recovered"; DISTURBANCE IN ATTENTION (hospitalization) with onset 26Feb2022, outcome "not recovered", described as "Concentration impaired"; SYNCOPE (hospitalization) with onset 26Feb2022, outcome "not recovered"; DISTURBANCE IN ATTENTION (hospitalization) with onset 26Feb2022, outcome "unknown", described as "Vigilance decreased"; WEIGHT BEARING DIFFICULTY (hospitalization) with onset 26Feb2022, outcome "not recovered". The patient underwent the following laboratory tests and procedures: Alcohol test: UNKNOWN; Blood glucose abnormal: UNKNOWN; Blood test: UNKNOWN; Blood thyroid stimulating hormone: UNKNOWN; Drug screen: unknown. Therapeutic measures were taken as a result of disturbance in attention, disturbance in attention, amnesia, syncope, weight bearing difficulty. Clinical course: Relatedness of drug to reactions for the events Vigilance decreased, Concentration impaired, Amnesia, Syncope, Weight bearing difficulty are Source of assessment :RA ; Result of Assessment :D. Unclassifiable. No follow-up attempts are possible. No further information is expected.; Reporter's Comments: Measures: symptoms Accompaniment, current neuropediatric diagnosis
|COVID19 (COVID19 (PFIZER-BIONTECH))||2||COVID19||PFIZER\BIONTECH||1F1042A||Unknown||Unknown|
|LAB_DATA:||Test Name: alcohol test; Result Unstructured Data: Test Result:UNKNOWN; Test Name: blood sugar; Result Unstructured Data: Test Result:UNKNOWN; Test Name: Blood work; Result Unstructured Data: Test Result:UNKNOWN; Test Name: Thyroid Stimulating Hormone; Result Unstructured Data: Test Result:UNKNOWN; Test Name: drug screening; Result Unstructured Data: Test Result:unknown|