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.
experienced cognitive disruption for approximately 4 hours.; Disruption included inability to read; difficulty with speech/context/numbers.; This is a spontaneous report from a contactable consumer (patient). A 14-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0202 and Expiration Date: unknown), via an unknown route of administration, administered in left arm on 27Jun2021 at 13:00 (at the age of 14-years-old) as dose 2, single for covid-19 immunisation. The patient has no other medical history. The patient's concomitant medications were not reported. Patient has no known allergies. The patient previously took first dose of bnt162b2 (Lot number: EW0178) administered in left arm on 04Jun2021 at 12:00 PM (at the age of 14-years-old) as dose 1, single for covid-19 immunisation. Patient did not receive any other vaccine in four weeks. On 08Jul2021 at 10:00, 11 days after second dose, the patient experienced cognitive disruption for approximately 4 hours. Disruption included inability to read and difficulty with speech/context/numbers. The events resulted in emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with covid-19 and not tested for covid-19 post vaccination. No treatment was received for the events. Outcome of events was recovered on an unknown date in Jul2021.
|Vaccine Type||Manufacturer||Vaccine Name||Dose||Route||Site||Lot|
|RECVDATE:||29 July 2021|
|TODAYS_DATE:||28 July 2021|