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.
STROKE/decreased consciousness and right-side paresis; This is a spontaneous report from a contactable physician downloaded from the Agency (EMA) Agency-WEB SE-MPA-2021-000972, other case identifier: SE-MPA-1611224017780, received from Regulatory Authority. A 72-year-old female patient received bnt162b2 (COMIRNATY, Batch/lot number: EL1484), via an unspecified route of administration on Jan2021 at unknown age at single dose for covid-19 immunisation. Medical history included progression of Alzheimer's disease and hypertension. The female was living in a special care home and got infected with Covid during Christmas weekend 2020 and a few days later on 30Dec2020 she tested positive for Covid. The female had sparse infection symptoms, no fever, but felt more tired than usual after the covid infection. The patient's concomitant medications were not reported. The female experienced a stroke on Jan2021. The reporter stated that according to guidelines the female was vaccinated with Comirnaty in mid-Jan2021 and fell ill 5 days later, decreased consciousness and right-side paresis. The reporter stated it was similar to a clinical picture in the event of a stroke, unknown if it was an ischemic stroke or caused by a bleeding. The female calmly died shortly thereafter. The patient underwent lab tests and procedures which included COVID19 test: positive on 30Dec2020. The patient died on Jan2021. Outcome of the event stroke was fatal. An autopsy was not performed. The reporter stated that the probability of death caused by Comirnaty is low. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: stroke
|COVID19 (COVID19 (PFIZER-BIONTECH))||Unknown||COVID19||PFIZER\BIONTECH||EL1484||Unknown||Unknown|
|LAB_DATA:||Test Date: 20201230; Test Name: COVID-19 virus test; Test Result: Positive|
|HISTORY:||Medical History/Concurrent Conditions: COVID-19 (during Christmas weekend 2020 and tested positive for Covid); Hypertension; Infection; Progression of Alzheimer's disease; Tiredness (more tired than usual after the covid infection)|