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.
This is a spontaneous report downloaded from a contactable physician. This physician reported 2 reports for different patients. This is the 1st of 2 reports. An 80-year-old female patient received the 1st dose of vaccine via an unspecified route of administration, in Jan2021, at single dose, for COVID-19 immunisation. Medical history included neuropsychiatric symptoms and COVID-19 in 2020 (COVID-19 PCR virus: positive on 22Oct2020). Concomitant medications were not reported. The patient experienced consciousness decreased on 08Jan2021 with outcome of not recovered, febricula on 09Jan2021 with outcome of recovered on 09Jan2021, convulsion on 08Jan2021 with outcome of recovered on 08Jan2021. The patient was hospitalized due to the events (Jan2021) and was currently hospitalized. Case summary and reporter comment: reasons for vaccination of the patient: Over 65 years old, neuropsychiatric disorders. Has she passed COVID-19?: Yes, PCR positive 22Oct2020, she did not require emergency care or hospitalization. 1 dose administered. Additional information on ADRs: Hospitalization required due to persistence of low level of consciousness. Currently hospitalized (this record will be reviewed and modified when the episode is resolved). The seizure episode was witnessed by medical personnel. Another patient from the same residence also had seizures after vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained. Reporter's Comments: Reasons for vaccination of the patient: Over 65 years old, neuropsychiatric disorders. Has she passed COVID-19?: Yes, PCR positive 22Oct2020, she did not require emergency care or hospitalization. 1 dose administered. Additional information on ADRs: Hospitalization required due to persistence of low level of consciousness. Currently hospitalized The seizure episode was witnessed by medical personnel. Another patient from the same residence also had seizures after vaccination. Sender's Comments: Linked Report(s) : ES-PFIZER INC-2021069677 Same reporter/event/drug, different patient.
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