Source: VAERS.HHS.GOV
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 Non-Interventional Study report from a non-contactable consumer. A 49-year-old female patient received vaccine intramuscular on 05Jan2021 at single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. 15 minutes after vaccination the patient developed visual disturbances, dizziness and headache, and from a sudden strong pulse and rise in blood pressure, the events lasting for unknown. The patient was hospitalized from an unknown date in Jan2021. Outcome of events blood pressure and pulse rose was unknown, of other events was not recovered at the date of reporting. Reporter's comment: "15 minutes after vaccination I got dizzy, I saw blurred and blood pressure and pulse rose rapidly, others 20 minutes later RTW, 3 hours Surveillance in hospital, the next day to the family doctor and to the ophthalmologist, who asked and found that the visual performance has deteriorated, opticians prescribed new glasses, currently the patient still had strong headache and occasionally dizziness". No follow-up attempts are possible. No further information is expected.; Reporter's Comments: 15 minutes after vaccination I got dizzy, I saw blurred and blood pressure and pulse rose rapidly, others 20 minutes later, 3 hours Surveillance in hospital, the next day to the family doctor and to the ophthalmologist, who asked and found that the visual performance has deteriorated, opticians prescribed new glasses, currently the patient still had strong headache and occasionally dizziness.
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OpenVAERS is a private organization that posts publicly available CDC/FDA data of injuries reported post-vaccination. Reports are not proof of causality.