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.
oxygen saturation between 80-85%; Fever greater or equal to 38 grades Celsius; headache; myalgia; arthralgia; respiratory distress; pharyngeal pain; cough; dyspnea; This is a spontaneous report from a non-contactable other hcp via e-mail. A 31-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left arm at first single dose on 24Dec2020 for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications were not reported. Starting a clinical course on 01Jan2021, at the start of the watch at 08:00 hours, patient referred headache, myalgias and arthralgias, pharyngeal pain, cough, dyspnea respiratory distress, leaving home. Later, on 02Jan2021 in the morning, patient also referred to fever greater or equal to 38 grades Celsius, headache, myalgias and arthralgias, oxygen saturation between 80-85%; Hospitalization is decided, CT with CORADS 3. Later, on Sunday (03Jan2021), she presented with 95% saturation without oxygen, asymptomatic and afebrile, for which she was discharged home. Outcome of the event was recovered on 03Jan2021. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
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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.