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.
COVID-19 pneumonia/sars-cov-2 infection/dyspnoea, cough and pyrexia; COVID-19 pneumonia; SARS-CoV-2 infection; pyrexia; cough; Dyspnoea; This is a spontaneous report received from a contactable physician by Pfizer from the products Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202101261732199850. Safety Report Unique Identifier GB-MHRA-ADR 24651485. A 92-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK1768), via an unspecified route of administration on 15Jan2021 at single dose for COVID-19 immunization. Medical history included cardiac pacemaker insertion, hypertension, chronic lymphocytic leukaemia, atrial fibrillation, type 2 diabetes mellitus, angina pectoris, prostate cancer, deep vein thrombosis, cardiac failure. Concomitant medication included allopurinol, atorvastatin, hydralazine, lansoprazol, isosorbide mononitrate (MONOMIL XL), rivaroxaban for atrial fibrillation. On 17Jan2021, patient was admitted with shortness of breath/ dyspnoea, cough and pyrexia, he was suspected covid-19 then confirmed having sars-cov-2 infection and covid-19 pneumonia. The patient underwent lab tests included COVID-19 virus test: positive on 17Jan2021. It was not sure if he was carrying the virus at the time of vaccination. He said he didn't have any temperature at the time of the vaccination. Outcome of event covid-19 pneumonia was fatal, sars-cov-2 infection was not recovered, and the events pyrexia, cough, dyspnoea was unknown. The patient died on 21Jan2021. It was not reported if an autopsy was performed. The cause of death was covid-19 pneumonia/drug ineffective. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: COVID-19 pneumonia; COVID-19 pneumonia
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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.