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.
Dead; FEVER; Blood sugar decreased; This is a spontaneous report from a contactable nurse received from Regulatory Authority, downloaded from the Regulatory Authority-WEB (SE-MPA-2021-000794, other case identifier: SE-MPA-1611147230356). An 88-year-old female patient received BNT162B2 (COMIRNATY; Lot number EL1484) intramuscular in Jan2021 at 0.3 mL single for COVID-19 immunisation. Relevant medical history included diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medications included candesartan cilexetil (CANDEXETIL) from 08Sep2020, ferrous sulfate (DUROFERON) from 10Mar2020, pantoprazole sodium sesquihydrate (PANTOLOC) from 10Mar2020, linagliptin (TRAJENTA) from 01Dec2020, amlodipine from 08Sep2020, atorvastatin from 10Mar2020, bisoprolol from 21Nov2020, clopidogrel from 10Mar2020 and metformin from 21Nov2020. In Jan2021, the patient experienced fever, decreased blood sugar and died. According to the rapporteur, the female developed fever in the afternoon the same day as she got vaccinated with BNT162B2, during the night her blood sugar decreased. She was sent to hospital and died two days after vaccination with BNT162B2. The patient died in Jan2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: death
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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.