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.
Vomiting/food vomit; suspected heart attack; This is a spontaneous report from a contactable other healthcare professional downloaded from the Medicines Agency (MA) WEB ES-AEMPS-726097. An 80-years-old male patient received bnt162b2 (COMIRNATY), intramuscular on 04Jan2021 at 0.3 mL, single for covid-19 immunisation. Medical history included Mixed vascular and Lewy body dementia, with severe and rapidly progressive cognitive deterioration and with behavioral and psychological symptoms of dementia in treatment with trazodone, quetiapine, and lorazepam. Rivastigmine was not tolerated in July 2019. Cerebral vascular disease. Multiinfarction. Lacunar stroke Aug2019. Chronic obstructive pulmonary disease (COPD). Diabetes Mellitus II. Negative PCR 15Dec2020. Rapid Antigen Test screening 21Dec2020 negative. Concomitant medication included trazodone, quetiapine, lorazepam, all for dementia. Since the day of the vaccination, he has not presented new symptoms to his usual one. On the night of 12Jan2021, he developed food vomit and died 10 minutes later. They report suspected heart attack. It was unknown whether an autopsy has been performed. No follow-up attempts are possible, information on batch numbers cannot be obtained.; Reported Cause(s) of Death: Vomiting/food vomit; suspected heart attack
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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.