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.
Cardiac failure aggravated; breathing difficulties; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is SE-MPA-2021-001654 and other case identifier number SE-MPA-1611657205772. An 89-year-old female patient received BNT162B2 (COMIRNATY; Lot number EL1484), intramuscular in Jan2021 as single dose for covid-19 immunization. Medical history included cardiac failure from an unknown date and unknown if ongoing and atrial fibrillation from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced cardiac failure aggravated in Jan2021, which was serious as it lead to death. The patient also experienced breathing difficulties in Jan2021, with unknown outcome. Details were as follows: patient had palliative care prescriptions since Apr2020, but was sent to hospital with breathing difficulties three days after the vaccination and died the same day. The patient was treated with CPAP (continuous positive airway pressure) and intravenous diuretic at the hospital. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cardiac failure aggravated
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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.