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.
Intestinal perforation; This is a spontaneous report from a contactable physician. This is a report received from the products Regulatory Agency. Regulatory authority report number is GB-MHRA-WEBCOVID-202101272220168460 and Safety Report Unique Identifier of GB-MHRA-ADR 24657435. An 87-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 14Jan2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19, and was not enrolled in a clinical trial. The patient experienced intestinal perforation on 15Jan2021, which was serious as it was life threatening, and lead to death. Details were as follows: patient was taken to emergency (A&E) by ambulance in afternoon of 15Jan2021, after being found at home poorly responsive, confused and hypotensive. The patient had been seen in the evening previously, by her son. Covid vaccine was reported as likely not relevant. In A&E, noted hypothermic, hypotensive, elevated D dimer, elevated -reactive protein (CRP) 199, AKI, WCC 5.8, diffusely tender abdomen. CXR L basal consolidation. Air under diaphragm bilaterally seen clinically not reported. CT TAP free fluid and free intraperitoneal air indicating perforated viscus. Likely sigmoid colon perforation and signs of diverticulitis. Patient had not tested positive for COVID-19 since the vaccination. COVID-19 virus test, was negative on 15Jan2021. The patient died on 16Jan2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Sender's Comments: The 87-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), on 14Jan2021, and didnot have symptoms associated with COVID-19. On 15Jan2021, she experienced intestinal perforation, with clinical and lab findings supporting sigmoid colon perforation and signs of diverticulitis. The fatal event was more likely an intercurrent disease, and unlikely causally related to BNT162B2.; 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.