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.
He was in his usual state of good health. 5 days after receiving the vaccine, he complained of brief unilateral shoulder pain (unclear to family which shoulder), which the family attributed to a musculoskeletal source. No chest pains, shortness of breath, or palpitations. He was playing with 2 friends at a community pond, swinging from a rope swing, flipping in the air, and landing in the water feet first. He surfaced, laughed, told his friends "Wow, that hurt!", then swam toward shore, underwater as was his usual routine. The friends became worried when he did not re-emerge. His body was retrieved by local authorities more than an hour later.
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|COVID19 (COVID19 (PFIZER-BIONTECH))||2||COVID19||PFIZER\BIONTECH||Unknown||Unknown|
|LAB_DATA:||Autopsy report 6/21/2021. Pertinent findings include: no external indication of scalp injury, with small subgaleal hemorrhage over the left occiput; normal epidural, subdural, and subarachnoid evaluations; mildly elevated cardiac mass 420 mg; normal pericardial appearance; normal coronary artery origins from the aorta and free of atherosclerosis; increased left ventricular wall thickness (1.8 cm) and normal right ventricular wall thickness (0.3 cm); normal gross appearance of the endocardium, myocardium, and cardiac valves; small foci of myocardial inflammation of the lateral wall of the left ventricle with myocyte necrosis; negative myocyte disarray; negative toxicology; negative SARS-CoV-2 RT-PCR; Ambry Genetics CardioNext analysis of 92 genes associated with inherited cardiomyopathies and arrhythmias negative for pathologic findings, positive for 2 variants of unknown significance.|
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