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.
Myocarditis; This is a literature report. An adolescent male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, MANUFACTUERER UNKNOWN), for COVID-19 immunisation. The following information was reported: MYOCARDITIS (death), outcome "fatal", described as "Myocarditis". The patient underwent the following laboratory tests and procedures: autopsy: microscopic myocardial findings, notes: There was global myocardial injury similar to that seen above, but with more widespread transmural ischemic changes and more interstitial inflammation, again with a predominant neutrophil component with histiocytes and scant lymphocytes; body mass index: 30; gene sequencing: unknown results; investigation: several sections had transmural, confluent areas, notes: of contraction bands apart from any inflammation, and florid neutrophilic inflammation with some histiocytes. In this case, a subepicardial distribution of injury was not seen.There were no acute or organizing thrombi; 520 grams with biventricular dilatation and, notes: marked pulm onary edema (combined lung weight=1481 grams); microscopy: microscopic findings are not the alterations seen, notes: with typical myocarditis. This suggest a role for cytokine storm which may occur with an excessive inflammatory response, as there also is a feedback loop between catecholamines and cytokines; sars-cov-2 test: pcr tissue testing performed by the cdc on heart, notes: lung found no molecular evidence of SARS-CoV-2 infection; toxicologic test: negative for medications and drugs of abuse. Therapeutic measures were not taken as a result of myocarditis. The patient date of death was unknown. The reported cause of death was myocarditis. The autopsy revealed "biventricular dilatation" (dilatation ventricular); "pulmonary edema" (pulmonary oedema); "global myocardial injury" (myocardial injury).; Sender's Comments: Based on the currently available information the possibility of causal association between the event Myocarditis and the suspect drug BNT162B2 cannot be ruled out. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : PFIZER INC-202200276862 Same drug/event, different patient; Reported Cause(s) of Death: Myocarditis; Autopsy-determined Cause(s) of Death: biventricular dilatation; pulmonary edema; global myocardial injury
Open in Wayback Machine
(If this is a foreign report without a description you will be able to read the description in the Wayback Machine on Medalerts if the report became public for the first time before November 18, 2022.)
|COVID19 (COVID19 (PFIZER-BIONTECH))||2||COVID19||PFIZER\BIONTECH||Unknown||Unknown|
|LAB_DATA:||Test Name: autopsy results; Result Unstructured Data: Test Result:microscopic myocardial findings; Comments: There was global myocardial injury similar to that seen above, but with more widespread transmural ischemic changes and more interstitial inflammation, again with a predominant neutrophil component with histiocytes and scant lymphocytes; Test Name: BMI; Result Unstructured Data: Test Result:30; Test Name: Cardiac molecular testing; Result Unstructured Data: Test Result:unknown results; Test Name: Cardiac sections; Result Unstructured Data: Test Result:Several sections had transmural, confluent areas; Comments: of contraction bands apart from any inflammation, and florid neutrophilic inflammation with some histiocytes. In this case, a subepicardial distribution of injury was not seen.There were no acute or organizing thrombi.; Test Name: Heart Gross; Result Unstructured Data: Test Result:520 grams with biventricular dilatation and; Comments: marked pulm onary edema (combined lung weight=1481 grams).; Test Name: microscopic; Result Unstructured Data: Test Result:microscopic findings are not the alterations seen; Comments: with typical myocarditis. This suggest a role for cytokine storm which may occur with an excessive inflammatory response, as there also is a feedback loop between catecholamines and cytokines.; Test Name: SARS-COV-2 nasal swab testing; Result Unstructured Data: Test Result:PCR tissue testing performed by the CDC on heart; Comments: lung found no molecular evidence of SARS-CoV-2 infection.; Test Name: Expanded forensic toxicological testing; Result Unstructured Data: Test Result:negative for medications and drugs of abuse|
|HISTORY:||Medical History/Concurrent Conditions: Obesity|