VAERS ID: 2147324

AGE: | SEX: M|STATE: CT

Description

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

Symptoms

Autopsy, Body mass index, Gene sequencing, Investigation, Microscopy, Myocarditis, SARS-CoV-2 test, Toxicologic test

Vaccines

VAX DATE: | ONSET DATE: | DAYS TO ONSET:
NameDose #TypeManufacturerLotRouteSite
COVID19 (COVID19 (PFIZER-BIONTECH)) 2 COVID19 PFIZER\BIONTECH Unknown Unknown

RECVDATE:02-27-2022
RPT_DATE:
CAGE_YR:
CAGE_MO:
DIED:Y
DATEDIED:
L_THREAT:U
ER_VISIT:U
HOSPITAL:U
HOSPDAYS:
X_STAY:U
DISABLE:U
RECOVD:N
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
V_ADMINBY:
OTHER_MEDS:
CUR_ILL:
HISTORY:Medical History/Concurrent Conditions: Obesity
PRIOR_VAX:
SPLTTYPE:USPFIZER INC202200277013
FORM_VERS:2
TODAYS_DATE:02-22-2022
BIRTH_DEFECT:U
OFC_VISIT:U
ER_ED_VISIT:U
ALLERGIES:
V_FUNDBY:

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