Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Viral infection
Clinical narrative: LYMPHOCYTIC MYOCARDITIS; TERMINAL/FATAL CARDIAC ARRHYTHMIA; DIARRHEA; FLU-LIKE SYMPTOMS; This spontaneous report received from a consumer concerned a 69 year male. The patient's weight was 270 pounds, and height was 69 inches. The patient's concurrent conditions included: high blood pressure/hypertension, insomnia, diverticulitis, hypertensive cardiovascular, cardiomegaly, left ventricular hypertrophy, biventricular dilatation, slight arteriolar nephrosclerosis, diabetes mellitus, social alcohol user, non smoker, moderate obesity, chronic venous stasis with brown discoloration of distal legs, liver slight steatosis, abdominal aorta with slight to moderate atherosclerosis, abdominal aorta with slight dilatation, ankles with minimal swelling, and pitting edema, and other pre-existing medical conditions included: The patient did not have any known allergies. The patient did not have history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: 21-SEP-2021) dose was not reported, 1 total, administered on 06-APR-2021 for prophylactic vaccination. Concomitant medications included atorvastatin calcium and Irbesartan for high blood pressure.  On 06-APR-2021, the patient felt very lousy having flu-like symptoms and also experienced body aches, headache and felt like sick as a dog and those symptoms resolved with 2 to 3 days on 09-APR-2021. Further patient felt tired and was short of breath at times until 14-JUL-2021 that the patient had diarrhea and was the same thing the next day and was very tired. On an unspecified date, the patient experienced lymphocytic myocarditis with terminal/fatal cardiac arrhythmia. The patient passed away at home on 16-JUL-2021. On 21-JUL-2021, at 14:30 the autopsy was performed in private clinic by a HCP and the Covid-19 test (NR: not provided) was negative. Physician determined the cause of death was due to viral myocarditis (he mentioned that there were no elements of bacterial myocarditis and that was because of the vaccine).Physician stated that the patient died of heart infection, lymphocytic myocarditis, mostly due to a viral infection. Laboratory data (21-JUL-2021) included: Autopsy (NR: not provided) Lymphocytic myocarditis with terminal/fatal cardiac arrhythmia, Body mass index (NR: not provided) Moderate obesity (Body Mass Index of 39.9), and Microscopy (NR: not provided) Myocardium (nine microscopic sections) showing lymphocytic myocarditis. An autopsy was performed on family request. During autopsy report the patient did not have any external or internal injury and various system examination was performed like body cavities, head, neck, respiratory system, liver, gallbladder, pancreas, endocrine system, musculoskeletal system, hemic and lymphatic system were unremarkable. During autopsy in circulatory system the patient had enlarged heart weighted 528 grams and had a normal distribution of right predominant coronary arteries. The proximal segments of the left anterior descending and right coronary arteries had 30 to 40 percent occlusion. The remaining coronary arteries were relatively unremarkable. Toxicology were not requested, while autopsy histopathology was performed in heart (x9, A, B, C, D, E) myocardium with moderate to marked hypertrophy, most consistent with hypertension; multiple foci of lymphocytic infiltration (in all nine sections), diagnostic for lymphocytic myocarditis; without evidence of hemorrhagic infarction, contraction bands or myocardial disorganization and in lung (x5, A, B, C, D, E): pulmonary congestion and edema, no evidence of pneumonia, abscess, pulmonary emboli, asthma, or tumor. In liver (x2, A, B) slight steatosis, no evidence of hepatitis, cirrhosis, trauma, or tumor. In kidney (x2, D, E), slight arteriolar nephrosclerosis (due to hypertension). In spleen (x1, C): reactive hyperplasia; no evidence of malignancy. In autopsy urine chemistry was performed and the urine specimen was screened by a diabetic dipping test, which showed no terminal hyperglycemia or ketosis. No autopsy evidence of significant coronary artery disease, hemorrhagic brain, infarction, hemorrhagic heart infarction, pulmonary emboli, or fatal trauma.  Cause of death as per autopsy report was lymphocytic myocarditis with terminal/fatal cardiac arrhythmia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of lymphocytic myocarditis, terminal/fatal cardiac arrhythmia, and patient recovered from flu-like symptoms on 09-APR-2021, and the outcome of diarrhea was not reported. This report was serious (Death).; Sender's Comments: V0: 20210915593-COVID-19 VACCINE AD26.COV2.S-Lymphocytic myocarditis, Terminal/fatal cardiac arrhythmia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: LYMPHOCYTIC MYOCARDITIS; TERMINAL/FATAL CARDIAC ARRHYTHMIA; Autopsy-determined Cause(s) of Death: LYMPHOCYTIC MYOCARDITIS