Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Brain natriuretic peptide, C-reactive protein, Chest X-ray, Echocardiogram
Clinical narrative: Acute myocarditis; This case has been considered invalid as Other-Info not qualifying for AE reporting - Literature report: No patient.  This is a literature report for the following literature source-privacy.  Follow-up (20Jan2022): This is a literature report for the following literature source: This is a literature report for the following literature source(s): privacy.  A 40 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "coronavirus disease 2019 (COVID-19) pneumonia" (unspecified if ongoing), notes: four months earlier. The patient's concomitant medications were not reported. Past drug history included: Testosterone. The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "recovered", described as "Acute myocarditis". The patient underwent the following laboratory tests and procedures: aspartate aminotransferase: 66 IU/l; atrial pressure: 12 mmHg; biopsy: revealed myocyte hypertrophy, notes: with rare non-specific myocyte vacuolization, but no evidence of inflammatory cell infiltration; blood creatinine: 26.62 ng/ml, notes: peaked 10 hours later at 46.65 ng/mL; blood creatinine: 1.08 mg/dl; blood pressure measurement: 142/84 mmHg; body temperature: 36.9 Centigrade; brain natriuretic peptide: 104.6 pg/mL; chest x-ray: showed no evidence of acute cardiopulmonary proces; c-reactive protein: 7.6 mg/dl; echocardiogram: showed improvement in left ventricular ejection, notes: fraction to 70 percent. on day of discharge (4 days after admission); electrocardiogram: showed normal sinus rhythm, notes: with non-specific T- wave inversions and resolution of diffuse ST elevations; showed normal sinus rhythm, notes: with diffuse ST elevations across all leads, except lead III and aVR and V1 where there were ST depressions; full blood count: was notable for 15,600 white blood, notes: cells per microliter (74% neutrophils, 15.6% lymphocytes, 0.1% eosinophils); heart rate: 107 beats per minute; immunohistochemistry: demonstrated no significant findings; investigation: greater then 400, notes: positive threshold above 15; laboratory test: demonstrated no significant findings; magnetic resonance imaging: showed left ventricular ejection fraction 52percen, notes: and normal regional motion of the ventricles Myocardial edema and delayed enhance- ment in the inferior wall of the basal left ventricular myocardium were noted; microscopy: demonstrated no significant findings; oxygen saturation: 100 %, notes: on ambient air; pulmonary arterial wedge pressure: 23 mmHg; red blood cell sedimentation rate (normal high range 15): 19 mm/hour; transaminases: 32 IU/l; troponin i: 8,935 ng/L, notes: peaked 10 hours later at 20301.0 ng/L. Therapeutic measures were taken as a result of myocarditis.  Clinical outcome: Upgraded the case from invalid to valid.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a causal relation between the event  myocarditis and the administration of the vaccine cannot be excluded. 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.