Sex: F
Vaccine: COVID19
Symptoms: Adenovirus test, Alanine aminotransferase, Aspartate aminotransferase, Atrial pressure, Biopsy
Clinical narrative: Fulminantmyocarditis following coronavirus disease 2019 vaccination; This is a literature report.  A 80 year-old female patient received bnt162b2 (BNT162B2), administration date 02Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "appendectomy" (unspecified if ongoing); "cholecystectomy" (unspecified if ongoing); "hysterectomy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "unknown", described as "Fulminantmyocarditis following coronavirus disease 2019 vaccination". The patient underwent the following laboratory tests and procedures: adenovirus test: (unspecified date) negative; alanine aminotransferase (8-45): (unspecified date) 167 IU/l; aspartate aminotransferase (2-40): (unspecified date) 323 IU/l; atrial pressure: (unspecified date) 45/32 mmHg; (unspecified date) 11 mmHg; biopsy: (unspecified date) revealed fulminant myocarditis, notes: with extensive myocyte damage out of proportion to the inflammatory infiltrates; blood albumin (3.2-4.6): (unspecified date) 4.1 g/dl; blood bilirubin (0.2-1.2): (unspecified date) 0.6 mg/dl; blood creatinine: (unspecified date) 2.05 mg/dl; blood creatinine (0.57-1.11): (unspecified date) 1.15 mg/dl; blood culture: (unspecified date) negative; blood lactic acid: (unspecified date) 5.8 mmol/L; blood pressure measurement: (unspecified date) 94/64 mmHg; blood sodium (135-145): (unspecified date) 133 mmol/L; brain natriuretic peptide (normal high range 265): (unspecified date) 1511 pg/mL; coronavirus test: (unspecified date) negative; coxsackie virus test: (unspecified date) negative; c-reactive protein (normal high range 8): (unspecified date) 37 mg/l; culture urine: (unspecified date) negative; cytomegalovirus test: (unspecified date) negative; electrocardiogram: (unspecified date) showed nonspecific st-segment and t wave abnormali, notes: and low voltage QRS complexes throughout; heart rate: (unspecified date) 98, notes: Beats per minute; hepatitis c: (unspecified date) negative; hiv test: (unspecified date) negative; human metapneumovirus test: (unspecified date) negative; influenza virus test: (unspecified date) negative; interleukin level: (unspecified date) 93.4 pg/mL; investigation: (unspecified date) negative; (unspecified date) 3.4, notes: Unit : lg/mL; (unspecified date) positive, notes: 1417 copies/mL; (unspecified date) negative; (unspecified date) negative; (unspecified date) negative; magnetic resonance imaging heart: (unspecified date) showed resolving myocarditis, notes: with normal biventricular function, persistent myocardial oedema, and significantly reduced burden of patchy mid-myocardial fibrosis in the LV; oxygen saturation: (unspecified date) 99 %; parvovirus b19 test: (unspecified date) negative; platelet count (140-440): (unspecified date) 158, notes: unit: thousand/mm3; polymerase chain reaction: (unspecified date) negative; procalcitonin (normal high range 0.5): (unspecified date) 0.16 ng/ml; pulmonary arterial wedge pressure: (unspecified date) 32 mmHg; red blood cell count (4-5.2): (unspecified date) 4.55, notes: Unit: million/mm3; respiratory syncytial virus test: (unspecified date) negative; sars-cov-2 test: (unspecified date) negative; (unspecified date) negative; sputum culture: (unspecified date) negative; stress echocardiogram: (2015) negative, notes: for ischaemia and showed normal left ventricular (LV) function; troponin i (normal high range 0.344): (unspecified date) 72.65 ng/ml; white blood cell count (4.5-11): (unspecified date) 5.2, notes: Unit: thousand/mm3. Therapeutic measures were taken as a result of myocarditis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . 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.