Sex: M
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate, Respiratory pathogen panel, SARS-CoV-2 test, Troponin T, Viral test
Clinical narrative: Giant Cell Myocarditis; The initial case was missing the following minimum criteria: [no patient]. Upon receipt of follow-up information on (03Jun2022), this case now contains all required information to be considered valid.   A 63-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "psoriasis" (unspecified if ongoing); "diabetes" (ongoing); "tobacco use" (ongoing); "fatigue" (unspecified if ongoing); "emergency department" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 Immunization, reaction(s): "Fever". The following information was reported: GIANT CELL MYOCARDITIS (hospitalization, medically significant, life threatening), outcome "recovered". The patient underwent the following laboratory tests and procedures: Biopsy heart: revealing lymphocytes, eosinophils, and giant cell, notes: s, confirming the diagnosis of GCM; Cardiac index: 1.8, notes: Units:  L/min per M2; Catheterisation cardiac: revealed elevated filling pressures, a cardiac, notes: index of 1.8 L/min per M2, and no obstructive coronary artery disease; revealed elevated filling pressures, a cardiac, notes: index of 1.8 L/min per M2, and no obstructive coronary artery disease; C-reactive protein: result unknown, notes: Before admission; 8.88 mg/dl, notes: At the time of admission; Echocardiogram: revealed an ejection fraction of 35%, biventricula, notes: r hypertrophy, and apical hypokinesis; Electrocardiogram: showed ST-segment elevation in the setting of, notes: clinical heart failure; Haemoglobin: 14.3 g/dl, notes: Before admission units: (1000/3x3); 12.8 g/dl, notes: At the time of admission; HIV test: Negative, notes: Before admission; result unknown, notes: At the time of admission; Influenza virus test: result unknown, notes: Before admission; Not detected, notes: At the time of admission; Not detectedX2, notes: Before admission; result unknown, notes: At the time of admission; workup: negative; negative workup for infectious etiology of, notes: myocarditis; Magnetic resonance imaging heart: revealing mildly depressed biventricular systolic, notes: function with areas of linear and transmural subepicardial delayed enhancement involving the inferior and septal apical walls compatible with myocarditis; Microscopy: revealed tubuloreticular inclusions; N-terminal prohormone brain natriuretic peptide: result unknown, notes: Before admission; 15646 pg/mL, notes: At the time of admission; Platelet count: 413, notes: Before admission; 361, notes: At the time of admission; Red blood cell sedimentation rate: result unknown, notes: Before admission units: mm/h; 33, notes: At the time of admission; Respiratory pathogen panel: Not detected, notes: Before admission; Not detected, notes: At the time of admission; SARS-CoV-2 test: Not detectedX2, notes: Before admission; Not detected, notes: At the time of admission; Troponin T: result unknown, notes: Before admission; 5816 ng/L, notes: At the time of admission; Viral test: Not detected, notes: Before admission; result unknown, notes: At the time of admission; Weight decreased: 20-pound unintentional weight loss., notes: Before admission; White blood cell count: 12.2, notes: Before admission units: (1000/3x3); 10, notes: At the time of admission. Therapeutic measures were taken as a result of giant cell myocarditis.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event gaint cell myocarditis and the suspect product BNT162b2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug 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.