Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, C-reactive protein, Cardiopulmonary exercise test, Cardiovascular examination
Clinical narrative: Myopericarditis with hemorrhagic pericardial effusion; Myopericarditis; chills again; intermittent fever; back pain; This is a literature report.  A 74-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "alcoholic cirrhosis" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "hospitalization" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PERICARDIAL EFFUSION (hospitalization, medically significant), 2 weeks after the suspect product(s) administration, outcome "recovered", described as "Myopericarditis with hemorrhagic pericardial effusion"; MYOPERICARDITIS (hospitalization, medically significant), 2 weeks after the suspect product(s) administration, outcome "recovered"; CHILLS (hospitalization), outcome "recovered", described as "chills again"; PYREXIA (hospitalization), outcome "recovered", described as "intermittent fever"; BACK PAIN (hospitalization), outcome "recovered". The patient underwent the following laboratory tests and procedures: Angiotensin converting enzyme: Negative; Antibody test: Negative; Antineutrophil cytoplasmic antibody: Negative; Bacterial test: Negative; Blood pressure measurement: 110/62 mmHg; Body temperature: 36.1 Centigrade, notes: degree celcius; Cardiopulmonary exercise test: normal; Cardiovascular examination: normal; Chest X-ray: clear lungs with no abnormality; Computerised tomogram abdomen: ruled out tumor masses; Computerised tomogram pelvis: ruled out tumor masses; Computerised tomogram thorax: ruled out tumor masses; it revealed new pericardial effusion; C-reactive protein: 247 mg/l; Cytology: did not show malignant cells; Echocardiogram: showed a large circumferential pericardial, notes: effusion without tamponade physiology; showed a small precordial effusion.; Electrocardiogram: new-onset atrial fibrillation and his chest X-ray, notes: (CXR) confirmed clear lungs with no abnormality; Epstein-Barr virus antibody: negative; Fungal test: negative; Gene sequencing: negative; Gram stain: Negative; Heart rate: 87, notes: beats/min; Hepatitis C virus core antigen: negative; Herpes virus test: negative; HIV test: negative; Imaging procedure: revealed no signs of active inflammation but it, notes: did show a small area of epicardial enhancement characteristic of prior myocarditis; Inflammatory marker test: elevated; Autoimmunity study: negative; revealed 201,000 red blood cells per mm^3, 2375 ce, notes: cells per mm 3 with 67% lymphocytes, negative Gram stain, and acid-fast bacilli; Negative; laboratory workup: showed mild leukocytosis; Lymphocyte count: 67 %; Magnetic resonance imaging: done to exclude possible infiltrative etiology of, notes: myopericarditis; Mycobacterium test: negative; Myocardial necrosis marker: normal; Nasopharyngeal swab: Negative; Oxygen saturation: 90, notes: percent on ambient air; Parvovirus B19 test: negative; Red blood cell count: 201000 /mm3, notes: per mm3; Respiratory rate: 16, notes: breaths/min; Serology test: negative; White blood cell agglutination present: 15000 /mm3, notes: cells/mm3. Therapeutic measures were taken as a result of pericardial effusion, myopericarditis, chills, pyrexia, back pain. Clinical course: He was given five doses of prednisone, but he did not show any improvements. The patient had no known COVID-19 exposures, history of recent viral illness, or other known risk factors. The patient was doing well for a week after discharge from the hospital until he started to have back pain, intermittent fever, and chills again. He was admitted again to the hospital, and repeated thoracic echocardiogram showed a small precordial effusion. Therefore, treatment with ibuprofen 600 mg three times a day and colchicine 0.5 mg twice a day was initiated. On a four-week follow-up, the patient reported a complete relief of chest pain. Both colchicine and ibuprofen were thus discontinued.  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 known safety profile and Limited information in the case report a casual association between reported events and the suspect drug BNT162B2 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