Sex: M
Vaccine: COVID19
Symptoms: Angiogram, Aspiration pleural cavity, Biopsy, Biopsy pericardium, Blood bilirubin
Clinical narrative: constrictive pericarditis; This is a literature report for the following literature source(s)  A 19-year-old male patient received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1 , SINGLE; UNKNOWN MANUFACTURER), for COVID-19 immunisation. The following information was reported: PERICARDITIS CONSTRICTIVE (hospitalization, medically significant), 2 weeks after the suspect product(s) administration, outcome "recovered", described as "constrictive pericarditis". The event "constrictive pericarditis" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Angiogram: pericardial thickening, notes: and effusion with moderate bilateral pleural effusions; Aspiration pleural cavity: demonstrated transudative fluid negative, notes: for malignancy and acid-fast bacteria; Biopsy: unremarkable; Biopsy pericardium: non-specific chronic inflammatory changes; Blood bilirubin: 3.9 mg/dl, notes: mildly elevated; Blood test: Negative; Catheterisation cardiac: was suggestive of constrictive physiology, notes: with near equalization of the left ventricular end-diastolic pressure (LVEDP 26 mmHg); Chest X-ray: borderline enlarged cardiac silhouette; Colonoscopy: unremarkable; C-reactive protein: 7.8 mg/dl; Echocardiogram: demonstrated left, notes: ventricular ejection fraction (LVEF) of 55%,; a normal LVEF (55%) and normal diastolic filling, notes: pressures; Ejection fraction: 55 %, notes: mild right ventricular dilatation, and a moderate sized 'jelly-like' pericardial effusion and E/A ratio of 2.33; 55 %; Electrocardiogram: showed sinus tachycardia with low-voltage QRS, notes: complexes; Endoscopy: unremarkable; Epstein-Barr virus antibody: 827 IU/ml, notes: Infectious disease suspected EBV viraemia to be reactivation with repeat titre resulting negative; 825 IU/ml; Fungal test: Positive; Gastrointestinal pathogen panel: Negative; Haemoglobin: 12.4 g/dl, notes: anaemia; Heart rate: 123, notes: units:beats/min; tachycardia; Histology: no evidence of amyloid, iron deposition, or, notes: opportunistic infection; Imaging procedure: ventricular interdependence; E/A ratio: 2.33; Negative; Negative; pulmonary artery: 32 mmHg, notes: and ventricular interdependence; Negative; elevated; Repeat infectious labs: without evidence of, notes: active histoplasmosis or EBV; Left ventricular end-diastolic pressure: 26 mmHg; Magnetic resonance imaging heart: demonstrated diffuse pericardial thickening, notes: and delayed gadolinium enhancement of the visceral and parietal surfaces; septal bounce and, notes: left ventricular tethering suggestive of constrictive pericarditis; Mycobacterium test: Negative; Mycoplasma test: Positive; Pathology test: showed chronic fibrosis, notes: without amyloid, iron deposits, or opportunistic infections; fibrotic tissue with mild to moderate patchy, notes: chronic inflammation and haemorrhage; physical exam: Negative, notes: for jugular vein distension pericardial rub, and extremity oedema; Polymerase chain reaction: Negative; Pulmonary arterial wedge pressure: 28 mmHg, notes: during inspiration; 28 mmHg; Red blood cell sedimentation rate: 22, notes: units:mm/h; Respiratory rate: 26, notes: units:breaths/min; tachypnoea; Ultrasound scan: which demonstrated cholelithiasis, ascites, notes: and a right pleural effusion; Urine antigen test: Negative. Therapeutic measures were taken as a result of pericarditis constrictive.; Sender's Comments: Based on the information provided in the narrative, a causal association between the event Constrictive Pericarditis and the suspect drug cannot be completely 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.