Sex: M
Vaccine: COVID19
Symptoms: Lymphocyte count, Magnetic resonance imaging heart, Myocarditis, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: Myocarditis; This is a literature report for the following literature source(s):   A 17-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: "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: MYOCARDITIS (hospitalization, medically significant, life threatening), 2 days after the suspect product(s) administration, outcome "recovered". The event "myocarditis" required emergency room visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram pelvis: negative for pulmonary embolism; C-reactive protein (0.1-1.7): 75 mg/l; 87 mg/l; Echocardiogram: demonstrated normal biventricular, notes: (cont'd) size/function and proximal coronary arteries; normal, notes: At the 10-day follow-up; Electrocardiogram: was consistent with myopericarditis, notes: demonstrated sinus tachycardia (heart rate =102 bpm), T-wave inversion in lateral leads, and diffuse ST-segment changes (ST-segment elevation in inferolateral leads and ST-segment depression in aVR and V1); Labs: had normal labs, notes: At the 10-day follow-up; Lymphocyte count (20-70): 15 %; Magnetic resonance imaging heart: was consistent with myocarditis, notes: late-gadolinium enhancement (LGE) at the left ventricular (LV) inferior wall, myocardial edema, and hyperemia at the mid-LV anterior wall; SARS-CoV-2 antibody test: negative; SARS-CoV-2 test: Negative; Troponin (normal high range 0.05): 8.1 ng/ml; 12.5 ng/ml; improved; White blood cell count (4.5-13.2): 12 x10 9/l. Therapeutic measures were taken as a result of myocarditis.  Clinical course: Patient presented to the emergency department (ED) with chest pain 2 days after receiving his second Pfizer-BioNTech COVID-19 vaccine. He initially developed fever, chills, malaise, myalgia, nausea, and vomiting, followed by sharp, central chest pain and dyspnea. The chest pain did not respond to albuterol or ibuprofen. There was no preceding upper respiratory infection (URI) or other gastrointestinal (GI) symptoms. No previous COVID-19 infection. Initial troponin was 8.1 ng/mL (normal <0.05 ng/mL). Nitroglycerin was ineffective and resulted in transient hypotension that self-resolved. He was transferred to our center, received 2 g/kg of intravenous immunoglobulin (IVIG) and was started on steroids and aspirin. Colchicine was added for ongoing chest pain, which provided symptomatic relief. As symptoms and troponin improved, aspirin was discontinued, and he was discharged after 6 days with exercise restrictions, a steroid taper, and colchicine for 2 weeks. At the 10-day follow-up, he had normal labs and echocardiogram.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug 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 product and on the conduct of the study 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.