Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein, Echocardiogram, Electrocardiogram, Laboratory test, Lymphocyte count
Clinical narrative: Myocarditis; This is a literature report for the following literature source(s):   A 16-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mild COVID-19 infection" (unspecified if ongoing), notes: 5 months before presentation. The patient's concomitant medications were not reported. The following information was reported: MYOCARDITIS (hospitalization, medically significant), 1 day after the suspect product(s) administration, outcome "recovering". The patient was hospitalized for myocarditis (hospitalization duration: 3 day(s)). The event "myocarditis" required emergency room visit. The patient underwent the following laboratory tests and procedures: C-reactive protein (0.1-1.7): 55 mg/l, notes: Peak; C-reactive protein (normal high range 8.1): 60 mg/l, notes: Initial; Echocardiogram: Showed normal biventricular size/function and, notes: proximal coronary arteries; Normal, notes: At the 2-week follow-up after discharge; Electrocardiogram: Normal; Normal, notes: At the 2-week follow-up after discharge; Labs: Normal, notes: At the 2-week follow-up after discharge; Lymphocyte count: 27 %; Magnetic resonance imaging heart: Consistent with myocarditis: hyperemia at the LV, notes: base and mid-LV, and a small focus of LGE at the mid-LV inferolateral segment; SARS-CoV-2 antibody test: Positive; SARS-CoV-2 antibody test (normal high range 0.8): 8.2; SARS-CoV-2 test: Negative; Positive, notes: had a mild COVID-19 infection 5 months before presentation; Troponin I (normal high range 0.05): 13.3 ng/ml, notes: Initial; 13.3 ng/ml, notes: Peak; Unknown results, notes: improved after treatment; White blood cell count: 7.4, notes: on presentation. Therapeutic measures were taken as a result of myocarditis.  Clinical course: Reported that, male patient presented to the ED with chest pain 3 days after receiving his first dose. He had a subjective fever 1 day after vaccination. The following day, he developed sharp left-sided chest pain, exacerbated by deep breathing, with radiation to the left upper extremity. There were no preceding URI or GI symptoms. As his symptoms and troponin improved, he was discharged with exercise restrictions, steroids, and aspirin after 3 days of hospitalization. At the 2-week follow-up, labs, ECG, and echocardiogram were normal. Aspirin was discontinued and he was placed on tapering dose of steroid.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event: "Myocarditis" and the suspect drug 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.,Linked Report(s) : US-PFIZER INC-PV202300023917 Same article/drug/event and different patient;US-PFIZER INC-202300056979 Same article/drug/event and different patient;