Sex: M
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase, C-reactive protein, Chest X-ray, Echocardiogram, Electrocardiogram
Clinical narrative: myocarditis; This is a literature report for the following literature source(s): "Chest Pain in a 15-Year-Old Boy Following Administration of Second COVID-19 Vaccine Dose", A 15-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 and concomitant medications were not reported. Past drug history included: Covid-19 vaccine for Covid-19 immunisation, notes: DOSE 1, SINGLE. The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "recovering". The patient underwent the following laboratory tests and procedures: Blood creatine phosphokinase: Normal; Chest X-ray: Normal, notes: no acute findings; C-reactive protein: 3.05 mg/dl; Echocardiogram: Negative, notes: acute pericardial effusion or other structural or functional abnormalities. On Day 1 hospitalization; Electrocardiogram: Normal; showed ST elevation in leads II, III, and AVF, notes: with mild elevations in other leads. On Day 1 hospitalization; sinus rhythm with reported possible, notes: sinus rhythm with reported possible left ventricular hypertrophy; Full blood count: Normal; Haemoglobin: 17.8, notes: elevated; Red blood cell sedimentation rate: Normal; Troponin: 0.96 ng/L, notes: elevated; Troponin T: 626 ng/L, notes: On Day 1 hospitalization; 1051 ng/L, notes: On Day 2 hospitalization; began to downtrend, notes: On Day 3 hospitalization; 389 ng/L, notes: At the discharged day from hospitalization; White blood cell count: Normal. Therapeutic measures were taken as a result of myocarditis. Clinical course: Case Report: A 15-year-old boy with no previous medical history presented to a local emergency department 2 days after receiving his second dose of the Pfizer-BioNTech COVID-19 vaccine. History revealed that during the afternoon after he had received the second dose, the patient began feeling general malaise and chills that progressed into headaches. The following day, upon awaking, the patient developed dull, burning, substernal chest pain that radiated to the throat and ears that he described as tightness. The pain was alleviated by leaning forward and exacerbated by deep inspiration. He also had related numbness and tingling in his arms and hands. The patient attempted to relieve his symptoms with the use of acetaminophen, which resulted in mild improvement of symptoms. Persistence of symptoms despite acetaminophen usage prompted the patient to present to the hospital. While at the emergency department, he was afebrile and hemodynamically stable. Laboratory analysis with complete blood count (CBC), chest x-ray (CXR), and electrocardiogram (ECG) revealed normal white blood cell, elevated hemoglobin at 17.8, no acute findings on CXR, and sinus rhythm with reported possible left ventricular hypertrophy on ECG. Troponin was elevated at 0.96 ng/mL (This is a distinct use of the unit "ng/mL". Later values and C-reactive protein elevated at 3.05 mg/dL with normal erythrocyte sedimentation rate and normal creatine phosphokinase. He was then transferred for further inpatient management. Final Diagnosis: The final diagnosis was probable myocarditis in the setting of Pfizer-BioNTech COVID-19 vaccination. This patient reported signs and symptoms consistent with myocarditis, including new-onset chest pain and elevated troponins immediately after receiving the Pfizer-BioNTech COVID-19 vaccination. The diagnosis is based on clinical suspicion but was not confirmed with myocardial biopsy or cardiac magnetic resonance imaging.; Sender's Comments: Based on the information provided, and a temporal association, a causal association between reported event myocarditis  and suspect BNT162B2 cannot be excluded.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.