Sex: M
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate, Respiratory rate, SARS-CoV-2 test, Troponin I, White blood cell count
Clinical narrative: Focal myocarditis associated with the Pfizer-BioNTech COVID-19 vaccine/peri-myocarditis associated with vaccination against COVID-19; This is a literature report for the following literature source(s).  A 24-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: "seizure disorder" (unspecified if ongoing); "denies any tobacco use" (unspecified if ongoing); "vagal nerve stimulator" (unspecified if ongoing). Concomitant medication(s) included: LEVETIRACETAM; OXCARBAZEPINE. Vaccination history included: Pfizer-biontech vaccine (Dose 1, single), for COVID-19 immunization. The following information was reported: MYOPERICARDITIS (hospitalization, medically significant), 3 days after the suspect product(s) administration, outcome "recovered", described as "Focal myocarditis associated with the Pfizer-BioNTech COVID-19 vaccine/peri-myocarditis associated with vaccination against COVID-19". The patient was hospitalized for myopericarditis (hospitalization duration: 3 day(s)). The event "focal myocarditis associated with the pfizer-biontech covid-19 vaccine/peri-myocarditis associated with vaccination against covid-19" required emergency room visit.The patient underwent the following laboratory tests and procedures: Antibody test: Negative; Negative; Blood pressure measurement: 129/77 mmHg; Body temperature: 37.2 Centigrade; Catheterisation cardiac: where he was found to have no significant coronary, notes: disease and a right coronary artery fistula to the coronary vein, felt to be an incidental finding; C-reactive protein: 4.9 mg/dl, notes: elevated; Echocardiogram: showed an ejection fraction, notes: of 45% and focal hypokinesis of the apical inferior wall; Echovirus test: Negative; Electrocardiogram: On arrival, showed normal sinus rhythm with, notes: concave upward ST segment elevation in leads II, III, aVF, and V4-V6. There was ST depression in lead aVR and subtle ST depression in leads VII and VIII. Spodick's sign (a down-sloping of the TP segment commonly seen in pericarditis) was also present as well as PR depression. No prior ECG was available for comparison; was largely unchanged, notes: repeat; Heart rate: 78, notes: beats per minute; revealed no abnormalities; Influenza virus test: Negative; abdomen examination: revealed no abnormalities; revealed no abnormalities; revealed no abnormalities; Oxygen saturation: 100 %, notes: on room air; physical examination: appears anxious but is in no distress; Polymerase chain reaction: Negative; Red blood cell sedimentation rate: 5, notes: mm/h normal; Respiratory rate: 18, notes: breaths per minute; SARS-CoV-2 test: Negative; Troponin I (normal high range 0.04): 9.01 ng/ml; 14.70 ng/ml, notes: repeat test; 24.42 ng/ml, notes: peaked on hospital day 2; White blood cell count (4000-10000): 14200 cells/uL. peutic measures were taken as a result of myopericarditis.  Clinical course: A 24-year-old male with a past medical history of seizure disorder presented to the emergency department with a chief complaint of chest pain. The patient woke up in the morning and noted chest pain radiating to his left arm with associated left arm tingling. He did an internet search and was alerted he had symptoms of a heart attack and presented to the emergency department. He had no personal history of coronary disease, hypertension, diabetes, or dyslipidemia. He has no family history of early cardiac disease or sudden death. He had no diagnosed psychiatric conditions, but he believes he may have undiagnosed anxiety. He denies any tobacco use, recent substance abuse, or life stressors. His medications include levetiracetam and oxcarbazepine, and he also has a vagal nerve stimulator. His review of symptoms was negative, including no fever, cough, dyspnea, nausea, vomiting, or sweating. He has not had any recent sick contacts or significant trauma. He received his second Pfizer-BioNTech COVID-19 vaccine 3 d ago. On physical examination, the patient appears anxious but is in no distress. His vital signs included a heart rate of 78 beats per minute, respiratory rate of 18 breaths per minute, blood pressure of 129/77 mmHg (1 mmHg equal to 0.133 kPa), oral temperature of 37.2 centigrade, and oxygen saturation (SpO2) of 100% on room air. His heart, lung, abdomen, and pulse examination revealed no abnormalities. The inspection and palpation of the chest was normal. On arrival, an electrocardiogram (ECG) was obtained. ECG showed normal sinus rhythm with concave upward ST segment elevation in leads II, III, aVF, and V4-V6. There was ST depression in lead aVR and subtle ST depression in leads VII and VIII. Spodick's sign (a down-sloping of the TP segment commonly seen in pericarditis) was also present as well as PR depression. No prior ECG was available for comparison. The patient was discussed with the cardiology department at the local referral hospital. The cardiologist recommended transfer for urgent catheterization to rule out occlusive coronary artery disease. The patient was given 324 mg of aspirin, started on a heparin infusion, and transferred to the referral center. In the meantime, labs resulted and were significant for a troponin I level of 9.01 ng/mL (normal less than 0.04 ng/mL) and a white blood cell count of 14,200 cells/uL (normal 4,000-10,000 cells/uL). The patient arrived at the outside hospital, and a repeat ECG was obtained, which was largely unchanged. His repeat troponin I was 14.70 ng/mL. The patient was taken for cardiac catheterization where he was found to have no significant coronary disease and a right coronary artery fistula to the coronary vein, felt to be an incidental finding. Echocardiography showed an ejection fraction of 45% and focal hypokinesis of the apical inferior wall. The patient was diagnosed with myopericarditis and admitted to the hospital. Magnetic resonance imaging (MRI) was contraindicated due to the presence of his vagal nerve stimulator, and both MRI and endomyocardial biopsy were considered unnecessary given the clear clinical picture. His troponin I peaked at 24.42 ng/mL on hospital day 2. His C-reactive protein (CRP) was elevated at 4.9 mg/dL, and his erythrocyte sedimentation rate (ESR) was normal at 5 mm/h. He was started on oral colchicine 0.6 mg. He then had a serum "myocarditis panel" for antibodies to Coxsackievirus, Echovirus, Influenza, and Chlamydia pneumoniae, all of which were negative. He also had a nasopharyngeal multiplex polymerase chain reaction (PCR) respiratory viral panel that was negative and a separate negative COVID-19 PCR test. He was discharged on hospital day 3 with no significant chest pain for over 24 h with a diagnosis of vaccine-associated myocarditis. Author present a case of focal myocarditis following mRNA vaccination for COVID-19. Myocarditis is a known rare complication of mRNA vaccination, but this risk is significantly lower than the risk of myocarditis following COVID-19 infection. Although it is highly likely, causation with the vaccine cannot be proven.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile and close temporal association, the event peri-myocarditis assessed as related to the use of suspect product BNT162b2. The case will be reassessed once further information is available. 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 RAs, Ethics Committees, and Investigators, as appropriate.