Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Enterovirus test, Epstein-Barr virus test, Human herpes virus 6 serology, Influenza virus test
Clinical narrative: COVID vaccine-associated myocarditis; The initial case was missing the following minimum criteria: ICH-Unspecified product. Upon receipt of follow-up information on 21Sep2023 this case now contains all required information to be considered valid.  This is a literature report for the following literature source.  A previously healthy 8-year-old male presented to his paediatrician's office with chest pain and palpitations 2 days after receiving the second dose of the BNT162b2-mRNA (Pfizer-BioNTech) COVID vaccine. He had no prior medical conditions or surgeries, was on no medications, and had no pertinent cardiac family history. He had no known history of prior COVID infection. Electrocardiogram and chest X-ray were obtained at this visit and were within normal limits. However, a troponin was obtained and elevated to 7.94 (normal < 0.03 ng/mL), prompting referral to the Emergency Department for further evaluation. There, the patient had normal vital signs and an unremarkable physical exam. His biochemistry revealed an elevated high sensitivity troponin-I (6770, 6890, and 7094 ng/L at 0, 1, and 3 hours, respectively; normal < 59 ng/L) and an elevated NT-pro brain-natriuretic peptide to 396 pg/mL (normal < 125 pg/mL). His electrocardiogram remained normal without ST segment changes, and a bedside echocardiogram showed normal biventricular function and no pericardial effusion. The patient was started on ibuprofen and admitted to the hospital for observation with a clinical diagnosis of myocarditis. An extensive workup for an infectious aetiology of myocarditis was negative (including influenza, adenovirus, human herpesvirus 6, cytomegalovirus, Ebstein-Barr virus, enterovirus, parvovirus, and tuberculosis). He did not have any rhythm abnormalities on telemetry during this hospitalisation and did not require ICU-level care or inotropic support. He was discharged on hospital day three following resolution of chest pain and with down-trending high-sensitivity troponin-I (690 ng/L at discharge). The patient re-presented to the Emergency Department 5 days after discharge for recurrent and substernal chest pain. Troponin at that time was normal; his pain had resolved at onemonth follow-up visit. His electrocardiogram remained normal, as well as his function by echocardiography. He was instructed to forego any further mRNA COVID-19 vaccinations and to self-limit physical activity for a period of 3 months until his next follow-up visit. Discussion: this patient was only mildly symptomatic and was stable for discharge within 3 days of hospitalisation with down-trending troponins and resolution of symptoms using only ibuprofen. This disease course and rapid recovery seen in this patient parallels additional case reports detailing COVID vaccine-associated myocarditis in other paediatric and adult age groups. Myocarditis in the young has a bimodal age distribution, with peaks during infancy and adolescence, and an incidence gradually rising starting in preschool age children.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A possibly contributory role of BNT162B2 in triggering the onset of myocarditis cannot be fully excluded, considering the temporal relationship and known safety profile of the suspect vaccine.  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