Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood creatine phosphokinase increased, Chest pain, Myocarditis, Pericarditis, Pleuritic pain
Clinical narrative: Myopericarditis presenting with Left Pleuritic Chest Pain & elevated CK & Troponin T with ECG evidence for Pericarditis; Myopericarditis presenting with Left Pleuritic Chest Pain & elevated CK & Troponin T with ECG evidence for Pericarditis; Chest Pain & elevated CK & Troponin T with ECG evidence for Pericarditis; Myopericarditis presenting with Left Pleuritic Chest Pain & elevated CK & Troponin T with ECG evidence for Pericarditis; Myopericarditis presenting with Left Pleuritic Chest Pain & elevated CK & Troponin T with ECG evidence for Pericarditis; Pericarditis; This is a spontaneous report from a contactable physician.   A 18-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation, Solution for injection, Batch/Lot Number: EW0167) via intramuscular route of administration, administered in Arm Left on 12Jun2021 12:00 at the age of (age at 18-years-old) as a single dose for covid-19 immunisation. The patient medical history was not reported. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient did not receive any vaccines within four weeks prior to the vaccination. Concomitant medications included ascorbic acid, biotin, tocopheryl acetate (BIOTIN GUMMY) 2 gummies once daily taken for hair, skin and nail biotin supplementation therapy, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported and patient was taking a workout supplement powder- less than 1 serving a day. Pre-Kaged muscle supplement. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation, Solution for injection, Batch/Lot Number: EW0167) via intramuscular route of administration, administered in Arm Left on 22May2021 (at the age of 18-years-old) as a single dose for covid-19 immunisation. It was reported that on 14Jun2021 17:00 the patient experienced myopericarditis presenting with Left Pleuritic Chest Pain & elevated CK & Troponin T with ECG evidence for Pericarditis. The patient visited emergency room and was hospitalised due to these events. The patient received Indomethacin & Colchicine as treatment drug. On unspecified date patient underwent lab tests and procedures which included elevated CK: unknown, pericarditis: ecg, troponin t: unknown. The patient was recovered from the events in 2021.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information provided and considering close temporal relationship, the causal association between the events Myocarditis, Pericarditis, Pleuritic pain, Chest pain, CK increased, Troponin T increased and the suspect drug cannot be completely excluded. The case will be reassessed further upon receipt of additional information. 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.