Sex: M
Vaccine: COVID19
Symptoms: Troponin I
Clinical narrative: Myocarditis; Myocardial edema; Pericardial effusion; This is a literature report.  A 17 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "recovering", described as "Myocarditis"; MYOCARDIAL OEDEMA (hospitalization, medically significant), outcome "recovering", described as "Myocardial edema"; PERICARDIAL EFFUSION (hospitalization, medically significant), outcome "recovering", described as "Pericardial effusion". The patient was hospitalized for myocarditis, myocardial oedema, pericardial effusion (hospitalization duration: 4 day(s)). The events "myocarditis", "myocardial edema" and "pericardial effusion" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: c-reactive protein: (unspecified date) 1.70 mg/dl; echocardiogram: (unspecified date) suspected myocarditis; (unspecified date) biventricular size: normal, notes: Biventricular function: Normal Additional findings: Ectasia of RCA and LAD; ejection fraction: (2021) 56 %; (2021) 54 %; electrocardiogram: (unspecified date) normal; investigation: (2021) 4, 5, 10, and 11; (2021) yes; (2021) yes; (2021) 86, notes: (mL/m2); (unspecified date) negative; (2021) 86, notes: (mL/m2); (unspecified date) negative; magnetic resonance imaging heart: (2021) lvef (%): 56, notes: RVEF (%): 54, LVEDV/BSA (mL/m2): 86,RVEDV/BSA (mL/m2): 86,Early gadolinium enhancement: Yes,Late gadolinium enhancement: Yes, Distribution of enhancement: 4, 5, 10, and 11,Myocardial edema: Yes,Pericardial effusion: Trace; sars-cov-2 test: (unspecified date) negative; troponin i: (unspecified date) 4.81 ng/ml. Therapeutic measures were taken as a result of myocarditis, myocardial oedema, pericardial effusion.  Clinical Information: Patient reported the onset of symptoms within 4 days of receiving the second dose of a COVID-19 mRNA vaccine. Patient had no known contact with a patient positive for SARS-CoV-2 infection. Patient not reported significant cardiovascular risk factors or a history of previous cardiovascular events. Patient did not undergo endomyocardial biopsy. Patient underwent echocardiography because of clinically suspected myocarditis. Patient not exhibited segmental wall motion abnormalities. The recurrent symptoms occurred after discontinuation of the NSAID that had been prescribed at discharge and recurrent symptoms resulted in an emergency department visit. Cardiac MRI showed both EGE and LGE. Functional assessment on cardiac MRI was concordant with echocardiography. The myocardial T2 signal intensity ratio was increased (> 1.8). Cardiac MRI findings were consistent with myocarditis in patient on the basis of the Lake Louise criteria, including early gadolinium enhancement and late gadolinium enhancement (LGE) in patient and corresponding myocardial edema. Troponin levels were elevated at initial presentation. Other potential major causes of myocarditis, aside from the recent vaccination, were deemed clinically unlikely in all patients on the basis of the absence of a significant medical history, a lack of contributory findings on physical examination, negative PCR result for SARS-CoV-2, and negative myocarditis viral panel. Biventricular size and right ventricular ejection fraction (RVEF) were normal. Patient showed involvement of the inferior, inferolateral, or anterolateral walls, showed EGE and LGE on cardiac MRI and showed basilar involvement. A possible causal association between COVID-19 mRNA vaccination and myocarditis has been report Myocarditis after COVID-19 vaccination is uncommon. However, its prevalence may be underestimated because of the reliance on symptoms for suspecting the diagnosis. The pathophysiology of myocarditis in the setting of COVID-19 is believed to in part relate to the cardio tropism of the SARS-CoV-2 spike protein. This protein is theorized to use the angiotensin-converting enzyme 2 receptors of cardiomyocytes for cell entry. Both the Moderna and Pfizer-BioNTech vaccines use mRNA sequences that encode the spike protein. If causality is established between the vaccines and myocarditis, the spike protein could potentially serve as a therapeutic target. All cardiac MRI examinations were performed using a 1.5-T magnet (Magnetom Sola, Siemens Healthcare). The protocol included the following sequences: axial and multiplanar cine precontrast SSFP, T1- and T2-weighted spectral adiabatic inversion recovery (SPAIR), perfusion imaging, early postcontrast short-axis SSFP, time inversion scout, and multiplanar T1-weighted inversion recovery segmented breath-hold late gadolinium enhancement (LGE) imaging. The LGE imaging was performed using IV administration of gadobenate dimeglumine. T1 and T2 parametric imaging was acquired at the discretion of the protocoling radiologist. For the scanner that performs cardiac MRI at the medical facility, normal reference native T1 parametric values were determined to be less than 1100 milliseconds, and normal T2 parametric values were determined to be less than 55 milliseconds. The readers initially compared cardiac functional assessment between MRI and echocardiography. The readers then assessed for individual findings associated with the diagnosis of myocarditis based on the updated 2018 Lake Louise criteria (LLC), which incorporate a combination of T1- and T2-based criteria. The T1- based criteria encompassed the presence of early gadolinium enhancement (EGE), presence of LGE, and increased T1 relaxation times. The T2-based criteria encompassed the presence of focal myocardial oedema, increased myocardial T2 signal intensity ratios, and increased T2 relaxation times. The readers also recorded the presence of a pericardial effusion and of pericardial enhancement. A pericardial effusion with the pericardial fluid width measuring less than 4 mm was characterized as trace, and a pericardial effusion with the pericardial fluid width measuring 45 mm was characterized as small. In addition, the readers evaluated the lung parenchyma and pleura for abnormalities on the axial SSFP sequence. Finally, the readers determined if the cardiac MRI examination was overall consistent with a diagnosis of myocarditis in consideration of the LLC. Cardiac MRI findings in patient with myocarditis in the setting of recent COVID-19 mRNA vaccination. Patient was male adolescent without known prior SARS-CoV-2 infection and patient had a favourable initial clinical course. Additional investigation is warranted to establish causality.  No follow-up attempts possible. No further information expected.; Sender's Comments: Based on the available information in the case, the causal association between the events myocarditis, myocardial edema, pericardial effusion and the suspect drug BNT162B2 cannot be excluded. 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.,Linked Report(s) : US-PFIZER INC-202200355287 Same drug/event and different patient