Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis; This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Myocarditis) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.      No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization prolonged and medically significant). The patient was hospitalized for 3 days due to MYOCARDITIS. At the time of the report, MYOCARDITIS (Myocarditis) outcome was unknown. Possible      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDITIS (Myocarditis) to be possibly related.    Concomitant product and treatment medication use was not provided by the reporter.  All cases occurred within 2 weeks of a dose of the COVID-19 mRNA vaccine with the majority occurring within 3 days (range 1-13 days) following the second dose (6/7 patients, 86%). Overall, cases were mild, and all patients survived.  Myocarditis was a rare adverse event associated with COVID-19 mRNA vaccines, and in adult males it occurs with significantly higher incidence than the background population rate. Recurrence of myocarditis after a subsequent mRNA vaccine dose was not known at this time.  Company Comment: This literature-study case concerns a 31-year-old male patient with no relevant medical history who experienced serious expected event of myocarditis. The event occurred 2 days after the second dose of the Moderna COVID-19 vaccine. Regarding clinical manifestation, the patient's only symptom reported was chest pain. No comorbidities were reported. The patient was hospitalized for 3 days due to the event. Per author, this case of myocarditis was mild and the patient received aspirin, lisinopril and metoprolol as a corrective treatment for the event. Patient's MRI was unremarkable 5 days after the onset. The event was considered resolved.  since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.   This case was linked to MOD-2021-380876, MOD-2021-380877, MOD-2021-380878 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This literature-study case concerns a 31-year-old male patient with no relevant medical history who experienced serious expected event of myocarditis. The event occurred 2 days after the second dose of the Moderna COVID-19 vaccine. Regarding clinical manifestation, the patient's only symptom reported was chest pain. No comorbidities were reported. The patient was hospitalized for 3 days due to the event. Per author, this case of myocarditis was mild and the patient received aspirin, lisinopril and metoprolol as a corrective treatment for the event. Patient's MRI was unremarkable 5 days after the onset. The event was considered resolved.  since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.