Age: 71.0
Sex: F
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 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: (privacy)    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 criterion medically significant). 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.    No concomitant information were reported. Treatment information was not provided.  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 71-year-old female patient with relevant medical history of hypertension and atrial fibrillation, who experienced serious expected event of myocarditis. The event occurred approximately 13 days after the second dose of the Moderna COVID-19 vaccine . The patient's initial symptoms were chest pain and diaphoresis. ECG showed inferolateral ST elevation whereas echocardiogram showed 52% EF and Takotsubo cardiomyopathy. The patient received Metoprolol and Colchicine as a corrective treatment for the event. The patient was hospitalized for two days and the event was later considered resolved. Rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and thus, recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.   This case was linked to MOD-2021-380819, MOD-2021-380876, MOD-2021-380877 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This literature-study case concerns a 71-year-old female patient with relevant medical history of hypertension and atrial fibrillation, who experienced serious expected event of myocarditis. The event occurred approximately 13 days after the second dose of the Moderna COVID-19 vaccine . The patient's initial symptoms were chest pain and diaphoresis. ECG showed inferolateral ST elevation whereas echocardiogram showed 52% EF and Takotsubo cardiomyopathy. The patient received Metoprolol and Colchicine as a corrective treatment for the event. The patient was hospitalized for two days and the event was later considered resolved. Rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and thus, recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.