Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Myocarditis, Pyrexia
Clinical narrative: Myocarditis; fever; chills; body aches; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Myocarditis) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.       No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches). At the time of the report, MYOCARDITIS (Myocarditis), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (Myocarditis), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches) to be possibly related.    No concomitant medication was reported.  No treatment details were provided.  Company comment: This is a literature non-study case concerning a 24-year-old, male patient with no reported medical history, who experienced the serious (due to medically significant) unexpected AESI of Myocarditis. The event occurred approximately 4 days after the second dose of mRNA-1273 vaccine. The patient's electrocardiogram demonstrated a sinus rhythm without ischemic changes. Laboratory studies revealed: elevated troponin I (18.94ng/mL, normal 0.01- 0.04), elevated Creatine Kinase (704 U/L, normal 49-348), elevated C Reactive Protein (26.4 mg/L, normal. A transthoracic echocardiogram 4 days post vaccination was within normal limits, the left ventricular ejection fraction (LVEF) was 65%. No focal wall motion abnormality was seen. Computed tomographic angiography of the coronary arterial system 5 days post vaccination demonstrated a calcium score of 0 without coronary artery stenosis and small bilateral pleural effusions. Cardiac MRI with gadolinium 5 days post-vaccination demonstrated normal LV size and EF (58%), patchy mid-myocardial and epicardial delayed gadolinium enhancement (Fig. 1), with superimposed edema, fulfilling the Lake Louise Criteria for myocarditis. The outcome of the event was not reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-223812 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Upon internal review on 02-Aug-2023, significant correction was performed to upgrade the event Myocarditis to serious medically significant. On 28-Jun-2021: Follow up received by safety 30-Jun-2021 included a no newinformation. On 29-Jun-2021: Follow up received by safety 30-Jun-2021 included a full text article received.