Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis, Pain in extremity, Pericarditis, Pyrexia, Tremor
Clinical narrative: Pericarditis; elevated left ventricular function; Myopericarditis; "small heart attack",type 2 myocardial infarction; "felt like his heart would explode", Felt like heart beating out of chest; ongoing chest pain; sweating (2nd dose); shakes (2nd dose); arm soreness (2nd dose); fever (felt hot); This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION ("small heart attack",type 2 myocardial infarction), CARDIAC DISCOMFORT ("felt like his heart would explode", Felt like heart beating out of chest), LEFT VENTRICULAR DYSFUNCTION (elevated left ventricular function), MYOCARDITIS (Myopericarditis) and PERICARDITIS (Pericarditis) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced HYPERHIDROSIS (sweating (2nd dose)), TREMOR (shakes (2nd dose)), PAIN IN EXTREMITY (arm soreness (2nd dose)) and PYREXIA (fever (felt hot)). On 04-Mar-2021, the patient experienced MYOCARDIAL INFARCTION ("small heart attack",type 2 myocardial infarction) (seriousness criteria hospitalization and medically significant), CARDIAC DISCOMFORT ("felt like his heart would explode", Felt like heart beating out of chest) (seriousness criterion hospitalization), LEFT VENTRICULAR DYSFUNCTION (elevated left ventricular function) (seriousness criterion hospitalization), MYOCARDITIS (Myopericarditis) (seriousness criteria hospitalization and medically significant) and CHEST PAIN (ongoing chest pain). On an unknown date, the patient experienced PERICARDITIS (Pericarditis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 04-Mar-2021 to 06-Mar-2021 due to CARDIAC DISCOMFORT and MYOCARDIAL INFARCTION, then until 06-Mar-2021 due to LEFT VENTRICULAR DYSFUNCTION, MYOCARDITIS and PERICARDITIS. The patient was treated with LISINOPRIL at an unspecified dose and frequency and CARVEDILOL at an unspecified dose and frequency. At the time of the report, MYOCARDIAL INFARCTION ("small heart attack",type 2 myocardial infarction), CARDIAC DISCOMFORT ("felt like his heart would explode", Felt like heart beating out of chest), LEFT VENTRICULAR DYSFUNCTION (elevated left ventricular function), MYOCARDITIS (Myopericarditis), PERICARDITIS (Pericarditis), HYPERHIDROSIS (sweating (2nd dose)), TREMOR (shakes (2nd dose)), PAIN IN EXTREMITY (arm soreness (2nd dose)) and PYREXIA (fever (felt hot)) outcome was unknown and CHEST PAIN (ongoing chest pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Troponin: 16 (High) Troponin was Peaked to 16 and returned to 6.8, 20X the normal amount of cardiac enzyme (troponin).. On an unknown date, Diabetes mellitus: negative (Negative) Negative. On an unknown date, Hypertension: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient had undergone tests WBC, HDB, PLT, Cholesterol, HDL, Triglycerides and Cardiac Enzymes (troponin peaked at over 16, returned to 6.8). Patient was tested negative for diabetes, hypertension and no blockages.  Patient did not had Covid-19 in the past including  heart problems, myocarditis and pericarditis. He stated that he was placed in the ICU for 2 nights and was released on the third day (06Mar2021). For discharge treatment medications he was prescribed lisinopril and carvedilol for 2 months. The caller stated that he still has ongoing chest pain.  Company comment: This case concerns a 34-year-old male patient with no reported medical history who experienced the unexpected event of hyperhidrosis, tremor and pain in the arm and the expected event of fever which occurred on the same day after the second dose of Spikevax and unexpected events of myocardial infarction, left ventricular dysfunction, cardiac discomfort, chest pain and expected events of myopericarditis and pericarditis 4 days post second vaccine dose. The rechallenge is not applicable as the events that occurred after the first dose were not reported for second dose. Causality assessment for the event was not provided by the reported. Myopericarditis, pericarditis and pyrexia are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report   This case was linked to MOD-2021-318862 (Patient Link).; Sender's Comments: This case concerns a 34-year-old male patient with no reported medical history who experienced the unexpected event of hyperhidrosis, tremor and pain in the arm and the expected event of fever which occurred on the same day after the second dose of Spikevax and unexpected events of myocardial infarction, left ventricular dysfunction, cardiac discomfort, chest pain and expected events of myopericarditis and pericarditis 4 days post second vaccine dose. The rechallenge is not applicable as the events that occurred after the first dose were not reported for second dose. Causality assessment for the event was not provided by the reported. Myopericarditis, pericarditis and pyrexia are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report