Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging heart, Malaise, Myalgia, Myocarditis, N-terminal prohormone brain natriuretic peptide
Clinical narrative: Acute myocarditis; Malaise; Dry cough; Myalgias; Headache; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Acute myocarditis) in a 44-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.   LITERATURE REFERENCE: Case report: acute myocarditis following the second dose of mRNA-1273 SARS-CoV-2 vaccine. Rep. 2021;5(8):1-6     The patient's past medical history included Smoker (former smoker). Concurrent medical conditions included Obstructive sleep apnoea syndrome, Asthma and Obesity (BMI 30.9 kg/m2). Concomitant products included ALBUTEROL [SALBUTAMOL] and FLUTICASONE; SALMETEROL for an unknown indication.   On 01-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYOCARDITIS (Acute myocarditis) (seriousness criteria hospitalization prolonged and medically significant). On an unknown date, the patient experienced MALAISE (Malaise), COUGH (Dry cough), MYALGIA (Myalgias) and HEADACHE (Headache). The patient was hospitalized from 05-May-2021 to 09-May-2021 due to MYOCARDITIS. The patient was treated with COLCHICINE on 06-May-2021 for Chest pain, at an unspecified dose and frequency. On 06-Jun-2021, MYOCARDITIS (Acute myocarditis) had resolved. At the time of the report, MALAISE (Malaise), COUGH (Dry cough), MYALGIA (Myalgias) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, Angiocardiogram: abnormal (abnormal) showed very mild coronary artery disease. On 05-May-2021, C-reactive protein: 63.5 mg/l (High) 63.5 mg/L (reference range: =8.0?mg/L). On 05-May-2021, Cardiac ventriculogram left: 40% (abnormal) showed a mildly reduced ejection fraction of 40% with global hypokinesis that was most severe at the apex. On 05-May-2021, Echocardiogram: abnormal (abnormal) Showed a decreased left ventricular ejection fraction.Demonstrated borderline enlarged left ventricle with an estimated ejection fraction of 4045%, mild-moderate generalized left ventricular hypokinesis, slightly worse at the apex, borderline enlarged right ventricle with mildly-moderately decreased systolic function, and no significant valve disease.. On 05-May-2021, Electrocardiogram: abnormal (abnormal) Electrocardiogram showed ST-segment elevation in the lateral limb and precordial leads. On 05-May-2021, Eosinophil count (0.03-0.48): 0.04 × 10(9)/l (normal) 0.04 × 10(9)/L. On 05-May-2021, Left ventricular end-diastolic pressure: 29?mmhg (High) markedly elevated at 29?mmHg. On 05-May-2021, Magnetic resonance imaging heart: acute myocarditis (abnormal) was compatible with acute myocarditis with patchy linear mid-myocardial enhancement of the septum and inferior walls at the base to mid-ventricle, sub-epicardial/mid-myocardial enhancement of the lateral wall at the mid-ventricle and apical lateral wall. There was associated myocardial oedema involving most of the myocardium and mild pericardial enhancement. On 05-May-2021, N-terminal prohormone brain natriuretic peptide: 1059 pg/ml (High) 1059 pg/mL (reference range: =51?pg/mL). On 05-May-2021, Physical examination: minimal lower extremity swelling (abnormal) showed minimal lower extremity swelling. On 05-May-2021, Red blood cell sedimentation rate (2-2): 12 mm/h (High) 12 mm/h. On 05-May-2021, Troponin T: 847 ng/l (High) 847 ng/L (reference range: =15?ng/L). On 05-May-2021, Vital signs measurement: normal (normal) temperature of 36.9 degrees Celsius, heart rate of 79 beats per minute, blood pressure of 90/72, respiratory rate of 12 breaths per minute, and oxygen saturation of 95%. On 05-May-2021, White blood cell count (3.4-9.6): 9.7 × 10(9)/l (High) 9.7 × 10(9)/L. On 06-May-2021, Echocardiogram: normal (normal) Repeat Transthoracic echocardiogram showing normalization of ejection fraction, and no regional wall motion abnormalities. On 06-May-2021, Troponin T: 675?ng/l (High) decreased to 675?ng/L the day after admission. On an unknown date, Chest X-ray: mild pulmonary oedema (abnormal) showed findings consistent with mild pulmonary oedema. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative (COVID-19 nasal swab testing using polymerase chain reaction was negative).     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDITIS (Acute myocarditis), MALAISE (Malaise), COUGH (Dry cough), MYALGIA (Myalgias) and HEADACHE (Headache) to be possibly related.    Patient was in his usual state of health prior to getting the second dose of mRNA-1273 SARS-CoV-2 Vaccine. There was no family history of cardiovascular or autoimmune disease.  Endomyocardial biopsy was not performed as the patient experienced mild symptoms, had no haemodynamic or electrical instability, and responded promptly to initial management.  The patient was started on supportive therapy for the symptoms, including a brief course of intravenous diuretics for mild symptoms of congestion. Angiotensin-converting enzyme inhibitor and a beta-blocker therapy were commenced to treat systolic dysfunction. The patient was also initiated on colchicine to treat mild persistent chest pain, which was thought to be related to pericardial inflammation that resolved 4-5?days after presentation.   The patient was discharged home after 5 days of monitoring without evidence of electrical or haemodynamic instability and with Class I symptoms. One month later, repeat echocardiogram showed normalization of the left ventricular ejection fraction (56%) and size, no regional wall motion abnormalities, and normal longitudinal peak systolic strain. The patient remained asymptomatic and off diuretics.  This case concerns a 44-year-old male patient with a history of Obstructive sleep apnoea syndrome, Asthma and Obesity, who experienced the serious expected event Myocarditis. The event occurred approximately 4 days after the second and most recent dose of mRNA-1273 Moderna vaccine. The event was considered related to the study drug per the reporter's assessment. The event is consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Follow up received by safety on 22-Sep-2021 included an Email with FTA received from team and does not contain any new information.; Sender's Comments: This case concerns a 44-year-old male patient with a history of Obstructive sleep apnoea syndrome, Asthma and Obesity, who experienced the serious expected event Myocarditis. The event occurred approximately 4 days after the second and most recent dose of mRNA-1273 Moderna vaccine. The event was considered related to the study drug per the reporter's assessment. The event is consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.