Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza virus test, Myocarditis, Nausea, Oedema peripheral, Orthopnoea
Clinical narrative: Acute myocardial injury/ Myocarditis; MIS-A; Hypertensive; Worsening shortness of breath; Orthopnea; Fever; Chills; Nausea; Increasing fatigue; acute exacerbation of CHF; hypoxia; tachycardia; tachypnea; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Acute myocardial injury/ Myocarditis), SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (MIS-A), HYPERTENSION (Hypertensive), DYSPNOEA (Worsening shortness of breath), ORTHOPNOEA (Orthopnea), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), FATIGUE (Increasing fatigue), CONDITION AGGRAVATED (acute exacerbation of CHF), HYPOXIA (hypoxia), TACHYCARDIA (tachycardia) and TACHYPNOEA (tachypnea) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE:  Acute myocardial injury following COVID-19 vaccination: a case report and review of current evidence from vaccine adverse events reporting system database.  The patient's past medical history included Stent placement and Coronary artery bypass graft. Concurrent medical conditions included Hypertension, Type 2 diabetes mellitus, Hyperlipidemia, Coronary artery disease, Congestive heart failure (with preserved ejection fraction), Chronic obstructive pulmonary disease (without any home oxygen requirement), Hypothyroidism and Gastroesophageal reflux disease. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), ATORVASTATIN, CLOPIDOGREL, FUROSEMIDE, ISOSORBIDE MONONITRATE, LEVOTHYROXINE, LISINOPRIL, METFORMIN, METOPROLOL TARTRATE, POTASSIUM CHLORIDE, SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) and TIOTROPIUM for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Acute myocardial injury/ Myocarditis) (seriousness criteria hospitalization prolonged and medically significant), SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (MIS-A) (seriousness criteria hospitalization prolonged and medically significant), HYPERTENSION (Hypertensive) (seriousness criterion hospitalization prolonged), DYSPNOEA (Worsening shortness of breath) (seriousness criterion hospitalization prolonged), ORTHOPNOEA (Orthopnea) (seriousness criterion hospitalization prolonged), PYREXIA (Fever) (seriousness criterion hospitalization prolonged), CHILLS (Chills) (seriousness criterion hospitalization prolonged), NAUSEA (Nausea) (seriousness criterion hospitalization prolonged), FATIGUE (Increasing fatigue) (seriousness criterion hospitalization prolonged), CONDITION AGGRAVATED (acute exacerbation of CHF) (seriousness criterion hospitalization prolonged), HYPOXIA (hypoxia) (seriousness criteria hospitalization prolonged and medically significant), TACHYCARDIA (tachycardia) (seriousness criterion hospitalization prolonged) and TACHYPNOEA (tachypnea) (seriousness criterion hospitalization prolonged). The patient was hospitalized from sometime in 2021 to sometime in 2021 due to CHILLS, CONDITION AGGRAVATED, DYSPNOEA, FATIGUE, HYPERTENSION, HYPOXIA, MYOCARDITIS, NAUSEA, ORTHOPNOEA, PYREXIA, SYSTEMIC INFLAMMATORY RESPONSE SYNDROME, TACHYCARDIA and TACHYPNOEA. The patient was treated with FUROSEMIDE (intravenous) for Adverse event, at an unspecified dose and frequency; HYDRALAZINE for Adverse event, at an unspecified dose and frequency; CEFTRIAXONE for Sepsis, at an unspecified dose and frequency; AZITHROMYCIN for Sepsis, at an unspecified dose and frequency; Physical therapy (BiPAP (12/8 cm H2O setting)) for Dyspnoea and Physical therapy (BiPAP (12/8 cm H2O setting)) for Hypoxia. At the time of the report, MYOCARDITIS (Acute myocardial injury/ Myocarditis), SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (MIS-A), HYPERTENSION (Hypertensive), DYSPNOEA (Worsening shortness of breath), ORTHOPNOEA (Orthopnea), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), FATIGUE (Increasing fatigue), CONDITION AGGRAVATED (acute exacerbation of CHF), HYPOXIA (hypoxia), TACHYCARDIA (tachycardia) and TACHYPNOEA (tachypnea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood bilirubin: 1.9 (High) mg/100mL. In 2021, Blood culture: negative (Negative) negative. In 2021, Blood gases: abnormal (abnormal) pH 7.294, HCO3 21 mmole/L, PaCO2 39.9mmHg. In 2021, Blood lactate dehydrogenase (135-225 units/l): 239 (High) units/L. In 2021, Blood lactic acid: 5.7 (High) mmol/L. In 2021, Blood potassium: low (Low) hypokinesis of the ventricular wall in 2 regions on TTE with an acute presentation. In 2021, Brain natriuretic peptide (Unknown-124 pg/ml): elevated (High) 43134 pg/mL, elevated (High) 39813 pg/mL and elevated (High) 4796 pg/mL. In 2021, Breath sounds: abnormal (abnormal) coarse crackles in both lung bases. In 2021, C-reactive protein (0-0.5mg/dl): elevated (High) elevated 15.5 mg/dL and elevated (High) 11.5. In 2021, Chest X-ray: abnormal (abnormal) cardiomegaly and pulmonary edema without any focal conslidation. In 2021, Echocardiogram: abnormal (abnormal) mildly dilated left atrium, a left ventricle ejection fraction of 50%-54%, mild hypokinesia in the mid-septal and mid-anterior walls and grade 2 diastolic dysfunction. In 2021, Electrocardiogram: abnormal (abnormal) sinus tachycardia with non-specific ST/T wave cganges. In 2021, Fibrin degradation products (Unknown-500 ng/ml): 2010 (High) ng/mL. In 2021, Haemoglobin: 18 (High) g/dL. In 2021, Influenza virus test: negative (Negative) negative. In 2021, Oedema peripheral: 1+ (High) pitting edema in his lower extremities. In 2021, Oxygen saturation: 86% (Low) on lL/min of oxygen via nasal canula. In 2021, Red blood cell sedimentation rate (0-20 mm/h): elevated esr (High) 41 mm/h and 34 (High) mm/h. In 2021, Respiratory rate: 40 breaths/min (High) tachypneic. In 2021, SARS-CoV-2 test: negative (Negative) negative. In 2021, Serum ferritin (30-400 ng/dl): 550 (High) ng/dL and 454 (High) ng/dL. In 2021, Sputum culture: negative (Negative) negative. In 2021, Troponin (Unknown-19ng/l): 180.8 ng/l (High) elevated high sensitivity troponin, 117 (High) ng/dL and 85.2 (High) ng/dL. In 2021, Urine analysis: normal (normal) normal. In 2021, Venous pressure jugular: elevated (High) elevated. In 2021, Vital signs measurement: high (High) BP, mmHg= 169/96 HR, beats/min=141 Temperature (degree F)=101.2 RR, breaths/min= 26 oxygen saturation, %; oxygen requirement=92% 15L oxygen by NRB mask, high (High) BP, mmHg= 134/61 HR, beats/min=92 Temperature (degree F)=98.6 RR, breaths/min= 21 oxygen saturation, %; oxygen requirement=99%; BiPAP (12/8); 40% FiO2 and borderline (Borderline) BP, mmHg= 129/73 HR, beats/min=87 Temperature (degree F)=98.3 RR, breaths/min= 22 oxygen saturation, %; oxygen requirement=96%; 2L/min by NC. In 2021, White blood cell count: 17.86 x 1000/µl (High) leukocytosis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (Acute myocardial injury/ Myocarditis), SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (MIS-A), HYPERTENSION (Hypertensive), DYSPNOEA (Worsening shortness of breath), ORTHOPNOEA (Orthopnea), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), FATIGUE (Increasing fatigue), CONDITION AGGRAVATED (acute exacerbation of CHF), HYPOXIA (hypoxia), TACHYCARDIA (tachycardia) and TACHYPNOEA (tachypnea) to be possibly related.    Patient denied history of previous COVID infection or contact with a patient with known COVID-19 infection. Acute exacerbation of CHF was treated with diuretics and supplemental oxygen therapy. Tachycardia and Tachypnea improved with bronchodilators.  A literature case with some reported events approximately 6 hours after the second dose of vaccine. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Probable confounding factors are the patient's medical history of  Hypertension, Type 2 diabetes mellitus, Hyperlipidemia, Coronary artery disease, and Congestive heart failure, with procedural history of Stent placement and Coronary artery bypass graft.; Sender's Comments: A literature case with some reported events approximately 6 hours after the second dose of vaccine. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Probable confounding factors are the patient's medical history of  Hypertension, Type 2 diabetes mellitus, Hyperlipidemia, Coronary artery disease, and Congestive heart failure, with procedural history of Stent placement and Coronary artery bypass graft.