Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary arterial pressure, Pulmonary arterial wedge pressure, Red blood cell sedimentation rate, Troponin I, Ventricular tachycardia
Clinical narrative: Cardiogenic shock; Myocarditis; Ventricular tachycardia; This literature-non-study case was reported in a literature article and describes the occurrence of CARDIOGENIC SHOCK (Cardiogenic shock), MYOCARDITIS (Myocarditis) and VENTRICULAR TACHYCARDIA (Ventricular tachycardia) in a 55-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   LITERATURE REFERENCE:  The patient's past medical history included Right ventricular dysfunction.  On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIOGENIC SHOCK (Cardiogenic shock) (seriousness criteria hospitalization, medically significant and life threatening) and MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization, medically significant and life threatening). an unknown date, the patient experienced VENTRICULAR TACHYCARDIA (Ventricular tachycardia) (seriousness criteria hospitalization, medically significant and life threatening). The patient was hospitalized for 15 days due to MYOCARDITIS and VENTRICULAR TACHYCARDIA. The patient was treated with METHYLPREDNISOLONE (intravenous) at a dose of 40-400 mg; DOBUTAMINE at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, CARDIOGENIC SHOCK (Cardiogenic shock), MYOCARDITIS (Myocarditis) and VENTRICULAR TACHYCARDIA (Ventricular tachycardia) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Activated partial thromboplastin time (23.8-36.2 Second): 145.5 Second. On an unknown date, Angiocardiogram: No evidence of coronary disease. On an unknown date, Atrial pressure: 11 mmHg. On an unknown date, Blood creatinine: 0.92 mg/dl. On an unknown date, Blood pressure systolic: 88 mmHg. On an unknown date, Body mass index: 23.7. On an unknown date, Body surface area: 1.9 square metre. On an unknown date, C-reactive protein (0.0-10.0 milligram per litre): 94.2 milligram per litre. On an unknown date, Cardiac index: 1.69 litre per minute per square metre. On an unknown date, Echocardiogram: Global hypokinesis, Left ventricular ejection fraction 30%, Global Longitudinal Strain7.4 LV mass 111gm (57gm/M2). On an unknown date, Electrocardiogram: T-wave inversion in inferior and lateral leads. On an unknown date, Fibrin D dimer (Unknown-500 ng/mL): 653 ng/mL drawn prior to being placed on ECMO. On an unknown date, Haemoglobin: 12.7 g/dL. On an unknown date, Heart rate: 81 81 bpm. On an unknown date, Magnetic resonance imaging heart: Unable to administer gadolinium, increased T1 and T2 native parametric values suggestive of an inflammatory process, LVEF (Left ventricular ejection fraction) 48%. On an unknown date, Nasopharyngeal swab: Negative. On an unknown date, Platelet count (150-400 microliter): 99 microliter. On an unknown date, Prothrombin time (11.1-13.7 Second): 28.1 Second. On an unknown date, Pulmonary arterial pressure: 25 mmHg. On an unknown date, Pulmonary arterial wedge pressure: 20 mmHg. On an unknown date, Red blood cell sedimentation rate (0-10 mm/hr): 21 mm/hr. On an unknown date, Troponin I: 11456 ng/L and 24.80 ng/mL. On an unknown date, White blood cell count: 11.4 10^9/L.  The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered CARDIOGENIC SHOCK (Cardiogenic shock), MYOCARDITIS (Myocarditis) and VENTRICULAR TACHYCARDIA (Ventricular tachycardia) to be related.    Concomitant medications were not reported. Patient had symptoms of Chest pain, SOB, palpitations  .  Arrhythmias during hospitalization was given sustained VT   Patient had areas of focal punctate LGE on the initial study that were diminished but still present >1 month later.  Patient was treated with venoarterial extracorporeal membrane oxygenation (ECMO) for 1 week and clinically stabilized.  Patient was developed severe LV dysfunction and incipient cardiogenic shock 5 days after her first dose of mRNA vaccine and was considered too unstable for EMBx.  Author investigated 7 COVID-19 and 6 post-mRNA vaccination patients with myocardial injury and found nearly identical alterations in gene expression that would predispose to inflammation, coagulopathy, and myocardial dysfunction. In summary, it appears that histopathologic findings in myocardial injury associated with COVID-19 or mRNA vaccine can be due to causes other than myocarditis.  EMBx or CMR was 21 (20), days since vaccination (Vax) or onset of chest pain (CP)   This case belonged to case 2 from table S4.  Company comment: This is a literature non-study case concerning a 55 year-old, female patient with a history of Right ventricular dysfunction, who experienced the serious (due to medically important condition, life-threatening and hospitalization) unexpected, AESIs of Cardiogenic shock and myocarditis, which occurred 5 days after the first dose of mRNA-1273 vaccine. Patient reported symptoms of chest pain, shortness of breath, palpitations, she developed severe LV dysfunction and incipient cardiogenic shock 5 days after vaccination and was considered too unstable for endomyocardial biopsy. Nasal swab for SARS-CoV-2 was negative. Coronary angiogram showed no evidence of coronary disease. Echocardiogram found global hypokinesis, LVEF 30% and Electrocardiogram T-wave inversion in inferior and lateral leads. Laboratory tests showed D-dimer elevated 653 ng/mL (normal <500 ng/mL), Peak CRP at 94.2 mg/L (0.0  10.0 mg/L) and Peak troponin I: 24.8 ng/mL. Patient was treated with high-dose methylprednisolone, dobutamine, and venoarterial extracorporeal membrane oxygenation (ECMO) for 1 week and clinically stabilized. While on ECMO treatment Platelet nadir was 99/ µl (normal 150  400 µl) without bleeding being reported. During hospitalization sustained ventricular tachycardia (AESI) was reported. After ECMO discontinuation, cardiac magnetic resonance (CMR) without gadolinium infusion demonstrated increased T1 and T2 native parametric values suggesting myocardial edema consistent with an inflammatory process and myocarditis, with an LVEF of 48%. She continued to improve and was discharged 15 days after. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  This case was linked to US-MODERNATX, INC.-MOD-2022-670433, US-MODERNATX, INC.-MOD-2022-670443, US-MODERNATX, INC.-MOD-2022-670444, US-MODERNATX, INC.-MOD-2022-668401 (Linked Report).; Sender's Comments: Company Comment: This is a literature non-study case concerning a 55 year-old, female patient with a history of Right ventricular dysfunction, who experienced the serious (due to medically important condition, life-threatening and hospitalization) unexpected, AESIs of Cardiogenic shock and myocarditis, which occurred 5 days after the first dose of mRNA-1273 vaccine. Patient reported symptoms of chest pain, shortness of breath, palpitations, she developed severe LV dysfunction and incipient cardiogenic shock 5 days after vaccination and was considered too unstable for endomyocardial biopsy. Nasal swab for SARS-CoV-2 was negative. Coronary angiogram showed no evidence of coronary disease. Echocardiogram found global hypokinesis, LVEF 30% and Electrocardiogram T-wave inversion in inferior and lateral leads. Laboratory tests showed D-dimer elevated 653 ng/mL (normal <500 ng/mL), Peak CRP at 94.2 mg/L (0.0  10.0 mg/L) and Peak troponin I: 24.8 ng/mL. Patient was treated with high-dose methylprednisolone, dobutamine, and venoarterial extracorporeal membrane oxygenation (ECMO) for 1 week and clinically stabilized. While on ECMO treatment Platelet nadir was 99/ µl (normal 150  400 µl) without bleeding being reported. During hospitalization sustained ventricular tachycardia (AESI) was reported. After ECMO discontinuation, cardiac magnetic resonance (CMR) without gadolinium infusion demonstrated increased T1 and T2 native parametric values suggesting myocardial edema consistent with an inflammatory process and myocarditis, with an LVEF of 48%. She continued to improve and was discharged 15 days after. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-670443:34-YO-Male US-MODERNATX, INC.-MOD-2022-670444:21-YO-Male US-MODERNATX, INC.-MOD-2022-670433:26-YO-Male US-MODERNATX, INC.-MOD-2022-668401:23-YO-Female