Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin I
Clinical narrative: Cardiogenic shock; acute fulminant myocarditis; chills; diaphoresis; Fatigue; Fevers; headache; generalised malaise; This literature-non-study case was reported in a literature article and describes the occurrence of CARDIOGENIC SHOCK (Cardiogenic shock) and MYOCARDITIS (acute fulminant myocarditis) in a 38-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: Imaging and histopathology in a young man presenting with fulminant lymphocytic myocarditis and cardiogenic shock after mRNA-1273 vaccination.      Concurrent medical conditions included Glioblastoma multiforme (2018. CT scan of the head showed a 6 cm × 5 cm right temporal mass, which was resected. The pathology was consistent with GBM, WHO grade IV. He was treated with 24 cycles of Temodar from 2018 to 2020 and initiated on Optune therapy, which has continued up until and beyond his presentation with acute myocarditis.) since 2018.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (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 (acute fulminant myocarditis) (seriousness criteria hospitalization, medically significant and life threatening). an unknown date, the patient experienced MALAISE (generalised malaise) and HEADACHE (headache). an unknown date, the patient experienced HYPERHIDROSIS (diaphoresis) and CHILLS (chills). an unknown date, the patient experienced FATIGUE (Fatigue) and PYREXIA (Fevers). The patient was treated with IBUPROFEN for Fatigue, Fever and Diaphoresis, at a dose of UNK dosage form; ACETAMINOPHEN for Fatigue, Fever and Diaphoresis, at a dose of UNK dosage form; METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) (intravenous) for Myocarditis, at a dose of 1000 mg once a day; METHYLPREDNISOLONE for Myocarditis, at an unspecified dose and frequency and TEMOZOLOMIDE (TEMODAR) from 2018 to 2020 for Acute myocarditis, at an unspecified dose and frequency. At the time of the report, CARDIOGENIC SHOCK (Cardiogenic shock), MYOCARDITIS (acute fulminant myocarditis), MALAISE (generalised malaise), HYPERHIDROSIS (diaphoresis), FATIGUE (Fatigue), PYREXIA (Fevers), HEADACHE (headache) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Adenovirus test: negative Negative. On an unknown date, Angiocardiogram: No epicardial coronary disease. On an unknown date, Biopsy heart: Focal lymphocytic interstitial in filtrate with myocyte damage consistent with lymphocytic myocarditis. The vast majority of the lymphocytic infiltrates consisted of CD3 and CD68 cells, with a small proportion of CD20 cells. C4d staining was negative.. On an unknown date, Blood creatinine: no creatinine elevation. On an unknown date, Blood lactate dehydrogenase: Maximum Lactate dehydrogenase of 494 and 434 iu/l. On an unknown date, Blood pressure measurement: 99/78 mm hg (Mean Arterial Pressure of 85 mm Hg). On an unknown date, Body temperature: 38.9 degrees celcius and 37.8°c. On an unknown date, Brain natriuretic peptide: 1636 pg/ml. On an unknown date, C-reactive protein: 236.07 mg/l. On an unknown date, Cytomegalovirus test: positive (Positive) CMV IgG- positive, CMV IgM- negative and negative Immunohistochemistry for cytomegalovirus was performed and was negative. On an unknown date, Echocardiogram: Did not show any apical ballooning, making the diagnosis of Takotsubo cardiomyopathy less likely. and lvef of 10%. On an unknown date, Ejection fraction: 10% 10% and Right ventricular ejection fraction was normal at 47%.. On an unknown date, Electrocardiogram: Sinus tachycardia with a right bundle branch block. On an unknown date, Fibrin D dimer: 384 ng/ml. On an unknown date, Haemodynamic test: found the following: CVP of 4, pulmonary artery systolic of 18, pulmonary artery diastolic of 10 and a PCWP of 5 with an accompanying cardiac index of 3.03.. On an unknown date, Haemoglobin: 102 g/l. On an unknown date, Heart rate: 133 beats per minute. On an unknown date, Herpes simplex test: negative (Negative) herpes simplex virus (HSV) 1 and 2 Negative and negative Negative. On an unknown date, Magnetic resonance imaging heart: Left ventricular dysfunction with global hypokinesis and LVEF of 27% and areas of septal late gadolinium enhancement (LGE) in a non- coronary vascular distribution. On an unknown date, Neurological examination: significant only for left- sided Significant only for Left- sided visual field loss, which was known and stable since his GBM diagnosis and treatment.. On an unknown date, Oxygen saturation: 90% 90% on 5 L oxygen administered via nasal cannula.. On an unknown date, Red blood cell sedimentation rate: 78 mm. On an unknown date, Respiratory rate: 33 breaths per minute. On an unknown date, SARS-CoV-2 antibody test: negative Negative. On an unknown date, SARS-CoV-2 test: negative Negative. On an unknown date, Serum ferritin: 1245 ng/ml. On an unknown date, Toxoplasma serology: negative (Negative) IgM Toxoplasma neg. On an unknown date, Troponin I: 8.3 mg/ml.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered CARDIOGENIC SHOCK (Cardiogenic shock), MYOCARDITIS (acute fulminant myocarditis), FATIGUE (Fatigue) and PYREXIA (Fevers) to be related and MALAISE (generalised malaise), HYPERHIDROSIS (diaphoresis), HEADACHE (headache) and CHILLS (chills) to be possibly related.    Pulmonary artery catheterisation using central venous pressure (CVP), pulmonary artery pressure, pulmonary capillary wedge pressure (PCWP) and mixed venous cardiac output (Mixed venous oxygen saturation) calculations were used to guide therapy.  Company comment: This literature non-study case concerns a 38-year-old male patient with no relevant medical history, who experienced the unexpected life-threatening (hospitalization, medically significant) events of Myocarditis and Cardiogenic shock after the first dose of mRNA- 1273 Moderna vaccine. The onset of the events occurred approximately 8 days after vaccination. Initial clinical manifestations included pyrexia, pleuritic chest pain and dyspnoea. Subsequently, hypotension and cardiogenic shock developed. Circulatory support with an axial flow catheter pump was required. Laboratory results showed C-reactive protein of 236.07 mg/l (range not provided), Troponin of 8.3 mg/mL (range not provided) and Brain natriuretic peptide of 1636 pg./ml (range not provided).  Electrocardiogram showed sinus tachycardia with a right bundle branch block. Echocardiogram showed new LVEF of 10% with apical akinesis and hypokinesis at the mid and basal left ventricle, without apical ballooning. Coronary angiogram was normal. Endomyocardial biopsy  was performed and consistent with lymphocytic myocarditis. Pulse dose steroids were given for 3 days, leading to haemodynamic recovery. Infectious and inflammatory aetiology was ruled out. IHQ for CMV, HSV 1 and 2, VZV and adenovirus was negative. Treponemal antibody and additional serologies were also negative. At the time of the report, the event had resolved and patient had been discharged. Myocarditis is consistent with the known safety profile of the vaccine, but since is was a life-threatening event associated with cardiogenic shock it is considered unexpected. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 09-Dec-2021: Follow up received by safety on 09-Dec-2021 has Email contains significant information (Author name, Lab data, Medical history, Event, Drug information); Sender's Comments: This literature non-study case concerns a 38-year-old male patient with no relevant medical history, who experienced the unexpected life-threatening (hospitalization, medically significant) events of Myocarditis and Cardiogenic shock after the first dose of mRNA- 1273 Moderna vaccine. The onset of the events occurred approximately 8 days after vaccination. Initial clinical manifestations included pyrexia, pleuritic chest pain and dyspnoea. Subsequently, hypotension and cardiogenic shock developed. Circulatory support with an axial flow catheter pump was required. Laboratory results showed C-reactive protein of 236.07 mg/l (range not provided), Troponin of 8.3 mg/mL (range not provided) and Brain natriuretic peptide of 1636 pg./ml (range not provided).  Electrocardiogram showed sinus tachycardia with a right bundle branch block. Echocardiogram showed new LVEF of 10% with apical akinesis and hypokinesis at the mid and basal left ventricle, without apical ballooning. Coronary angiogram was normal. Endomyocardial biopsy  was performed and consistent with lymphocytic myocarditis. Pulse dose steroids were given for 3 days, leading to haemodynamic recovery. Infectious and inflammatory aetiology was ruled out. IHQ for CMV, HSV 1 and 2, VZV and adenovirus was negative. Treponemal antibody and additional serologies were also negative. At the time of the report, the events had resolved and patient had been discharged. Myocarditis is consistent with the known safety profile of the vaccine, but since it was a life-threatening event associated with cardiogenic shock it is considered unexpected. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report