Age: 31.0
Sex: M
Vaccine: UNK
Symptoms: Abdominal pain, Bacterial test negative, Biopsy heart abnormal, Blood creatinine increased, Blood culture negative
Clinical narrative: Stroke; Multisystem inflammatory syndrome in adults; Cardiogenic shock; Cardiac arrest; SARS-CoV-2; This literature-non-study case was reported in a literature article and describes the occurrence of MULTISYSTEM INFLAMMATORY SYNDROME IN ADULTS (Multisystem inflammatory syndrome in adults), CARDIOGENIC SHOCK (Cardiogenic shock), CARDIAC ARREST (Cardiac arrest), CEREBROVASCULAR ACCIDENT (Stroke) and COVID-19 (SARS-CoV-2) in a 31-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.       No Medical History information was reported.    On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced MULTISYSTEM INFLAMMATORY SYNDROME IN ADULTS (Multisystem inflammatory syndrome in adults) (seriousness criteria hospitalization, medically significant and life threatening). an unknown date, the patient experienced CARDIOGENIC SHOCK (Cardiogenic shock) (seriousness criteria hospitalization, medically significant and life threatening), CARDIAC ARREST (Cardiac arrest) (seriousness criteria hospitalization, medically significant and life threatening), CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant) and COVID-19 (SARS-CoV-2) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 35 days due to CARDIAC ARREST, CARDIOGENIC SHOCK and MULTISYSTEM INFLAMMATORY SYNDROME IN ADULTS. The patient was treated with IMMUNOGLOBULINS NOS (IMMUNOGLOBULIN I.V) (intravenous use) at an unspecified dose and frequency; PREDNISONE at a dose of UNK (Taper); EPINEPHRINE at an unspecified dose and frequency; NOREPINEPHRINE at an unspecified dose and frequency; DOBUTAMINE at an unspecified dose and frequency; METHYLPREDNISOLONE (intravenous use) at a dose of 1 gram once a day; PIPERACILLIN SODIUM, TAZOBACTAM SODIUM (PIPERACILLIN AND TAZOBACTAM) at an unspecified dose and frequency; DOXYCYCLINE at an unspecified dose and frequency and ACYCLOVIR [ACICLOVIR] at an unspecified dose and frequency. At the time of the report, MULTISYSTEM INFLAMMATORY SYNDROME IN ADULTS (Multisystem inflammatory syndrome in adults) had resolved with sequelae and CARDIOGENIC SHOCK (Cardiogenic shock), CARDIAC ARREST (Cardiac arrest), CEREBROVASCULAR ACCIDENT (Stroke) and COVID-19 (SARS-CoV-2) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy heart: SARS-CoV-2 RNA present on cardiac biopsy.. On an unknown date, Blood culture: Both blood cultures and tests for other respiratory viral pathogens were negative.. On an unknown date, Blood pressure measurement: 95/49 mmHg. On an unknown date, Body temperature: 38.6 degree Celsius. On an unknown date, Brain natriuretic peptide: 34.645 picogram per decilitre and (Positive) hospital day 4. On an unknown date, C-reactive protein: 362.7 mg/L. On an unknown date, Ejection fraction: 25 %. On an unknown date, Heart rate: 123 heart beats per minute. On an unknown date, Histology: Histopathology from a myocardial biopsy suggested acute myocarditis.. On an unknown date, Inflammatory marker test: elevated inflammatory biomarkers. On an unknown date, Right ventricular ejection fraction decreased: moderate-severely decreased.. On an unknown date, SARS-CoV-2 antibody test: (Positive) hospital day 5. On an unknown date, Serum ferritin: 8.219 microgram per litre. On an unknown date, Troponin: 4.55 microgram per litre. On an unknown date, White blood cell count: 31.8 10^9/L.     The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.  Company comment: This literature non case concerns a 52-year-old, female patient with no medical history information reported, who experienced the unexpected serious (life threatening, hospitalization and medically significant) AESI of multisystem inflammatory syndrome in adults (MIS-A), cardiogenic shock, cardiac arrest, and serious (hospitalization and medically significant) events of  cerebrovascular accident and COVID 19. The events occurred approximately 6 weeks after first dose of mRNA-1273. As reported, the patient presented with 10-day prodromal illness of fevers, pharyngitis, myalgias and abdominal pain. On presentation, patient's temperature was 38.6°C, heart rate 123bpm, and blood pressure 95/49mmHg. His initial laboratory assessment was notable for WBC 31.8×109/L, CRP  362.7mg/L, ESR 90mm/h, ferritin 8,219µg/L, creatinine 1.63mg/dL, troponin 5,713ng/L (=45ng/L), and NT-pro-BNP of 34,645pg./mL (<125pg./mL). The patient also presented with acute dyspnea in cardiogenic shock complicated by cardiac arrest with an underlying rhythm of ventricular tachycardia on hospital day 2. Following resuscitation, a TTE revealed a LVEF of 25% and global hypokinesis. He required inotropic and vasopressor support with epinephrine, norepinephrine, and dobutamine until hospital day 16. Multiple SARS-CoV-2 PCR tests were performed, only one of which returned positive with a high cycle threshold (34.2). SARS-CoV-2 nucleocapsid IgG antibody was positive. Both blood cultures and tests for other respiratory viral pathogens were negative. An extensive in-hospital workup for infectious (viral and bacterial) and autoimmune myocarditis was unrevealing. During the patient's hospitalization, he met CDC criteria for MIS-A based on his clinical features (severe cardiac illness, hypotension, and vomiting) and laboratory findings (positive SARS-CoV-2 serology, elevated CRP, ESR, ferritin, and procalcitonin). He was treated for presumed MIS-A with 5days of IVIG and 3days of methylprednisolone 1g IV daily, followed by a steroid taper. Patient's LVEF was normalized, patient was discharged after 30 days to acute rehab with residual L sided deficits due to stroke. Considering that patient had concurrent COVID 19 infection which could provide etiology for MIS-A occurring in the patient with described severe consequences causality for the reported events is assessed as not related to mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Concomitant medications were not reported.  The patient presented with 10-day prodromal illness of fevers, pharyngitis, and abdominal pain. The patient also presented with acute dyspnea in cardiogenic shock complicated by cardiac arrest with anunderlying rhythm of ventricular tachycardia on hospital day 2.  Notable cardiac data includes global hypokinesis, mild tricuspid valve insufficiency and no coronary artery disease. The patient treated with pulse dose steroids, antibiotics vasopressors and mechanical ventilation. He did not receive anakinra or any targeted COVID-19 treatment.  Patient's LVEF was normalized, discharged to acute rehab with residual L sided deficits due to stroke.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2023: Significant follow up received on 08-Sep-2023, Report type, reporter's details, literature information, laboratory data, product details, additional event and event details, narrative was updated.