Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation, SARS-CoV-2 test, Troponin, White blood cell count
Clinical narrative: Acute hypoxic respiratory failure; Myocarditis; COVID-19; Coxsackie viral infection; Colitis; This literature-non-study case was reported in a literature article and describes the occurrence of ACUTE RESPIRATORY FAILURE (Acute hypoxic respiratory failure), MYOCARDITIS (Myocarditis), COVID-19 (COVID-19), COXSACKIE VIRAL INFECTION (Coxsackie viral infection) and COLITIS (Colitis) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.   LITERATURE REFERENCE:      The patient's past medical history included COVID-19 (resolved after two-week quarantine).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACUTE RESPIRATORY FAILURE (Acute hypoxic respiratory failure) (seriousness criteria hospitalization and medically significant), MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant), COVID-19 (COVID-19) (seriousness criterion hospitalization), COXSACKIE VIRAL INFECTION (Coxsackie viral infection) (seriousness criterion hospitalization) and COLITIS (Colitis) (seriousness criterion hospitalization). The patient was hospitalized for 10 days due to ACUTE RESPIRATORY FAILURE, COLITIS, COVID-19, COXSACKIE VIRAL INFECTION and MYOCARDITIS. The patient was treated with DEXAMETHASONE at a dose of 6 milligram once a day; REMDESIVIR at an unspecified dose and frequency; VANCOMYCIN for Colitis, at a dose of 1.25 gram every twelve hours; PIPERACILLIN SODIUM, TAZOBACTAM SODIUM (ZOSYN) for Colitis, at a dose of 3.375 milligram once a day; SOTALOL for Atrial fibrillation, at an unspecified dose and frequency; OXYGEN (nasal) at a dose of 2 liter; CIPROFLOXACIN for Colitis, at an unspecified dose and frequency and METRONIDAZOLE (FLAGYL [METRONIDAZOLE]) for Colitis, at an unspecified dose and frequency. At the time of the report, ACUTE RESPIRATORY FAILURE (Acute hypoxic respiratory failure), MYOCARDITIS (Myocarditis), COVID-19 (COVID-19), COXSACKIE VIRAL INFECTION (Coxsackie viral infection) and COLITIS (Colitis) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 89/57 mmHg hypotensive. On an unknown date, Brain natriuretic peptide: 2322 pg/ml. On an unknown date, Chest X-ray: showed no acute cardiopulmonary disease. There was no focal consolidation or congestive heart failure. There was no pleural effusion, cardio-mediastinal silhouette was not enlarged, and trachea was in the midline. There was no pneumothorax. On an unknown date, Computerised tomogram abdomen: Focal fat along the falciform ligament. There was wall thickening of the terminal ileum, cecum, and ascending colon. There was mesenteric stranding and lymphadenopathy noted in the right mesentery. There was no free air, no ascites, and no evidence of gastrointestinal obstruction. (with IV contrast). On an unknown date, Computerised tomogram pelvis: Focal fat along the falciform ligament. There was wall thickening of the terminal ileum, cecum, and ascending colon. There was mesenteric stranding and lymphadenopathy noted in the right mesentery. There was no free air, no ascites, and no evidence of gastrointestinal obstruction. (with IV contrast). On an unknown date, Coxsackie virus test: (Positive) revealed positive high titers of Coxsackie B1-B6 antibodies. On an unknown date, Echocardiogram: decreased left ventricular ejection fraction to 50-55%, mild inferior septal and inferior wall hypokinesis, and a trivial pericardial effusion. On an unknown date, Electrocardiogram: showed sinus tachycardia with a ventricular rate of 142 beats per minute, first-degree atrioventricular block, without any ST-segment changes or other abnormalities. On an unknown date, Heart rate: 130 heart beats per minute tachycardic. On an unknown date, Magnetic resonance imaging heart: revealed diminished biventricular ejection fraction with mild global hypokinesis, lateral apical wall myocardial edema, and epicardial enhancement. Findings were consistent with myocarditis. On an unknown date, Oxygen saturation: 89 % on room air. On an unknown date, SARS-CoV-2 test: (Positive) six weeks prior to presentation and (Positive) on current admission. On an unknown date, Troponin: 864 ng/mL Elevated. On an unknown date, White blood cell count: 15 thousand per cubic millimetre remarkable for leukocytosis.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDITIS (Myocarditis) to be related. No further causality assessments were provided for ACUTE RESPIRATORY FAILURE (Acute hypoxic respiratory failure), COVID-19 (COVID-19), COXSACKIE VIRAL INFECTION (Coxsackie viral infection) and COLITIS (Colitis).    No concomitant medication was reported.  The patient with no significant past medical history presented to the ED with generalized fatigue, nausea, abdominal pain, and diarrhea. The patient obtained the Moderna vaccine after which he developed diarrhea and abdominal pain prompting first visit to the ED. Patient symptoms persisted prompting further evaluation. Patient was afebrile.  The patient was admitted for acute hypoxic respiratory failure secondary to COVID-19 and for management of infectious versus inflammatory colitis. The patient was treated with intravenous hydration.  Due to the patient's echocardiogram findings and elevated brain natriuretic peptide and troponin, myocarditis was on the differential.  It was suggested that either etiology (COVID-19 or Coxsackievirus) could be viable for the given clinical presentation. The patient's hospitalization was also complicated by persistent atrial fibrillation and was unsuccessfully treated with numerous attempts at synchronized cardioversion. Two hours after unsuccessful cardioversions, the patient spontaneously converted to normal sinus rhythm but was maintained on sotalol for three days for rhythm control.  The patient remained hospitalized for a total of 10 days and although hemodynamically stable continued to experience exercise intolerance and fatigue. Patient was medically optimized and discharged home on two more days of dexamethasone, to complete a total 10-day course of steroids.  Author stated patient had multiple etiologies of myocarditis, including the COVID-19 infection, COVID-19 vaccination, and the Coxsackievirus. In viral myocarditis, symptoms develop weeks after the initial viral exposure, which means that any of these etiologies were plausible differentials. Thus, it was difficult to determine the exact cause of myocarditis.  Company comment:This is a literature non-study case concerning a healthy 32-year-old male patient, with no significant past medical history but recently tested positive for COVID-19, who was fully vaccinated with mRNA-1273 vaccine and experienced the expected and serious (hospitalization and medically significant) AESI of MYOCARDITIS, and the unexpected and serious (hospitalization and medically significant) events of ACUTE RESPIRATORY FAILURE (AESI), COVID-19, COXSACKIE VIRAL INFECTION and COLITIS. He tested positive for COVID-19 with anosmia and ageusia, which resolved and three weeks later, he received an unspecified dose of mRNA-1273 vaccine after which he developed diarrhea and abdominal pain. He visited the emergency department and was discharged on ciprofloxacin and metronidazole for colitis; however, his symptoms persisted, and he was admitted for acute hypoxic respiratory failure secondary to COVID-19 and for management of infectious versus inflammatory colitis. He was hypotensive (89/57 mmHg), tachycardic (130 beats per minute), afebrile, and was saturating 89% on room air. Chest x-ray showed no acute cardiopulmonary disease. Laboratories were remarkable for leukocytosis (15 x 103/mm3), elevated high-sensitivity troponin (864 ng/mL), and brain natriuretic peptide (2322 pg/nL). His SARS-CoV-2 PCR test was positive on admission. Electrocardiogram showed sinus tachycardia with a ventricular rate of 142 beats per minute, first-degree atrioventricular block, without any ST-segment changes or other abnormalities. Computerized tomography of the abdomen and pelvis with intravenous contrast showed nonspecific colitis with mesenteric stranding and lymphadenopathy noted in the right mesentery. He was treated with intravenous hydration, supplemental oxygen, dexamethasone 6 milligrams daily, and remdesivir for five days. He was started on vancomycin 1.25 grams every 12 hours and piperacillin-tazobactam 3.375 milligrams daily for the treatment of colitis. He underwent a transthoracic echocardiogram with incidental findings of decreased left ventricular ejection fraction to 50-55%, mild inferior septal and inferior wall hypokinesis, and a trivial pericardial effusion. A cardiac magnetic resonance imaging revealed diminished biventricular ejection fraction with mild global hypokinesis, lateral apical wall myocardial edema, and epicardial enhancement, consistent with myocarditis. Further workup revealed positive high titers of Coxsackie B1-B6 antibodies. His hospitalization was also complicated by persistent atrial fibrillation and was unsuccessfully treated with numerous attempts at synchronized cardioversion. Two hours after unsuccessful cardioversions, the patient spontaneously converted to normal sinus rhythm but was maintained on sotalol for three days for rhythm control. He remained hospitalized for 10 days and although hemodynamically stable continued to experience exercise intolerance and fatigue. He was medically optimized and discharged home on two more days of dexamethasone, to complete a total 10-day course of steroids. Follow up could not be completed since he moved to another location. The numerous overlapping etiologies, which include active COVID-19 infection, recent vaccination series and the Coxsackievirus could be confounders for the event viral myocarditis. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 14-Dec-2022: Live follow up received by safety on 14-Dec-2022 has email with full text article and contains significant information: Reporter details, citation details, medical history, laboratory tests, suspect product, treatment details and event details were updated.; Sender's Comments: This is a literature non-study case concerning a healthy 32-year-old male patient, with no significant past medical history but recently tested positive for COVID-19, who was fully vaccinated with mRNA-1273 vaccine and experienced the expected and serious (hospitalization and medically significant) AESI of MYOCARDITIS, and the unexpected and serious (hospitalization and medically significant) events of ACUTE RESPIRATORY FAILURE (AESI), COVID-19, COXSACKIE VIRAL INFECTION and COLITIS. He tested positive for COVID-19 with anosmia and ageusia, which resolved and three weeks later, he received an unspecified dose of mRNA-1273 vaccine after which he developed diarrhea and abdominal pain. He visited the emergency department and was discharged on ciprofloxacin and metronidazole for colitis; however, his symptoms persisted, and he was admitted for acute hypoxic respiratory failure secondary to COVID-19 and for management of infectious versus inflammatory colitis. He was hypotensive (89/57 mmHg), tachycardic (130 beats per minute), afebrile, and was saturating 89% on room air. Chest x-ray showed no acute cardiopulmonary disease. Laboratories were remarkable for leukocytosis (15 x 103/mm3), elevated high-sensitivity troponin (864 ng/mL), and brain natriuretic peptide (2322 pg/nL). His SARS-CoV-2 PCR test was positive on admission. Electrocardiogram showed sinus tachycardia with a ventricular rate of 142 beats per minute, first-degree atrioventricular block, without any ST-segment changes or other abnormalities. Computerized tomography of the abdomen and pelvis with intravenous contrast showed nonspecific colitis with mesenteric stranding and lymphadenopathy noted in the right mesentery. He was treated with intravenous hydration, supplemental oxygen, dexamethasone 6 milligrams daily, and remdesivir for five days. He was started on vancomycin 1.25 grams every 12 hours and piperacillin-tazobactam 3.375 milligrams daily for the treatment of colitis. He underwent a transthoracic echocardiogram with incidental findings of decreased left ventricular ejection fraction to 50-55%, mild inferior septal and inferior wall hypokinesis, and a trivial pericardial effusion. A cardiac magnetic resonance imaging revealed diminished biventricular ejection fraction with mild global hypokinesis, lateral apical wall myocardial edema, and epicardial enhancement, consistent with myocarditis. Further workup revealed positive high titers of Coxsackie B1-B6 antibodies. His hospitalization was also complicated by persistent atrial fibrillation and was unsuccessfully treated with numerous attempts at synchronized cardioversion. Two hours after unsuccessful cardioversions, the patient spontaneously converted to normal sinus rhythm but was maintained on sotalol for three days for rhythm control. He remained hospitalized for 10 days and although hemodynamically stable continued to experience exercise intolerance and fatigue. He was medically optimized and discharged home on two more days of dexamethasone, to complete a total 10-day course of steroids. Follow up could not be completed since he moved to another location. The numerous overlapping etiologies, which include active COVID-19 infection, recent vaccination series and the Coxsackievirus could be confounders for the event viral myocarditis. The benefit-risk relationship of mRNA-1273 is not affected by this report.