Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Auscultation, Blood alkaline phosphatase, Blood bilirubin
Clinical narrative: MYOCARDITIS; TROPONIN I INCREASED; CATHETERISATION CARDIAC NORMAL; ECHOCARDIOGRAM NORMAL; MAGNETIC RESONANCE IMAGING HEART; This spontaneous report received from a health care professional via media (via a traditional media report article) via Regulatory Authority VAERS (Vaccine Adverse Event Reporting System); concerned a 29-year-old male patient. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies and had no current illness. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, 1 total, administered on 19-MAY-2021 for prophylactic vaccination. Age at time of vaccination 29 years old. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, one week after vaccination the patient presented with acute onset chest pain, shortness of breath, palpitations, and nausea. The patient reported cleaning his pool and inhaling chlorine gas, immediately after which the patient experienced chest tightness. The chest pain was reported as constant, 8/10, midsternal, pleuritic, positional in nature, pressure-like, with radiation to bilateral arms. The pain was exacerbated by lying down and alleviated by sitting up, leaning forward, and Tylenol. The patient was in good health otherwise and denied any illicit substance use prior to arrival. The patient denied any adverse events immediately following vaccination. On physical examination, the patient was found to be afebrile and hemodynamically stable on admission. On physical examination, the patient was alert, oriented to time, place, and person, and not in acute distress. The oral temperature was 97.7 degrees Fahrenheit, blood pressure was 131/84 mm Hg, pulse 68 beats per minute, respiratory rate 19 per minute, and Oxygen saturation SP02 100 percent on room air. The cardiac auscultation revealed a normal S1 and S2 with no extra heart sounds. The remainder of the examination was normal. The possible differential diagnoses were pericarditis and non-ST elevation myocardial infarction (NSTEMI). The patient's Troponin I was elevated at 1.98 ng/ml. A 12-lead EKG revealed normal sinus rhythm with an incomplete right bundle branch block (RBBB). Due to continued troponin elevation (peaking at 15.65 ng/mL) (troponin I increased) and persistent recurrent pleuritic, positional chest pain, the patient was started on a heparin drip and transferred to a different facility for an urgent left heart catheterization to rule out ischemia. The cardiac catheterization revealed angiographically normal coronary arteries. The patient also underwent a transthoracic echocardiogram (TTE), which showed normal left ventricular function with an ejection fraction of 60 percent. No structural, valvular, or wall motion abnormalities were noted. No ultrasonographic evidence of pricardial or pleural effusion was noted. On 25-MAY-2021,the patient experienced myopericarditis with elevated troponin and was hospitalized on an unspecified date. On 25-MAY-2021, Laboratory data included: Catheterisation cardiac (NR: not provided) Normal coronaries, Echocardiogram (NR: not provided) Normal left ventricular function, Magnetic resonance imaging heart (NR: not provided) Not reported, and Troponin I (NR: not provided) 15. Laboratory data (dates unspecified) included: Alanine aminotransferase (NR: 10 - 24) 55 U/L, Alkaline phosphatase (NR: 38 - 126) 68 U/L, Aspartate aminotransferase (NR: 10 - 60) 45 U/L, Auscultation (NR: not provided) normal S1 and S2, blood urea nitrogen (BUN) (NR: 5 - 25) 11 mg/dL, Bilirubin total (NR: 0.2 - 1.3) 1.1 mg/dL, Blood pressure (NR: not provided) 131/84 mmHg, Body temperature (NR: not provided) 97.7 F, C-reactive protein (NR: 0 - 0.74) 0.33 mg/dL, Cardiac MRI (NR: not provided) myocarditis, Cardiac catheterization (NR: not provided) angiographically normal, Creatine kinase (NR: 22 - 232) 3860 IU/L, Electrocardiography (EKG) (NR: not provided) normal sinus rhythm, Ejection fraction (NR: not provided) 60 percent, Erythrocyte sedimentation rate (NR: 0 - 15) 10 mm/h, Hemoglobin (NR: 13.2 - 17.5) 14.4 g/dL, Lipase (NR: 20 - 55) 25 IU/L, Oxygen saturation (NR: not provided) 100 percent, Physical examination (NR: not provided) afebrile, hemodynamically stable, Platelet count (NR: 140 - 450) 251 10^3/uL, Pulse rate (NR: not provided) 68 beats/min, Respiratory rate (NR: not provided) 19 /min, Serum creatinine (NR: 0.61 - 1.24) 1.12 mg/dL, Transthoracic echocardiogram (NR: not provided) normal left ventricular function, Troponin (NR: not provided) peaking at 15.65 ng/mL, Troponin I (NR: not provided) 1.98 ng/mL, Ultrasonography (NR: not provided) no pericardial/pleural effusion, and White blood cell (NR: 4.5 - 11.0) 4.8 10^3/uL. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from troponin I increased, and the outcome of myocarditis, catheterisation cardiac normal, echocardiogram normal and magnetic resonance imaging heart was not reported. This report was serious (Hospitalization Caused / Prolonged).  Additional information was received from company representative via social media (via a traditional media report article) on 12-APR-2022. The following information was updated and incorporated into the case narrative: The symptoms of shortness of breath, palpitations, and nausea subsumed under event of myocarditis, outcome of troponin updated to resolving. Laboratory data added (Alanine aminotransferase, Alkaline phosphatase, Aspartate aminotransferase, Auscultation, BUN, Bilirubin total, Blood pressure, Body temperature, Cardiac MRI, Cardiac catheterization, Hemoglobin, Oxygen saturation, Physical examination, Platelet count, Pulse rate, Respiratory rate, Serum creatinine, Transthoracic echocardiogram, Troponin I, Ultrasonography, WBC, creatinine kinase, C- reactive protein, erythrocyte sedimentation rate, Lipase), treatment medication (Tylenol) and chest pain.; Sender's Comments: V2. This follow up version was created to update following information: The symptoms of shortness of breath, palpitations and nausea subsumed under event of myocarditis, outcome of troponin updated to resolving. Laboratory data added (Alanine aminotransferase, Alkaline phosphatase, Aspartate aminotransferase, Auscultation, BUN, Bilirubin total, Blood pressure, Body temperature, Cardiac MRI, Cardiac catheterization, Hemoglobin, Oxygen saturation, Physical examination, Platelet count, Pulse rate, Respiratory rate, Serum creatinine, Transthoracic echocardiogram, Troponin I, Ultrasonography, WBC, creatinine kinase, C- reactive protein, ESR, Lipase), treatment medication (Tylenol) and chest pain. This updated information doesn't alter previous causality assessment made for the events in this case.  20210624513-COVID-19 VACCINE AD26.COV2.S-MYOCARDITIS,TROPONIN I INCREASED,CATHETERISATION CARDIAC NORMAL,ECHOCARDIOGRAM NORMAL,MAGNETIC RESONANCE IMAGING HEART. This event(s) are considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).