Age: 34.0
Sex: M
Vaccine: COVID19-2, FLU4, FLUC3
Symptoms: Ejection fraction normal, Electrocardiogram T wave inversion, Gastrointestinal disorder, Hypokinesia, Lethargy
Clinical narrative: Myocarditis; Elevated troponin to 1700 / rising troponins (peak level 8359); Inferolateral T wave inversions; Hypokinesis of the basal anterior wall segment; Chest pressure; GI illness; Abdominal pain; Diarrhea; Lethargy; Fevers; Both vaccines were administered on the same day in the same arm; This spontaneous case from was retrieved on 17-Feb-2023 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2574335-1), reported by other healthcare professional and concerned a 34-year-old, male patient.  The patient's concurrent condition included asthma. The patient's concomitant medications were not reported. The patient had no known drug allergy.  On 23-Jan-2023, the patient was vaccinated with non-company, co-suspect Moderna COVID-19 vaccine, Bivalent (elasomeran, imelasomeran; anatomical location: left arm; route of administration: intramuscular; dose and indication: not reported). The batch number reported was 013H22A.  On the same date, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; anatomical location: left arm; route of administration: intramuscular; dose and indication: not reported) (explicitly coded as 'Product administration error'). The batch number reported was 942402. The reported batch number was identified by Seqirus to be linked to suspect product Flucelvax Quadrivalent, instead of reported suspect product Afluria Quadrivalent. Based on the reported batch number, the suspect product was changed to Flucelvax Quadrivalent.  On an unspecified date in Jan-2023, reported as for the next two days after receiving Flucelvax Quadrivalent and non-company, co-suspect Moderna COVID-19 vaccine, Bivalent, the patient subsequently felt relatively usual postvaccination including some fevers and lethargy.  On 26-Jan-2023, Thursday, the patient developed a gastrointestinal (GI) illness with diarrhea and abdominal pain.  On an unspecified date in Jan-2023, the patient recovered from the events of abdominal pain and diarrhea. As reported, two to three days of diarrhea and abdominal pain.  On 29-Jan-2023, the patient presented to the emergency department with chest pressure. The patient was found in his work-up to have elevated troponin to 1700 for which cardiology was consulted. An echocardiogram which showed mild hypokinesis of the basal anterior wall segment but otherwise normal ejection fraction at 56%. The patient was monitored in the hospital and was found to have rising troponins (peak level 8359), electrocardiogram (EKG) was normal on admission however changed to show inferolateral T wave inversions.  On 30-Jan-2023, according to the patient's progression of hospital course, it was decided to take the patient to the Cardiac Cath Lab which showed normal coronaries. According to this finding, the patient's most likely clinical scenario fit with myocarditis post COVID-vaccine and recent GI illness, the patient was started on non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine.  On 31-Jan-2023, the patient was discharged home on colchicine 0.6 mg/day x three months and ibuprofen 600 mg three times daily x four weeks. The patient will follow-up with heart doctor in the next two to three weeks with plan for repeat echocardiogram in three months.  The outcome of the events of gastrointestinal disorder', chest pressure, lethargy, myocarditis, troponin increased', T wave inversion, hypokinesia and fever was not reported.   The reporter did not provide a causality assessment.   All events were considered as serious due to the seriousness criterion of hospitalization. Additionally, the events of 'myocarditis' and 'T wave inversion' were considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  Company comment: A 34-year-old male patient experienced pyrexia and lethargy for the next two days after vaccination with Flucelvax Quadrivalent and non-company, co-suspect Moderna COVID-19 vaccine, Bivalent. Both vaccines were administered in the same arm (explicitly coded as 'Product administration error'). The patient also experienced gastrointestinal illness with abdominal pain and diarrhea. Six days after vaccination the patient was presented to the emergency department with chest pressure and had elevated troponin level. An echocardiogram showed mild hypokinesis of the basal anterior wall segment but otherwise normal ejection fraction at 56%. The patient had rising troponins and electrocardiogram (EKG) was normal on admission however changed to show inferolateral T wave inversions. Reportedly, it was most likely that patient had myocarditis and was started on therapy. Despite confounding with the co-suspect vaccine, causality is assessed as possibly related for events pyrexia, lethargy, gastrointestinal disorder, abdominal pain and diarrhea based on plausible temporal relationship. Even though further clarification is needed for chest pressure, myocarditis, troponin increased, echocardiogram abnormal and electrocardiogram T wave inversion, causality cannot be excluded. Therefore chest pressure, myocarditis, troponin increased, echocardiogram abnormal and electrocardiogram T wave inversion are also assessed as possibly related to the suspect vaccine, based on plausible temporal relationship. Product administration error is assessed as not related to the suspect vaccine, as per the Company specific guidelines.; Sender's Comments: A 34-year-old male patient experienced pyrexia and lethargy for the next two days after vaccination with Flucelvax Quadrivalent and non-company, co-suspect Moderna COVID-19 vaccine, Bivalent. Both vaccines were administered in the same arm (explicitly coded as 'Product administration error'). The patient also experienced gastrointestinal illness with abdominal pain and diarrhea. Six days after vaccination the patient was presented to the emergency department with chest pressure and had elevated troponin level. An echocardiogram showed mild hypokinesis of the basal anterior wall segment but otherwise normal ejection fraction at 56%. The patient had rising troponins and electrocardiogram (EKG) was normal on admission however changed to show inferolateral T wave inversions. Reportedly, it was most likely that patient had myocarditis and was started on therapy. Despite confounding with the co-suspect vaccine, causality is assessed as possibly related for events pyrexia, lethargy, gastrointestinal disorder, abdominal pain and diarrhea based on plausible temporal relationship. Even though further clarification is needed for chest pressure, myocarditis, troponin increased, echocardiogram abnormal and electrocardiogram T wave inversion, causality cannot be excluded. Therefore chest pressure, myocarditis, troponin increased, echocardiogram abnormal and electrocardiogram T wave inversion are also assessed as possibly related to the suspect vaccine, based on plausible temporal relationship. Product administration error is assessed as not related to the suspect vaccine, as per the Company specific guidelines.