Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, COVID-19 immunisation, Giant cell myocarditis, Immunisation reaction, Interchange of vaccine products
Clinical narrative: Granulomatous myocarditis; Sarcoidosis; Interchange of vaccine products; Revaccination with different COVID-19 vaccine; Syncopal episodes while exercising 6 and 10 weeks after last vaccine dose. Had relatively severe reaction to all three doses; Syncopal episodes while exercising 6 and 10 weeks after last vaccine dose.Had relatively severe reaction to all three doses; This spontaneous case was reported by a consumer and describes the occurrence of GIANT CELL MYOCARDITIS (Granulomatous myocarditis), IMMUNISATION REACTION (Syncopal episodes while exercising 6 and 10 weeks after last vaccine dose. Had relatively severe reaction to all three doses), SYNCOPE (Syncopal episodes while exercising 6 and 10 weeks after last vaccine dose.Had relatively severe reaction to all three doses) and SARCOIDOSIS (Sarcoidosis) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 039K20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    The patient's past medical history included Allergy (( unknown drug)). Concurrent medical conditions included Hypertension and Asthma. Concomitant products included LISINOPRIL, MONTELUKAST, SALBUTAMOL (PROVENTIL [SALBUTAMOL]) and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 19-Jul-2022 at 6:30 PM, the patient experienced IMMUNISATION REACTION (Syncopal episodes while exercising 6 and 10 weeks after last vaccine dose. Had relatively severe reaction to all three doses) (seriousness criterion medically significant) and SYNCOPE (Syncopal episodes while exercising 6 and 10 weeks after last vaccine dose.Had relatively severe reaction to all three doses) (seriousness criterion medically significant). On an unknown date, the patient experienced GIANT CELL MYOCARDITIS (Granulomatous myocarditis) (seriousness criteria death and medically significant), SARCOIDOSIS (Sarcoidosis) (seriousness criterion medically significant), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). The patient died on an unknown date. The reported cause of death was granulomatous myocarditis. An autopsy was performed. At the time of death, IMMUNISATION REACTION (Syncopal episodes while exercising 6 and 10 weeks after last vaccine dose. Had relatively severe reaction to all three doses), SYNCOPE (Syncopal episodes while exercising 6 and 10 weeks after last vaccine dose.Had relatively severe reaction to all three doses), SARCOIDOSIS (Sarcoidosis), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jul-2022, Blood test: (Negative) Negative.         Concomitant medicine also included LISINOPRIL, MONTELUKAST, SALBUTAMOL (PROVENTIL [SALBUTAMOL])  and ZYRTEC for  unknown indications. It was also reported that the patient's cardiologist performed ECG, Cardiac Echo, Cardiac MRI -no results reported. No treatment or further studies were recommended by cardiologist. No treatment was reported. An autopsy was performed. The reported cause of death was sudden adult death due to granulomatous myocarditis. Autopsy also revealed multiple findings in other organs, consistent with sarcoidosis.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a 37-year-old male patient, with medical history of hypertension, asthma and allergy (reported as "relevant past drug history", with unknown drug name) who experienced the unexpected serious fatal, medically significant AESI of giant cell myocarditis. This event was reported as the cause of death, following the autopsy. The patient also experienced the following serious,unexpected, medically significant events: sarcoidosis (also revealed during autopsy as ''multiple findings in other organs, consistent with sarcoidosis''), immunization reaction, and syncope. Giant cell myocarditis and syncope occurred on an unknown date (thus latency between vaccination and these events' onset could not be assessed). Immunization reaction and syncope occurred approximately 19 months from the last (second) dose of mRNA-1273. The patient's previous vaccination included the first dose vaccination with mRNA-1273. The third reported vaccination dose was from another manufacturer- Pfizer TOZINAMERAN vaccine (interchange of vaccine products/ revaccination with different COVID-19 vaccine) Outcome of all events (except the fatal Giant cell myocarditis) was unknown. No treatment was indicated for the events. Reportedly, the patient's cardiologist performed ECG, Cardiac Echo, Cardiac MRI (no results reported), but no treatment or further studies were recommended by cardiologist. Concomitant products included lisinopril, montelukast, salbutamol and Zyrtec, all for unknown indications. It was reported that the patient had relatively severe reaction to all three vaccine doses; however, syncopal episodes while exercising occurred 6 and 10 weeks after last vaccine dose (Pfizer TOZINAMERAN). Concurrent medical conditions of hypertension and asthma, and third vaccination with co-suspect Pfizer TOZINAMERAN remain as significant confounders for all events. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Granulomatous myocarditis.