Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin, Ventricular extrasystoles
Clinical narrative: Revaccination with different COVID-19 vaccine; Interchange of vaccine products; syncope/ almost died; myocarditis; pericarditis; pvcs; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (syncope/ almost died), MYOCARDITIS (myocarditis) and PERICARDITIS (pericarditis) in a 56-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 055F22B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (First dose) on 16-Mar-2021, PFIZER BIONTECH COVID-19 VACCINE (Second dose) on 06-Apr-2021, PFIZER BIONTECH COVID-19 VACCINE (Booster dose) on 09-Oct-2021, PFIZER BIONTECH COVID-19 VACCINE (Booster dose) on 05-Apr-2022 and flu shot (on same day) on 04-Oct-2022. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and flu shot.    On 04-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 20-Nov-2022, the patient experienced SYNCOPE (syncope/ almost died) (seriousness criterion medically significant), MYOCARDITIS (myocarditis) (seriousness criterion medically significant), PERICARDITIS (pericarditis) (seriousness criterion medically significant) and VENTRICULAR EXTRASYSTOLES (pvcs). On an unknown date, the patient experienced COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). The patient was treated with METOPROLOL at a dose of pills. At the time of the report, SYNCOPE (syncope/ almost died), MYOCARDITIS (myocarditis), PERICARDITIS (pericarditis) and VENTRICULAR EXTRASYSTOLES (pvcs) had not resolved and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Nov-2022, Blood pressure measurement: high. On 20-Nov-2022, Troponin: elevated. On an unknown date, Angiogram: Inconclusive. On an unknown date, Coronavirus test: Negative. On an unknown date, Echocardiogram: Inconclusive. On an unknown date, Magnetic resonance imaging: Inconclusive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided.  It was reported that patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that the patient been to the ER 4 times and tested negative for COVID all along. That was seems to be caused by the vaccine. Patient took the last bivalent booster on 5 Oct 2022 and started having issues on 20 Nov 2022. Patient  troponin level was elevated and had chest pains. They did MRI and angiogram, echocardiogram and put on medications. Patient was still not out of the woods although was better. Patient states almost died and had syncope. Patient had shortness of breath, high blood pressure and chest pain. Patient used to swim an hour every day prior to that. Now patient cant even wear a mask because cant breathe. Patient was still struggling with health issues and was diagnosed with PVCs. Myocarditis and pericarditis seem to be the cause of the PVCs. Patient would do another echocardiogram and wear a cardiac monitor in two months. Symptoms were started after bivalent booster and were improved, but not resolved. With no cause determined. Patient did not experienced symptoms like this before receiving the Moderna COVID-19 vaccine.  Company comment: This spontaneous case concerns a 56-year-old male patient with no relevant medical history, who experienced the unexpected serious (medically significant) event of Syncope (listed in Factsheet), expected serious (medically significant) AESIs of Myocarditis and Pericarditis and unexpected non-serious AESI of Ventricular extrasystoles which occurred about 1 month 16 days after the fifth dose of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine in covid-19 vaccination series. After the booster dose, patient had chest pain with elevated troponin levels. MRI, angiogram, and echocardiogram was performed, results are not available, and he was put on medications. Patient states he almost died and had syncope. Patient had shortness of breath, high blood pressure and chest pain. Patient was still struggling with health issues and was diagnosed with PVCs. Myocarditis and pericarditis seem to be the cause of the PVCs. Patient would do another echocardiogram and wear a cardiac monitor in two months. Revaccination with different COVID-19 vaccine and Interchange of vaccine products is noted in this case as the patient received four doses with Pfizer prior to the current vaccination with mRNA-1273.222 (Original/Omicron BA.4/5). The outcome of the events reported as not resolved. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 56-year-old male patient with no relevant medical history, who experienced the unexpected serious (medically significant) event of Syncope (listed in Factsheet), expected serious (medically significant) AESIs of Myocarditis and Pericarditis and unexpected non-serious AESI of Ventricular extrasystoles which occurred about 1 month 16 days after the fifth dose of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine in covid-19 vaccination series. After the booster dose, patient had chest pain with elevated troponin levels. MRI, angiogram, and echocardiogram was performed, results are not available, and he was put on medications. Patient states he almost died and had syncope. Patient had shortness of breath, high blood pressure and chest pain. Patient was still struggling with health issues and was diagnosed with PVCs. Myocarditis and pericarditis seem to be the cause of the PVCs. Patient would do another echocardiogram and wear a cardiac monitor in two months. Revaccination with different COVID-19 vaccine and Interchange of vaccine products is noted in this case as the patient received four doses with Pfizer prior to the current vaccination with mRNA-1273.222 (Original/Omicron BA.4/5). The outcome of the events reported as not resolved. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) Vaccine is not affected by this report.