Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Bradycardia, COVID-19, Cerebrovascular accident, Tachycardia
Clinical narrative: bradycardia; tachycardia; had too many strokes; COVID-19; This spontaneous case was reported by a patient and describes the occurrence of CEREBROVASCULAR ACCIDENT (had too many strokes) and BRADYCARDIA (bradycardia) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A, 077C21B and 032L20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Aug-2021, the patient experienced COVID-19 (COVID-19). In 2022, the patient experienced CEREBROVASCULAR ACCIDENT (had too many strokes) (seriousness criterion medically significant). On an unknown date, the patient experienced BRADYCARDIA (bradycardia) (seriousness criterion medically significant) and TACHYCARDIA (tachycardia). At the time of the report, CEREBROVASCULAR ACCIDENT (had too many strokes), BRADYCARDIA (bradycardia), TACHYCARDIA (tachycardia) and COVID-19 (COVID-19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered CEREBROVASCULAR ACCIDENT (had too many strokes), BRADYCARDIA (bradycardia) and TACHYCARDIA (tachycardia) to have an unknown relationship. No further causality assessment was provided for COVID-19 (COVID-19).    Concomitant medications were not reported.  The patient had not received any other vaccines in the four weeks prior to COVID-19 vaccine. The patient did not have any previous family history with cardiac symptoms.  It was reported that patient did not recall any immediate adverse events from any of the vaccines; nonetheless, it was unknown if it was related to the vaccines but he had too many strokes since 2022 and was diagnosed with tachycardia and bradycardia approximately 8 months ago. No treatment information was provided by the reporter.  Company comment This spontaneous case concerns an 82-year-old male patient with relevant medical history of COPD, no previous family history with cardiac symptoms, who experienced the unexpected, serious (medically significant) events of Cerebrovascular Accident (AESI) and bradycardia, which occurred on the next year that the third dose of mRNA-1273 was administered. Previously, the patient had received 2 doses of mRNA-1273 within the appropriate schedule of vaccination. It was reported that it was unknown if it was related to the vaccines, but he had too many strokes since 2022 (at least 1 month after the third dose) and was diagnosed with tachycardia and bradycardia approximately 8 months ago. Patient also stated he got COVID-19 about 7 months after the second dose of mRNA-1273. No further clinical information was provided for review. Cerebrovascular accident, bradycardia and tachycardia were assessed as not related to the vaccine due to lack of temporal relationship. The medical history of COPD could be a risk factor for cerebrovascular accident and a confounder for bradycardia and tachycardia. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-752335.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-752335:Wife case