Received Mar 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | 939905 | IM |
heart failure; neurological disease; sleep apnea; This spontaneous case was reported by a patient and describes the occurrence of CARDIAC FAILURE (heart failure) in a 65-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 939905) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Sep-2023, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular use) 1 dosage form. On 29-Sep-2021, the patient experienced CARDIAC FAILURE (heart failure) (seriousness criterion medically significant), NERVOUS SYSTEM DISORDER (neurological disease) and SLEEP APNOEA SYNDROME (sleep apnea). At the time of the report, CARDIAC FAILURE (heart failure), NERVOUS SYSTEM DISORDER (neurological disease) and SLEEP APNOEA SYNDROME (sleep apnea) had not resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular use) was unknown. For mRNA-1273 (Spikevax) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant and treatment medication were reported. It was unknown if the patient experienced any additional symptoms/events.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.