Received May 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
breathlessness; fatigue; exacerbated a preexisting intermittent ectopic heartbeat; it exacerbated a preexisting intermittent ectopic heartbeat; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (breathlessness) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Ectopic heartbeats (Intermittent ectopic heartbeat). On 10-Apr-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (breathlessness) (seriousness criterion medically significant), FATIGUE (fatigue) (seriousness criterion medically significant), EXTRASYSTOLES (exacerbated a preexisting intermittent ectopic heartbeat) and CONDITION AGGRAVATED (it exacerbated a preexisting intermittent ectopic heartbeat). At the time of the report, DYSPNOEA (breathlessness), FATIGUE (fatigue), EXTRASYSTOLES (exacerbated a preexisting intermittent ectopic heartbeat) and CONDITION AGGRAVATED (it exacerbated a preexisting intermittent ectopic heartbeat) had not resolved. The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown. Concomitant medications were not reported. It was reported that usually the patient had pretty much all the side effects which resolved after a week. It was reported that the patient had exacerbated a pre-existing intermittent ectopic heartbeat. It was unknown if the patient experienced any additional symptoms/events. Treatment information was not reported.; Reporter's Comments: Company comment: The medical history of Intermittent ectopic heartbeat is considered as a confounder. The benefit-risk relationship of product is not affected by this report.
Ectopic heartbeats (Intermittent ectopic heartbeat)