Received Feb 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 3 | — | IM |
developed atrial fibrillation/atrial fibrillation worsened; stroke; blood clot was found in her brain; having blood issues after her first vaccine; we lost her; she started retaining water 2 weeks before we lost her; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (we lost her), ATRIAL FIBRILLATION (developed atrial fibrillation/atrial fibrillation worsened), CEREBROVASCULAR ACCIDENT (stroke) and CEREBRAL THROMBOSIS (blood clot was found in her brain) in a 78-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form and third dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form. In August 2022, the patient experienced FLUID RETENTION (she started retaining water 2 weeks before we lost her). On an unknown date, the patient experienced ATRIAL FIBRILLATION (developed atrial fibrillation/atrial fibrillation worsened) (seriousness criterion medically significant), CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant), CEREBRAL THROMBOSIS (blood clot was found in her brain) (seriousness criterion medically significant) and BLOOD DISORDER (having blood issues after her first vaccine). The patient died on 14-Sep-2022. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, ATRIAL FIBRILLATION (developed atrial fibrillation/atrial fibrillation worsened), CEREBROVASCULAR ACCIDENT (stroke), CEREBRAL THROMBOSIS (blood clot was found in her brain), FLUID RETENTION (she started retaining water 2 weeks before we lost her) and BLOOD DISORDER (having blood issues after her first vaccine) outcome was unknown. Concomitant medication was not reported. Patient started having blood issues after her first vaccine. After her second vaccine she developed atrial fibrillation issues and was rushed to the emergency room for a stroke, and a blood clot was found in her brain. After the third vaccine the atrial fibrillation worsened, and she started retaining water 2 weeks before her death. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.; Reported Cause(s) of Death: we lost her