Received Oct 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
Embolism; Felt weird; felt very tired/ could not step up and could not stand; This spontaneous case was reported by a consumer and describes the occurrence of EMBOLISM (Embolism) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) 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 dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced EMBOLISM (Embolism) (seriousness criterion medically significant), FEELING ABNORMAL (Felt weird) and FATIGUE (felt very tired/ could not step up and could not stand). At the time of the report, EMBOLISM (Embolism), FEELING ABNORMAL (Felt weird) and FATIGUE (felt very tired/ could not step up and could not stand) outcome was unknown. No concomitant medication was reported. It was reported that patient had the same side effects as with the reporter. No treatment information was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-790018 (E2B Linked Report).; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-790018:Reporter case