Received Oct 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
make her quite sick each time; aches; fever; extreme exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (make her quite sick each time), PAIN (aches), PYREXIA (fever) and FATIGUE (extreme exhaustion) in an elderly female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Co-suspect product included non-company product Evolocumab (Repatha) injection for an unknown indication. On 31-Mar-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form and Evolocumab (Repatha) (unknown route) at an unspecified dose. In 2025, the patient experienced MALAISE (make her quite sick each time), PAIN (aches), PYREXIA (fever) and FATIGUE (extreme exhaustion). At the time of the report, MALAISE (make her quite sick each time), PAIN (aches), PYREXIA (fever) and FATIGUE (extreme exhaustion) outcome was unknown. Patient had no relevant medical conditions. No concomitant medication was reported. The patient was a senior over 65 and had always got the Moderna COVID vaccines and not the Pfizer. It usually made her quite sick each time (she had a vaccine) but she realized it was an unnecessary evil. She did not want COVID. The symptoms she normally experienced were fever, aches and extreme exhaustion. This happened after each COVID vaccine, and she had probably had at least 6 of them. She took Repatha (also an injection) and she would be taking it in the same morning, she would be getting the COVID vaccine. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter causality was not provided. This case was linked to MOD-2025-789921 (Patient Link). Reporter did not allow further contact
Repatha