Received Nov 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
fatigue; body aches; headaches; chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), MYALGIA (body aches), HEADACHE (headaches) and CHILLS (chills) in a 67-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. The non-company product included Influenza vaccine for an unknown indication. No Medical History information was reported. On 29-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose and dose of Influenza vaccine (unknown route) 1 dosage form. In September 2025, the patient experienced FATIGUE (fatigue), MYALGIA (body aches), HEADACHE (headaches) and CHILLS (chills). In September 2025, FATIGUE (fatigue), MYALGIA (body aches), HEADACHE (headaches) and CHILLS (chills) had resolved. Patient had no vaccines within the past 4 weeks. No concomitant medication was reported. It was reported that 10 to 12 hours after taking the vaccine she experienced severe fatigue, body aches, headaches and chills but no fever. She stated that she had always experienced these symptoms after Spikevax in all 6 previous years. She described them as not debilitating, and that fatigue is the worst of it. She always spaces the Covid vaccine and Flu vaccine to know the side effects are due to which vaccine, and she knows they are due to Spikevax. The symptoms would away after 24 hours. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. This case was linked to MOD-2025-791655 (Patient Link).