Received Dec 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
Flu like symptoms; Fever; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (Fever) and HEADACHE (Headaches) in a 77-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. No Medical History information was reported. On 31-May-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In 2025, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (Fever) and HEADACHE (Headaches). In 2025, INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (Fever) and HEADACHE (Headaches) had resolved. Concomitant medication use information was not provided by reporter. The patient had always taken Moderna COVID vaccines and would sometimes experience fever, flu-like symptoms, and headaches after taking Spikevax. The symptoms were typically mild and would appear within 24 hours after the vaccine and would last anytime between a day to a week. It was unknown if the patient experienced any additional symptoms/events. Treatment medication use information was not provided by reporter. This case was linked to MOD-2025-792408 (Patient Link).