Received Nov 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 4 | — | — |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (flu) in a 64-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine for an unknown indication. Previously administered products included for COVID-19 prophylaxis: moderna covid-19 vaccine (dose 1) in February 2021 and moderna covid-19 vaccine (dose 2) in March 2021. Past adverse reactions to the above products included Flu with moderna covid-19 vaccine and moderna covid-19 vaccine. In 2024, the patient received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. In 2024, the patient received dose of Influenza vaccine (unknown route) 1 dosage form. On an unknown date, the patient received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (flu). At the time of the report, INFLUENZA (flu) had resolved. No concomitant medication was reported. Patient had 4 vaccines since they started. She received 4 doses in total. Her last vaccine was administered approximately 1 year ago. Every single vaccine she received was a Moderna product. Patient had the vaccine several times and after 24 hours she had major side effects. She felt like she had the flu for 24 hours. She gets severe body aches and a headache. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. This case was linked to MOD-2025-791112 (Patient Link).