Received Sep 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | IM |
flu like symptoms/flu like symptoms, aches, headache A little better but still achy; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms/flu like symptoms, aches, headache A little better but still achy) in a 68-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. Co-suspect product included non-company product Influenza vaccine (Flu) for an unknown indication. The patient's past medical history included COVID-19 (Patient was diagnosed with Covid 19.) on 28-Oct-2024. Concomitant products included Etodolac (Lodine) for an unknown indication. On 12-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. On 12-Sep-2025, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms/flu like symptoms, aches, headache A little better but still achy). On 14-Sep-2025, INFLUENZA LIKE ILLNESS (flu like symptoms/flu like symptoms, aches, headache A little better but still achy) had resolved. The action taken with mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) was unknown. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use), the reporter did not provide any causality assessments. The patient had no medical history, concomitant disease or risk factor. There were no lab data or results available. It was reported that within the first 24 hours after vaccination the patient had experienced flu-like symptoms, aches, headache. These symptoms were a little better but still achy until 48 hours. It was unknown if the patient experienced any additional symptoms or events. Treatment medication was not reported.
Medical History/Concurrent Conditions: COVID-19 (Patient was diagnosed with Covid 19.)
Lodine