Received Nov 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | 8080473 | IM |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | UT8409CA | — |
covid-19; urticaria; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of COVID-19 (covid-19) and URTICARIA (urticaria) in a patient of an unknown age and gender who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 8080473) for COVID-19. The suspect product included Pre-filled Syringe injection (batch no. 8080473) for COVID-19 and non-company product included Influenza vaccine (Fluzone) for an unknown indication. No Medical History information was reported. On 12-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter and dose of Influenza vaccine (Fluzone) (unknown route) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. In 2024, the patient experienced COVID-19 (covid-19) and URTICARIA (urticaria). At the time of the report, COVID-19 (covid-19) outcome was unknown and URTICARIA (urticaria) had resolved. No concomitant medications were provided. The patient's past medical history, medical treatments, vaccinations and family history were not provided. In 2024, the patient developed COVID-19 and urticaria approximately few months following the Spikevax and Fluzone (Influenza Quadrival A-B Multidose Vaccine Preserved). Expiry date was not reported for both suspect products. It was not reported if the patient received corrective treatment for both the events.