Received Oct 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | UT8409CA | — |
Developed a severe case or rash; Developed a severe case or rash and hives which lasted for more than 4 months; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Developed a severe case or rash) and URTICARIA (Developed a severe case or rash and hives which lasted for more than 4 months) in a 69-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 immunization. Co-suspect product included non-company product Influenza vaccine inact split 3v (Fluzone high dose) for Influenza immunization. Previously administered products included for Prophylactic vaccination: Fluzone HD in 2020, Fluzone HD in 2021 and Fluzone HD in 2023; for COVID-19 immunization: Moderna COVID-19 Vaccine. Past adverse reactions to the above products included No adverse effect with Fluzone HD, Fluzone HD, Fluzone HD and Moderna COVID-19 Vaccine. In 2024, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of Influenza vaccine inact split 3v (Fluzone high dose) (unknown route) 1 dosage form. In 2024, the patient experienced RASH (Developed a severe case or rash) and URTICARIA (Developed a severe case or rash and hives which lasted for more than 4 months). At the time of the report, RASH (Developed a severe case or rash) and URTICARIA (Developed a severe case or rash and hives which lasted for more than 4 months) had resolved. Concomitant medication use information was not provided by reporter. In 2024, the patient received FLUZONE HD (high dose) (Influenza USP trivalent A-B high dose subvirion vaccine suspension for injection in a pre-filled syringe) and Moderna COVID vaccines but developed a severe case of rash and hives which lasted for more than 4 months. The reporter wanted to know if the patient would still receive FLUZONE HD this year. The reporter was not sure if it was really caused by FLUZONE HD because the patient also received the Moderna COVID vaccine, which they had been able to use before. The reporter wanted to know if the ingredients of FLUZONE HD this year had changed from the last year. It was not reported if the patient received corrective treatment for the events.