Received Sep 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | OT |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | UT8409CA | OT |
developed a severe case or rash; developed a severe case or hives which lasted for more than 4 month; Initial information received on 18-Sep-2025 regarding an unsolicited valid non-serious case received from a patient. This case involves 69 years old male patient who developed a severe case or rash and hives which lasted for more than 4 month after receiving Elasomeran (Moderna COVID-19 vaccine) and Influenza USP TRIVAL A-B High Dose Subvirion Vaccine [Fluzone HD]. The patient's past vaccination(s) included Fluzone HD for prophylactic vaccination (immunization) in 2020, 2021, 2023 with no adverse reaction and Moderna Covid Vaccine for COVID-19 immunization. The patient's past medical history, medical treatment(s) and family history were not provided. On an unknown date in 2024, the patient received a dose of suspect Influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (lot UT8409CA) for Influenza (Influenza immunization) and received a dose of suspect Moderna COVID-19 vaccine not produced by Sanofi Pasteur (unknown formulation and lot number) for COVID-19 immunization, both (strength, expiry date -not reported) via unknown route in unknown administration site. On an unknown date in 2024 the patient developed a severe case or rash (rash) and hives which lasted for more than 4 month (urticaria) (unknown latency) following the administration of Influenza USP trival A-B high dose subvirion vaccine and Moderna COVID-19 vaccine. Reportedly, Patient stated that last year, they got FLUZONE HD (high dose) and Moderna Covid Vaccines, but they developed a severe case or rash and hives which lasted for more than 4 month. Patient wanted to know if they can still get FLUZONE HD this year. Patient was not sure if it was really caused by FLUZONE HD because they also got the Moderna Covid Vaccine which they were also able to use before. Patient wanted to know if the ingredients of FLUZONE HD this year changed from last year. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome was Recovered / Resolved on an unknown date for both the events.