Received Oct 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | U8847BA | OT |
experiencing side effects such as aching; experiencing side effects such as swelling; Initial information received on 02-Oct-2025 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional. This case involves an unknown age female patient who had side effects such as swelling and aching after receiving influenza USP trival A-B high dose subvirion vaccine [Fluzone HD]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 19-Sep-2025, the patient received unknown dose of suspect influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (Unknown strength) with lot U8847BA and expiry date 30-Jun-2026 via unknown route in unknown administration site for Immunization. On an unknown in 2025 the patient developed side effects such as swelling (swelling) and aching (pain) (unknown latency) following the administration of influenza USP trival A-B high dose subvirion vaccine. Action taken was not applicable. It was not reported if the patient received corrective treatment for both the events. At time of reporting, the outcome was Unknown for both the events.