Received Sep 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | — | OT |
fatigue; Initial information received on 02-Sep-2025 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional. This case involves a 80 years old and unknown gender patient who had fatigue after receiving influenza USP TRIVAL A-B high dose subvirion vaccine [Fluzone High Dose]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in the end of 2024, the patient received an unknown dose of influenza USP TRIVAL A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (strength, expiry date and lot number not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunziation). Information on the batch number could not be requested corresponding to the one at time of event occurrence. On an unknown date the patient had fatigue (unknown latency). Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Unknown for the event.