Received Oct 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | — | OT |
received two doses of the HD Flu vaccine, with no reported adverse event; Initial information received on 16-Oct-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves patient of unknown demographics who received two doses of the influenza USP trival A-B high dose subvirion vaccine [Fluzone HD] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 30-Sep-2025, the patient received an unknown dose of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe (strength, dose, expiry date, lot number not reported) via unknown route in unknown administration site for Prophylactic vaccination and he/she also received another dose of vaccine On 15-OCT-2025 with no reported adverse event (extra dose administered) (latency: on same day of last dose). Information regarding batch number corresponding to the one at time of event occurrence is requested. It was reported, she is calling to see if there are any issues or concerns in regard to that happening. It was confirmed with the nurse that the patient received Fluzone HD. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.