Received Oct 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | 2 | UT8794CA | OT / LA |
received two doses of the vaccine FLUZONE HD with no reported adverse event; Initial information received on 26-Sep-2025 (with live follow up process together with CSD: 26-Sep-2025) regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 71 years old female patient who received two doses of the vaccine 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 13-Sep-2025, the patient received a dose 1 (0.5ml twice) of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine; Suspension for injection in pre-filled syringe, (lot UT8794CA with expiry date 30-JUN-2026). On 20-Sep-2025 she also received a dose 2 (0.5ml twice) of vaccine with an unknown batch number and expiry date both via intramuscular route in the left arm for Influenza with no reported adverse event (extra dose administered) (latency: 7 days) 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.