Received Sep 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | — | OT |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | UT8836JA | OT / LA |
stated they mistakenly gave a patient the regular Fluzone instead of the hd with no adverse event; Initial information received on 18-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 67 year old female patient who was they mistakenly given Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] instead of the Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 18-Sep-2025, the patient received an dose of 0.5ml of suspect Influenza USP Trival A-B Subvirion No Preservative Vaccine standard strength frequency once (lot UT8836JA and expiry date-30-Jun-2026) via intramuscular route in the left deltoid for Influenza (Influenza immunisation) instead of Fluzone Hd with no adverse event (wrong product administered) (latency-same day) (latency-same day). 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.