Received Sep 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | U8527BA | OT / LA |
a patient accidentally received expired Fluzone HD that was from last year with no adverse event; Initial information received on 12-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 71 years old female patient who accidentally received expired Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] that was from last year with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 12-Sep-2025, the patient received expired 0.5mL of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot U8527BA, expiry date 30-Jun-2025, strength high dose) via intramuscular route in the left deltoid for Influenza immunization and accidentally received expired fluzone hd that was from last year with no adverse event (expired product administered) (latency same day). Reportedly, they wanted to know if the patient still needed to get this year's flu shot or not. 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. .