Received Nov 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | UT8804BA | OT / LA |
medication error (unintentional) due to administration of FLUZONE HD that was in transit for more than 48 hours; Initial information received on 20-Nov-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 79 years old female patient who received Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] that was in transit for more than 48 hours. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 20-Nov-2025, the patient received 0.5 ml dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe, lot UT8804BA, strength: standard, frequency: once, via intramuscular route in the left deltoid for Influenza post excursion that was in transit for more than 48 hours (poor quality product administered) (latency: same day). It was reported " Staff pharmacist called to report that they received a shipment of FLUZONE HD this morning and they were told by corporate office that this shipment is not viable because it was in transit for longer than 48 hours. Staff pharmacist mentioned that they need to return the vaccines and added that 1 dose out of the box was used before being notified that the vaccines were not viable". 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.