Received Oct 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | UT8434KA | OT |
administration of an expired fluzone np with no reported adverse event; Initial information received on 21-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 59 years old male patient who received an expired dose of Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone], with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 21-Oct-2025, the patient received an expired 0.5ml (dose 1) of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine (once), Strength Standard, Suspension for injection, lot UT8434KA and expiry date 30-Jun-2025 via intramuscular route in the deltoid NOS (not otherwise specified) for immunisation, with no reported adverse event (expired product administered) (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.