Received Jan 6, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | UT8415NA | OT / RA |
expired FLUZONE NP was administered to a patient with no reported adverse event; Initial information received on 30-Dec-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 68 years old male patient who was administered with expired 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 18-Dec-2025, the patient received 0.5 ml dose of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine, Suspension for injection, lot UT8415NA, expiry date:30-Jun-2025, strength: standard, Frequency = once via intramuscular route in the right deltoid for Influenza with no reported adverse event (expired product administered) (latency: same day). It was reported "reporter clarified that it's just the regular dose that was given to an elderly patient. LVN spoke to the patient on 22-Dec-2025 and he had nothing at that time. He talked to the patient again this morning before he made this call and it was reported that the patient had no reaction or symptoms". 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.