Received Oct 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | UT8437BA | OT / LA |
report that 2 doses of FLUZONE NP from last year were administered to patient with no reported adverse event; Initial information received on 14-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 88 years old female patient who received 2 doses of expired Influenza USP Trival A-B Subvirion No Preservative Vaccine [Fluzone] from last year no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 13-Oct-2025, received expired 2 doses of 0.5ml of suspect Influenza USP Trival A-B Subvirion No Preservative Vaccine from last year Suspension for injection (lot UT8437BA) standard strength, frequency-once and expiry date-30-Jun-2025 via intramuscular route in the left deltoid for Influenza 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.; Sender's Comments: US-SA-2025SA309139: