Received Jan 1, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | U8507CA | OT / RA |
administration of an expired vaccine fluzone hd with no reported adverse event; Initial information along with live follow up received on 29-Dec-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 87 years old female patient who had administration of an expired influenza usp trival a-b high dose subvirion vaccine [fluzone hd] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 17-Oct-2025, the patient received expired 0.5 ml dose of suspect influenza usp trival a-b high dose subvirion vaccine Suspension for injection in pre-filled syringe (lot U8507CA, Expiry date: 30-Jun-2025, strength: high) via intramuscular route in the right deltoid for influenza 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.