Received Nov 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | — | — |
an expired Fluzone High Dose was administered to a patient with no adverse event; This unsolicited (Non-serious, valid) case belongs to the batch of ICSRs (Individual Case Safety Report) that has been forwarded to the company by the Health Authorities (HA) via Other healthcare professional on 11-Oct-2025 in the format of line listing. This case involves an unknown age/gender patient who received an expired INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 31-Oct-2025, the patient received a expired dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE, Suspension for injection in pre-filled syringe (30-May-2025) with no adverse event (expired product administered) (latency same day) (dose, strength, lot, route and administration site: unknown) for immunization. Information on batch number and expiry date corresponding to the one at time of event occurrence was requested. It was reported that:- The patient is not exhibiting any signs/symptoms of adverse reaction. 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.