Received Oct 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK166AB | OT |
Patient was treated with act-hib after it had been expired for 3-days with no reported adverse event; Initial information received on 06-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old male patient was treated with HIB (PRP/T) VACCINE [ACT-HIB] after it had been expired for 3-days with no reported adverse event. The patient's past medical history, medical treatment(s), concomitant(s), vaccination(s) and family history were not provided. On 03-Oct-2025, the patient received 0.5 ml, 1X (once) of suspect HIB (PRP/T) VACCINE, Powder and solvent for solution for injection (lot UK166AB and expiry 30-Sep-2025) after it had been expired for 3-days with no reported adverse event (expired product administered) (latency same day) (strength:-standard) via unknown route in unknown administration site for immunization. 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.