Received Jul 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK3066AA | OT |
administration of expired dose of ACT-HIB with no reported adverse event; Initial information received on 14-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 6 months old and unknown gender patient who was administered expired dose of HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 14-Jul-2025, the patient received an unknown dose of expired suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (lot UK3066AA and expiry date 30-Jun-2025) (strength not reported) via unknown route in unknown administration site for Immunization with no reported adverse event (expired product administered) (Latency: same day). Reportedly, There was no extended stability data on Act Hib after expiration. 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.