Received Oct 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK113AB | OT |
an expired dose of ACTHIB was administered to a patient with no reported adverse event; Initial information received on 15-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] was administered to a patient of unknown demographics with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 06-Oct-2025, the patient received an unknown expired dose of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection of lot UK113AB and expiry date: 30-Sep-2025 (strength; not reported) via unknown route in unknown administration site for Immunization with no reported adverse event (expired product administered) (latency: on 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.