Received Mar 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | — | OT |
expired ACTHIB given to a patient, with no reported adverse event; Initial information received on 24-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves patient of an unknown age and gender who was given expired 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 an unknown date in 2025, the patient was given expired HIB (PRP/T) vaccine (Powder and solvent for solution for injection) (expiry date: 31-Dec-2024) (strength unknown) with no reported adverse event (expired product administered) (latency: same day) via unknown route in unknown administration site for Immunisation. 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.