Received Oct 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 4 | UK093AB | OT / LL |
administration of an expired dose of ACTHIB, with no reported adverse event; Initial information received on 08-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old male patient who had administration of an 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. the patient received their previous ACTHIB doses on 13Aug2024 and 02Dec2024 Concomitant medications included Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Daptacel) for Immunisation; and Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for Immunisation. On 06-Oct-2025, the patient received a Dose 4 of expired 0.5 ml dose of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection (lot UK093AB, Expiry date: 30-Sep-2025, strength: standard) via intramuscular route in the left thigh as Immunization with no reported adverse event (expired product administered; latency: 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.
Daptacel; Prevnar 20