Received Oct 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 4 | UK113AB | OT / LL |
inadvertently administrating an expired ACTHIB with no reported adverse event; Initial information received on 14-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 12 months old female patient who was inadvertently administered an 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. Concomitant medications included Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) and Measles vaccine, Mumps vaccine, Rubella vaccine (Mmr vaccin) for Immunisation. On 14-Oct-2025, the patient received an expired 0.5mL (dose 4) of suspect HIB (PRP/T) Vaccine, Powder and solvent for solution for injection (lot UK113AB, expiry date 30-Sep-2025, frequency once and strength standard) via intramuscular route in the left thigh for prophylactic vaccination (Immunisation), with no reported adverse event (expired product administered) (latency same day). Reportedly, manager reported that the ACTHIB was expired and given to a patient. How do they proceed from here. 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.