Received Oct 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK166AB | OT / LL |
ACTHIB expired yesterday, and the vaccine was then administered today with no reported adverse event; Initial information received on 01-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 5 months old female patient who had HIB (PRP/T) Vaccine [ACT-HIB] expired yesterday, and the vaccine was then administered today with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 01-Oct-2025, the patient received a dose (0.5ml) of expired suspect HIB (PRP/T) Vaccine (lot UK166AB with expiry date 30-SEP-2025) (strength and dose not reported) via intramuscular route in the left vastus lateralis for Immunization; yesterday, and the vaccine was then administered today 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.