Received Dec 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 1 | UK148AA | OT / LL |
one of the expired doses was also administered to a patient with no reported adverse event; Initial information received on 22-Dec-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 months old female patient reporter reported one of the expired doses was also administered to a patient with no reported adverse event of HIB (PRP/T) VACCINE [ACT-HIB]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 22-Dec-2025, the patient received dose 1 of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection dose 0.5 ml (strength standard) lot UK148AA expiry date- 30-Sep-2025 via intramuscular route in the left thigh for immunization, one of the expired doses was also administered to a patient with no reported adverse event (expired product administered) (latency same day). It was reported "Operations Manager reported that one of their clinics opened a new box of ACTHIB where 2 doses had different lot numbers and were already expired. One of the expired doses was administered to a patient." Action taken- 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.