Received Oct 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 1 | UK113AB | OT / RL |
inadvertently administering expired dose of act-hib to a patient with no reported adverse event; Initial information received on 06-Oct-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 2 months old female patient who inadvertently administering 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. On 01-Oct-2025, the patient inadvertently received expired dose 1 of 0.5 ml dose of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection (lot UK113AB, expiry date: 30-Sep-2025, Strength: standard, Indications: Immunization) via intramuscular route in the right thigh (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.