Received Apr 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 2 | UK010AA | OT / RL |
administration of an expired dose of ACT-HIB, with no reported adverse event; Initial information received on 02-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old female patient who was administration with 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. Concomitant medications included Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Dtap) for Immunisation; and Hepatitis b vaccine (Hepatitis b) for Immunisation. On 01-Apr-2025, the patient received 0.5mL (dose 2) of suspect HIB (PRP/T) Vaccine,Powder and solvent for solution for injection (lot UK010AA, expiry date 28-Feb-2025, frequency once and strength standard) via intramuscular route in the right thigh for Immunisation and administration of an expired dose of act-hib, with no reported adverse event (expired product administered) (latency same day). Reportedly, ACT-HIB was administered to a patient but they did not noticed that the vaccine was expired. They need to see what they need to do on their side. 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.
Dtap; Hepatitis b