Received Jul 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 4 | UK233AC | OT / RL |
inappropriate use due to extra dose of Hib administered with no reported adverse event; Initial information received on 17-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old female patient who was administered to extra dose of Haemophilus Type B (Hib) 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 Haemophilus Type B (Hib) Vaccine (ACT-HIB) for Immunisation. On 15-Jul-2025, the patient received 0.5mL (dose 4) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection (lot UK233AC, expiry date 31-Aug-2026, strength standard, frequency once) via intramuscular route in the right thigh for Immunisation and inappropriate use due to extra dose of hib administered with no reported adverse event (extra dose administered) (latency same day). Reportedly, ACTHIB and Pentacel were administered on the same day. She wanted to knowany safety information in relation to this incident. 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.
ACTHIB