Received May 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK196AA | OT / RL |
inappropriate use due to the administration of the PENTACEL DTaP-IPV component to a patient, without the HIB component with no reported adverse event; Initial information received on 16-May-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 15 months old female patient who was administered with dtap-ipv component of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)], and the Hib component was not included 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 Hepatitis A Vaccine for Immunisation. On 16-May-2025, the patient received 0.5ml (once) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection, Strength standard, lot UK196AA and expiry date 31-Mar-2026 via intramuscular route in the right thigh for immunization, However, only the DTaP-IPV component was administered, and the Hib component was not included with no reported adverse event (single component of a two-component product administered) (Latency Same day). Reportedly, Reportedly, the patient only received the liquid component of Pentacel and did not receive the 'powder' component. The pharmacist inquired whether ACTHIB can be administered to the patient instead of using the Hib component from Pentacel. 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.
HEPATITIS A VACCINE