Received Oct 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK356AA | OT |
administered the [HIB] powder did not realize that it was supposed to be two components with no adverse event; Initial information received on 21-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who was administered only the hib powder did not realize that it was supposed to be two components with no adverse event after receiving DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in OCT-2025, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE Suspension for injection (lot UK356AA, expiry: 28-Feb-2027, with unknown strength and dose) via unknown route in unknown administration site as immunization, in which only the HIB powder was administered and medical assistant did not realize that it was supposed to be two components with no adverse event (single component of a two-component product administered) (latency: same day). It was reported, "Clinical coordinator initially reported that they had a child who received the powder component of PENTACEL with sterile water instead of the HIB diluent. Clinical coordinator asked if the DTaP-IPV component is valid and the child only needs to receive the HIB component, or do they need to be revaccinated with the full PENTACEL. Clinical coordinator then clarified that the DTaP-IPV was not administered at all. Apparently only one vial was in the box and the new medical assistant, who administered the HIB powder, did not realize that it was supposed to be two components. The "diluent vial" was unaccounted for, and the patient was not administered with the DTaP-IPV at all. Clinical coordinator added that this event happened last week but cannot provide the exact date." 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.