Received Aug 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK196AAN | OT |
only administered the DTAP/POLIO portion and not the HIB component with no reported adverse event; Initial information received on 14-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 months old patient with unknown gender who was only administered to Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel] with the dtap/polio portion and not the hib component 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 Pneumococcal vaccine conj 15v (CRM197) (Vaxneuvance) and rotavirus vaccine for Immunisation. On 14-Aug-2025, the patient received 0.5mL (frequency once) of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection (lot UK196AAN, expiry date 31-MAR-2026, strength not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) and was administered the dtap/polio portion and not the hib component with no reported adverse event (product preparation issue). Reportedly, they wanted to know if they can use a sterile diluent to mix with HIB to give the remainder of that combination vaccine. Concomitnat- rotavax. 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..
Vaxneuvance; ROTAVIRUS VACCINE