Received Aug 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK342AA | OT / LL |
only administered with the dtap-ipv component as it was not reconstituted with the dtap-ipv component with the hib powder component before administration with no reported adverse event; Initial information received on 25-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 months old male patient who was only administered with the dtap-ipv component of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] as it was not reconstituted with the dtap-ipv component with the hib powder component before administration 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 Rotavirus vaccine live reassort oral 5v (Rotateq) and Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for Immunisation. On 21-Aug-2025, the patient received 0.5mL of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine,Powder and suspension for suspension for injection (lot UK342AA, expiry date 31-AUG-2026; strength not reported) via intramuscular route in the left thigh and only administered with the dtap-ipv component as it was not reconstituted with the dtap-ipv component with the hib powder component before administration with no reported adverse event (single component of a two-component product administered) (latency same day). Reportedly, they inquired on behalf of the doctor if Hib portion can be administered alone or should the entire Pentacel dose be repeated. 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.
Rotateq; Prevnar 20