Received Jul 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | — | OT |
dtap-ipv portion of pentacel is used to reconstitute priorix with no reported adverse event; Initial information received on 01-Jul-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age and unknown gender patient who was received with Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] portion of pentacel is used to reconstitute priorix with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine,unknown (lot, expiry date and strength not reported) via unknown route in unknown administration site for Immunization, portion of pentacel is used to reconstitute priorix with no reported adverse event (product preparation error). Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly, Pharmacist confirms that the DTaP-IPV portion of PENTACEL was used to reconstitute Priorix. He explains that he is surprised that this even happened, although PENTACEL and MMR are typically given together, it was still weird that this happened. when the DTaP-IPV portion of PENTACEL is used to reconstitute Priorix; advised that the DTaP-IPV portion of PENTACEL should only be used with the HIB portion of 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.