Received Dec 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK344AA | OT / RL |
stated that the pentacel components were not mixed together, and instead a nurse reconstituted the hib component with sterile water and administered that with no adverse event; Initial information received on 22-Dec-2025 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 3 months old male patient and healthcare professional reported that the Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] components were not mixed together, and instead a nurse reconstituted the hib component with sterile water and administered that, 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 20v (CRM197) (Prevnar 20) and Rotavirus vaccine (Rotavirus vaccine) for Immunisation. On 19-Dec-2025, the patient received 0.5 ml (once) dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Powder and suspension for suspension for injection (strength: not reported) (lot: UK344AA, expiry date: 31-Jan-2027) via intramuscular route in the right vastus lateralis for immunization, and the HCP stated that while administering the pentacel components were not mixed together, and instead a nurse reconstituted the hib component with sterile water and administered that with no adverse event (product preparation error). It was reported, "HCP reported that the Pentacel components were not mixed together as recommended, and instead a nurse reconstituted the Hib component with sterile water and administered that to the patient. The DTaP-IPV component was not administered. It was meant to be the second dose in the series." 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.
Prevnar 20; Rotavirus vaccine