Received Nov 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | — | OT |
PENTACEL being administered incorrectly described as the liquid portion not being given and the powder portion possibly being mixed with sterile water with no reported adverse event; Initial information received on 18-Nov-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves patient of unknown demographics and is reported diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] being administered incorrectly described as the liquid portion not being given and the powder portion possibly being mixed with sterile water 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 in 2025, suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Powder and suspension for suspension for injection (strength, expiry date, lot number not reported) via unknown route in unknown administration site for immunization being administered incorrectly described as the liquid portion not being given and the powder portion possibly being mixed with sterile water with no reported adverse event (product preparation error) (latency: on same day). It was reported, The caller reported that they have a lone vial of the liquid portion of PENTACEL and a missing powder portion; that they do not know if an error actually occurred; that is is not concrete if anything happened; that they are doing initial fact finding; that there may be a missing vial of the powder portion. Information regarding batch number corresponding to the one at time of event occurrence is requested. 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.