Received Nov 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 1 | UK333AA | OT / LL |
pentacel reconstituted with sterile water instead of the liquid dtap-ipv component with no reported ae; Initial information received on 04-Nov-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old male patient who was reconstituted DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] with sterile water instead of the liquid DTAP-IPV component with no reported ae (adverse event). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 23-Oct-2025, the patient received a dose of 0.5ml (dose 1) of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot UK333AA, standard strength and frequency-once) (expiry date-30-SEP-2026) via intramuscular route in the left thigh for Immunization with sterile water instead of the liquid DTAP-IPV component with no reported ae (adverse event) (product preparation error) (latency- same day). 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.