Received Sep 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 1 | UK232AB | OT / LL |
reconstitution of the powder part with sterile water instead of the provided diluent with no reported adverse event; Initial information received on 11-Sep-2025 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 15 months old male patient who received diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (vero)] that was reconstituted with powder part with sterile water instead of the provided diluent 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) for Immunisation. On 08-Sep-2025, the patient received Dose 1 of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Powder and suspension for suspension for injection of standard strength, frequency once with lot UK232AB and expiry date 31-AUG-2026 via intramuscular route in the left thigh for Immunization that was reconstituted with powder part with sterile water instead of the provided diluent with no reported 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.
PREVNAR 20