Received Mar 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 2 | 1973310 | OT / RL |
administered the act-hib component of pentacel with a sterile water diluent from mmr instead of the dtap-ipv liquid component with no reported adverse event; Initial information received on 13-Mar-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 5 months old female patient who was administered with act-hib component of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine [Pentacel (Vero)] with a sterile water diluent from MMR (measles mumps rubella) instead of the Dtap-IPV liquid component 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 live oral 1v (Rotarix) for Immunisation. On 11-Feb-2025, the patient received 0.5mL (dose 2) of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) vaccine (lot 1973310, expiry date 07-Sep-2026, strength standard and formulation unknown) via intramuscular route in the right thigh for Immunisation and administered with act-hib component of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Vero)/HIB(PRP/T) Vaccine [Pentacel (Vero)] with a sterile water diluent from MMR (measles mumps rubella) instead of the Dtap-IPV liquid component with no reported adverse event (product preparation error). 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; Rotarix