Received Nov 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK367AA | OT / RL |
Nurse prepared it mixed the ACT-HIB with a sterile diluent used and did not use the DTaP-IPV components with no reported adverse event; Initial information received on 20-Nov-2025 regarding an unsolicited valid non-serious case received from a other health professional which was processed together with live follow-up received on 20-Nov-2025. This case is linked to case US-SA-2025SA350857. This case involves a 15 months old female patient to whom given DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] which was prepared by mixed the act-hib with a sterile diluent and did not use the dtap-ipv components 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 conjugate for Prophylactic Vaccination. On 19-Nov-2025, the patient received 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (Suspension for injection) (lot UK367AA and expiry date: 31-MAR-2027) (strength: standard) (frequency: once) via intramuscular route in the right thigh for Immunization which was prepared by mixed the act-hib with a sterile diluent and did not use the dtap-ipv components with no reported adverse event (product preparation error) (latency: same day). It was reported "the float nurse that prepared it mixed the ACT-HIB with a sterile diluent used, and did not use the DTaP and IPV, as those blue-top vials are still unopened in the box unopened, but the adjacent green-top vial is gone". 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.; Sender's Comments: US-SA-2025SA350857:
Pneumococcal conjugate vaccine