Received Aug 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 4 | UK330AA | OT |
inadvertently administered pentacel powder reconstituted with sterile water only with no reported adverse event; Initial information received on 05-Aug-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 2 years old and unknown gender patient who was inadvertently administered Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] powder reconstituted with sterile water only 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, the patient received dose 4 of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine(strength, dose unknown) Powder and suspension for suspension for injection lot UK330AA expiry date-31-Jul-2026 via unknown route in unknown administration site for Immunization, inadvertently administered pentacel powder reconstituted with sterile water only with no reported adverse event (product preparation error) (same day latency). 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.