Received Jun 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | 4 | UK199AA | OT / RL |
instead of the liquid portion of the Pentacel vaccine being administered, the ActHib portion was administered after being reconstituted with sterile water, with no reported adverse event; Initial information received on 10-Jun-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 1 years old female patient who had instead of the liquid portion of the diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (Vero)] being administered, the acthib portion was administered after being reconstituted with sterile water, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 20-May-2025, the patient received liquid portion of a dose 4 (0.25 mL to 2 mL for immunizations or 0.1 mL for TB skin test) of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine (lot UK199AA with unknown strength, formulation and expiry date) via intramuscular route in the right thigh for Immunization; being administered, the acthib portion was administered after being reconstituted with sterile water, with no reported adverse event (single component of a two-component product administered) (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.