Received Jun 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | — | OT |
Nurse reconstituted the hib powder portion of Pentacel with an unknown liquid. Liquid DTaP/IPVportion not administered with no reported adverse event; Nurse reconstituted the hib powder portion of Pentacel with an unknown liquid. Liquid DTaP/IPVportion not administered with no reported adverse event; Initial information received on 20-May-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (health care professional). This case involves a 15 months old and unknown gender patient to whom nurse reconstituted the hib powder portion of diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine [pentacel (vero)] with an unknown liquid and liquid dtap/ipvportion not administered 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 an unknown dose of hib powder portion of suspect diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (lot number, strength and expiry date not reported) via unknown route in unknown administration site for Immunization for patient 15 months old (Immunisation) as nurse reconstituted with an unknown liquid and liquid dtap/ipvportion not administered with no reported adverse event (product preparation error) (single component of a two-component product administered) (latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence. 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.; Sender's Comments: US-SA-2025SA150688: