Received May 30, 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 to two patients. liquid dtap/ipv portion not administered with no reported ae; nurse reconstituted the hib powder portion of pentacel with an unknown liquid to two patients. liquid dtap/ipv portion not administered with no reported ae; Initial information received on 20-May-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (non-healthcare professional). This case was linked with US-SA-2025SA154169. This case involves a 15 months old patient with unknown gender for 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/ipv portion not administered with no reported adverse event. Reportedly, there was no parental drug exposure. The patient have unknown medical history/condition, concomitant disease and risk factor or lab tests. Reporter reported that the suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection (lot number, expiry date and strength not reported) for Immunization for patient 15 months old (Immunisation) and nurse reconstituted the hib powder portion of pentacel with an unknown liquid to two patients. liquid dtap/ipv portion not administered with no reported adverse event (single component of a two-component product administered), (product preparation error) (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-2025SA154169: