Received Feb 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK043AA | OT |
pentacel vaccine was administered without first reconstituting the hib portion of the vaccine with no reported ae; Initial information received on 10-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who received Diphtheria/tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] and that was administered without first reconstituting the HIB portion of the vaccine with no reported AE (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 was administered an unknown dose of suspect Diphtheria/tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (lot UK043AA and expiry date- 31-AUG-2025) (strength - unknown) via unknown route in unknown administration site for immunization, without first reconstituting the HIB portion of the vaccine with no reported AE (single component of a two-component product administered) (latency- same day). Reportedly, HCP (healthcare professional) knows that it counts as a valid DTaP-IPV vaccination, but they would like to administer the HIB portion as well and are requesting 0.4% NaCl solution for dilution of the HIB. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Unknown for the event. 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.