Received May 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | — | OT |
nurse only gave her 1 component and not the other. he thinks that the patient only received the hib component, but he is not sure with no reported ae; Initial information received on 21-May-2025 regarding an unsolicited valid non-serious case received from a consumer/ non-healthcare professional. This case involves a 16 months old female patient and reporter reported that nurse only gave patient 1 component of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] and not the other. Reporter thought that the patient only received the HIB component, but he was not sure 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 in May 2025, the patient received an unknown dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Powder and suspension for suspension for injection with standard strength (expiry date and lot number not reported) once via unknown route in the leg for Immunization and nurse only gave her 1 component and not the other. Reporter thought that the patient only received the HIB component, but he was not sure with no reported adverse event (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.