Received May 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | — | OT |
supposed to be administered with pentacel but they were only able to inject the liquid part with no reported ae; Initial information received on 09-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 7 months old and unknown gender patient to whom administered with Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)] but they were only able to inject the liquid part 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 received a unknown dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Powder and suspension for suspension for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site as immunization and supposed to be administered with pentacel but they were only able to inject the liquid part with no reported ae (product preparation error) (same day latency). Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested. Reportedly: Caller asked for the diluent to be mix the powder part with and if they can use other Hib vaccines. Action taken: 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.