Received Oct 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | — | OT |
gave a pentacel vaccine and didn't use the diluent that came with the box, she used a generic diluent with no reported adverse event; Initial information received on 09-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and gender patient who received diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] and didn't use the diluent that came with the box, used a generic diluent 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 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 for Immunization and didn't use the diluent that came with the box, she used a generic diluent with no reported adverse event (single component of a two-component product administered) (same day latency). Reportedly, any guidance on if the vaccine is viable or if the injection needs to be repeated. 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.