Received May 11, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | — | — |
inappropriate use due to hcp not reconstituting product with the correct diluent with no reported adverse event; Initial information received on 24-Apr-2026 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves a patient of unknown age and unknown gender who had inappropriate use of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/5/IPV (VERO)/HIB(PRP/T) VACCINE (PENTACEL) due to healthcare professional (HCP) not reconstituting product with the correct diluent with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s), family history were not provided. On an unknown date, the patient had an inappropriate use of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/5/IPV (VERO)/HIB(PRP/T) VACCINE powder and suspension for suspension for injection (batch/lot number and expiry date: unknown) (strength: unknown) via unknown route in an unknown administration site for immunization (Immunisation) due to healthcare professional (HCP) not reconstituting product with the correct diluent with no reported adverse event (Product preparation issue, latency: same day). 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.
Comments: NONE