Received Apr 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | UNK | — | OT |
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | — | OT |
they reconstituted act-hib with Daptacel instead of the provided diluent with no reported adverse event; Initial information received on 15-Apr-2025 (with live follow up received on 15-APR-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 who received HIB (PRP/T) vaccine [ACT-HIB] reconstituted with diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] 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 unknown dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (Unknown strength, lot and expiry date) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) reconstituted with diphtheria-15/tetanus/5 AC pertussis vaccine at the 15-month visit with no reported adverse event (product preparation error) (unknown latency). Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly- Caller mentioned that the DTap was Daptacel and the situation has been a practice for years and there were over 2000 patients administered. 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.