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 |
n giving Act Hib reconstituted with Daptacel at the 15-month visit with no reported adverse event; Initial information received on 15-Apr-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and unknown gender patient who received HIB (PRP/T) vaccine [ACT-HIB] reconstituted with diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] at the 15-month visit with no reported adverse event. The patient's past medical history, medical treatment(s), concomitant medication, 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 could not be requested corresponding to the one at time of event occurrence Reportedly, reporter stated that, I have an account that has been giving Act Hib reconstituted with Daptacel at the 15-month visit. The account has not been using the diluent that comes with Act Hib they have been using Daptacel as the diluent. Nurses state that the rep, 15 years ago, informed them that they could use Daptacel to reconstitute Act Hib. 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.