Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | UNK | — | OT |
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | — | OT |
4yr old patient was given adacel instead of daptacel with no reported adverse event; Initial information received on 28-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 4 years old male patient was given Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] instead of Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) ,concomitant medications and family history were not provided. On an unknown date, 4 year old patient was given adacel (Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine ) instead of daptacel (Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine ) with no reported adverse event (wrong product administered) (Suspension for injection) strength, expiry date, lot number not reported via unknown route in unknown administration site for Immunization (latency: same day). The information on batch number and expiration date corresponding to the one at time of event occurrence was requested. Reportedly "This was to be his fifth dose on Daptacel schedule. " 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.