Received Sep 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | UNK | 4CA03C2 | OT / LA |
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | — | OT |
as an adult patient received DAPTACEL instead of ADACEL with no reported adverse event; as an adult patient received DAPTACEL instead of ADACEL with no reported adverse event; Initial information received on 02-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 21 years old female patient who received diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] instead of diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 02-Sep-2025, the patient received 0.5 ml of diphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection with strength- standard (expiry date- 29-OCT-2026 and lot 4CA03C2) via unknown route in the left deltoid (arm) once for Immunization instead of diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection (strength, expiry date and lot not reported) with no reported adverse event (product administered to patient of inappropriate age) (wrong product administered) (latency- same day). Information on the batch number was requested for Adacel 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.