Received Jun 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | UNK | 3CA20C | OT / LA |
administered with DAPTACEL instead of Tdap (ADACEL) with no reported AE; Initial information received on 13-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 11 years old female patient who had administered Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] instead of tdap (adacel) with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 12-Jun-2025, the patient received 0.5 ml dose of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection, lot 3CA20C, Frequency:once, strength: standard, via intramuscular route in the left arm for immunisation instead of tdap (adacel) with no reported adverse event (wrong product administered) (latency: same day). Reportedly, patient was administered with DAPTACEL instead of Tdap (ADACEL). Caller wanted to know if the dose should be repeated. 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.