Received Jul 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | UNK | — | OT |
Accidental administration of DTaP instead of Tdap with no reported adverse event; Initial information received on 22-Jul-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 13 years old male patient who accidentally received Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] instead of Diphtheria, Tetanus And Acellular Pertussis Vaccine 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 in July 2025, the patient received an unknown dose of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection, (unknown strength and expiry date) lot number not reported via intramuscular route in unknown administration site for Tdap vaccination series (immunisation), instead of Diphtheria, Tetanus And Acellular Pertussis Vaccine, (unknown formulation strength and expiry date) lot number not reported with no reported adverse event (wrong product administered) (unknown latency) (Latency Same day). Information regarding batch number corresponding to the one at time of event occurrence is requested. 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.