Received Jul 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | UNK | — | OT |
| DTAP | DTAP (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
patient had their 5 previous doses, they are good to go. The 5th dose given to the patient was a Tdap, not a DTaP with no reported adverse event; Initial information received on 26-Jun-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 12 years old and unknown gender patient in which 5th dose was given was of Diphtheria, Tetanus And Acellular Pertussis Vaccine [Tdap] 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) and family history were not provided. On an unknown date, the patient received dose of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Tdap] produced by unknown manufacturer, unknown formulation, (lot number, strength and expiry date not reported) via unknown route in unknown administration site for immunization as 5th dose, instead of Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine with no reported adverse event (wrong product administered) (latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly,Nurse mentioned that the medical practice previously administered DTaP to a now 12 year-old patient. They are aware that as long as patient had their 5 previous doses, they are good to go. The 5th dose given to the patient was a Tdap, not a DTaP as patient is already 1. 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.