Received Aug 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | UNK | 3CA55C1 | OT |
daptacel inadvertently administered to an 8-year-old patient with no reported adverse event; Initial information received on 08-Aug-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 8 years old and unknown gender patient who was administered inadvertently to 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 04-Aug-2025, the patient received an unknown dose of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection (lot 3CA55C1, expiry date 31-Aug-2026, strength not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation) and inadvertently administered to an 8-year-old patient with no reported adverse event (product administered to patient of inappropriate age) (latency same day). 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.