Received Mar 1, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | UNK | 4CA03C2 | OT |
vaccine administered post excursion with no reported adverse event; Initial information received on 27-Feb-2026 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] administered post excursion 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 an unknown dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE Suspension for injection (lot 4CA03C2 and expiry date-31-Oct-20) via unknown route in unknown administration site for Immunization post excursion with no reported adverse event (poor quality product administered) (latency-same day). It was reported "there was no previous excursion, human error was not involved, extended stability does not cover the data of excursion."? 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.