Received Aug 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TD | TD ADSORBED (TENIVAC) | SANOFI PASTEUR | UNK | — | OT |
patient was incorrectly administered TENIVAC instead of ADACEL with no reported adverse event; Initial information received on 08-Aug-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and unknown gender patient who was administered with incorrect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] Instead Of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient incorrectly received an unknown dose of suspect Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult, Suspension for injection, (lot number, expiry date and strength not reported) via unknown route in unknown administration site for Immunization instead of adacel 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, Manager mentioned that it was their mistake to administer TENIVAC instead of ADACEL. Nurse clarified that the doctor ordered the Tdap (for the Pertussis component) for the patient but instead, the TENIVAC was administered. 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.