Received May 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | 4CA04C1 | OT |
inappropriate use due to possible administration of vaccine post excursion with no reported adverse event; Initial information received on 23-May-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves an unknown age and gender patient who was administered with Diphtheria-2/Tetanus/5 AC pertussis vaccine [Adacel] vaccine 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-2/Tetanus/5 AC pertussis vaccine Suspension for injection (lot 4CA04C1 and expiry date-31-Oct-2026) (strength-unknown) via unknown route in unknown administration site for prophylactic vaccination (Immunisation) post excursion with no reported adverse event (poor quality product administered) (latency-same day). Reportedly- The patient received vaccine that was stored at -0. 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.