Received Jun 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | — | OT |
inappropriate use due to administration of adacel post expiry with no reported adverse event; Initial information received on 09-Jun-2025 regarding an unsolicited valid non-serious case received from nurse. This case involves an unknown age and unknown gender patient who had received an expired Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] 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 expired dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection with :expiration date of 05/01 (lot number, and strength not reported) via unknown route in unknown administration site for Immunization with no reported adverse event (expired product administered) (latency:same day). Information on the batch number was requested corresponding to the one at time of event occurrence. 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.