Received Oct 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | U7905AA | OT |
administration of an expired adacel dose, with no reported adverse event; Initial information received on 14-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who had administration of 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 09-Oct-2025, the patient received expired dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection (lot: U7905AA, Expiry date: 03-Oct-2025) (dose, strength, route, administration site was unknown) as immunization (expired product administered; latency: same day). It was reported "They stated that they read the expiration date for ACTHIB as 30Oct2025 instead of 03Oct2025, which they only realized following administration on 09Oct2025." 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.