Received Feb 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | UNK | 2CA28C1 | OT / RA |
the administration of expired daptacel to a patient with no reported adverse event; Initial information received on 10-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age female patient who was administered with expired diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel]with no reported adverse event. List of concomitant vaccines: No other vaccines. On 07-Feb-2025, the patient had administration of expired 0.5mL standard dose of suspect diph-theria-15/tetanus/5 ac pertussis vaccine, Suspension for injection (lot 2CA28C1, expiry date 04-Nov-2024) (Frequency: Once) via intramuscular route in the right arm for Immunization, with no reported adverse event (expired product administered) (latency- same day). Action taken was not applicable. Reportedly, Administrative nursing manager said that the patient was okay and that no adverse events were noted. 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.