Received May 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | 4 | 2CA77C1 | OT / LA |
expired daptacel was administered to a patient with no reported adverse event; Initial information received on 01-May-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 21 months old female patient who was administered with an expired diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 01-May-2025, the patient received 0.5 ml of dose 4 of an expired diphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection (strength- standard, expiry date- 30-Apr-2025 and lot 2CA77C1) via intramuscular route in the left deltoid for Immunization with no reported adverse event (expired product administered) (latency- same day). 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.