Received Jul 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | 5 | 2CA77C1 | OT / LL |
patient was administered with the expired dose of daptacel with no reported ae; Initial information received on 18-Jul-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 5 years old female patient who received an expired dose of 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 14-Jul-2025, the patient received an expired 0.5ml (dose 5) of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine, (once) Suspension for injection, lot 2CA77C1, Strength : Standard and expiry date 30-Apr-2025 via intramuscular route in the left vastus lateralis for Immunization, with no reported adverse event (expired product administered) (Latency Same day). Reportedly, Licensed practical nurse went through their inventory and verified that only 1 patient was administered with the expired dose of Daptacel. Treatment: No, no other immunizations. 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.