Received Nov 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | UNK | 3CA03C3 | OT / LL |
expired daptacel was administered to patient with no reported adverse event; Initial information received on 06-Nov-2025 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to US-SA-2025SA334072. This case involves a 2-year-old male patient who received 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. Concomitant medications included Polio Vaccine Inact 3v (Vero) [Ipol] for Prophylactic vaccination (Immunisation). On 27-Oct-2025, the patient received an expired dose of 0.5ml of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine Suspension for injection (lot 3CA03C3, standard strength, frequency once and expiry date-30-Sep-2025) via intramuscular route in the left thigh for Immunization (expired product administered) (latency-same day). Reportedly- expired DAPTACEL was given to 2 patients. 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.; Sender's Comments: US-SA-2025SA334072:02715250
IPOL [POLIO VACCINE INACT 3V (VERO)]