Received Nov 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | 4 | 3CA03C3 | OT / RL |
inadvertently administered daptacel to patient after the expiration date on the vial with no reported adverse event; Initial information received on 14-Nov-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 years and 11 months old male patient who inadvertently administered expired suspect 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 Hepatitis a vaccine (Hepatitis A) for Immunisation. On 09-Oct-2025, the patient received expired 0.5 ml (dose 4) of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection, lot 3CA03C3, expiry date:30-Sep-2025, strength: standard, Frequency: once via intramuscular route in the right vastus lateralis for Immunization, with no reported adverse event (expired product administered) (latency: same day). It is reported "Clinic manager is asking for guidance after they inadvertently administered DAPTACEL to two patients after the expiration date on the vial". 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.
Hepatitis A