Received May 22, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | UNK | 3CA25C1 | IM / RL |
administration of an expired dose of DAPTACEL to a patient with no AE; Initial information received on 11-May-2026 regarding an unsolicited valid non-serious case received from other or unknown healthcare professional (HCP). This case involves a 2-year-old female patient who was administered an expired dose of Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] with no adverse event. The patient's past medical history, past drugs, vaccination(s), family history, and concomitant medications were not provided. On 07-May-2026, the patient received a 0.5 mL dose 4 of Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine, suspension for injection (batch: 3CA25C1, expiry: 30-Apr-2026) (frequency: once and strength: standard) via intramuscular route in right thigh for immunization [Immunisation]. The patient was administered to an expired dose of Daptacel, with no adverse event (Expired product administered, onset date: 07-May-2026 and latency: same day). Action taken: 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.
Comments: NONE