Received Apr 7, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | UNK | 3CA20C1 | IM / LL |
accidentally gave an expired DAPTACEL yesterday to a 7-month-old, with no reported adverse event; Initial information received on 20-Mar-2026 regarding an unsolicited valid non-serious case received from a healthcare professional (HCP). This case involves a 7-month-old male patient to whom expired diphtheria-15/tetanus/5 acellular pertussis vaccine (DAPTACEL) administered with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided. On 19-Mar-2026, the patient received expired 0.5 mL once 2nd dose of diphtheria-15/tetanus/5 acellular pertussis vaccine [DAPTACEL] (suspension for injection) (batch: 3CA20C1, expiry: 28-Feb-2026) (strength: standard) via intramuscular route in left vastus lateralis for immunization (Immunisation) with no reported adverse event (Expired product administered, latency: same day). . Medical assistant wanted to see if this would still be valid or not. There were no reactions in the office. No other vaccines were administered. 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