Received Apr 8, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | UNK | 3CA20C1 | IM / RL |
accidentally administered daptacel two days after the expiration date, with no reported adverse event; Initial information received on 02-Mar-2026 regarding an unsolicited valid non-serious case received from other or unknown healthcare professional (HCP). This case involves a 1 year 6 month old female patient who was accidentally administered diphtheria toxoid, acellular pertussis vaccine and tetanus toxoid (DAPTACEL) two days after the expiration date, with no reported adverse event. The patient's past medical history, past medical treatment(s), past drugs, vaccination(s) and family history were not provided. Concomitant medication(s) included Havrix. On 02-Mar-2026, the patient received diphtheria toxoid, acellular pertussis vaccine and tetanus toxoid suspension for injection as 0.5 mL dose (dose 4) strength: standard once via intramuscular route in right thigh for immunization two days after the expiration date, with no reported adverse event (expired product administered, latency: same day) (batch: 3CA20C1, expiry: 28-Feb-2026). 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
Havrix