Received Nov 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | 4 | 3CA03C3 | OT / RL |
daptacel vaccine was given after expiration date 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 was linked to US-SA-2025SA343084 (cluster case). This case involves a 2 years old female patient who received diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] after expiration date with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. List concomitant: No concomitant immunizations On 02-Oct-2025, the patient received 0.5 ml of dose 4 of an expired diphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection with standard strength (expiry date- 30-SEP-2025 and lot 3CA03C3) via intramuscular route in the right vastus lateralis for Immunization with no reported adverse event (expired product administered) (latency- same day). 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-2025SA343084:cluster case