Received Mar 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | UNK | 3CA25C1 | OT / LA |
Daptacel on an 88-year-old patient with no reported adverse event; Initial information received on 10-Mar-2025 regarding an unsolicited valid non-serious case received from a other healthcare professional. This case involves a 88 years old male patient who received diphtheria-15/tetanus/5 AC pertussis vaccine [daptacel] with no reported adverse event. The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided. On 27-Feb-2025, the patient received standard dose of 0.5 ml of suspect diphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection with lot 3CA25C1 and expiry date 30-Apr-2026 via intramuscular route in the left arm for Immunization (product administered to patient of inappropriate age) (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.