Received May 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | 6 | 3CA20C1 | OT / RA |
7-year-old patient who received DAPTACEL. It is an extra dose with no reported adverse event; 7-year-old patient who received DAPTACEL. It is an extra dose with no reported adverse event; Initial information received on 08-May-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 7 years old male patient who received diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] which was an extra dose with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Measles Vaccine, Mumps Vaccine, Rubella Vaccine (MMR); Polio Vaccine Inact (IPV) and varicella zoster vaccine (Varicella Vaccine) all for Immunisation. On 02-Apr-2025, the patient received a dose 6 of 0.5 ml of suspect diphtheria-15/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot: 3CA20C1; expiry date: 28-Feb-2026; frequency: once; strength: standard) via intramuscular route in the right deltoid for Immunisation which was an extra dose with no reported adverse event (product administered to patient of inappropriate age) (extra dose 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.
MMR; IPV; VARICELLA VACCINE