Received May 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | 5 | 3CA20C1 | OT / LA |
7 years old received Daptacel on not approved age group with no reported adverse event; Initial information received on 13-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 7-year-old female patient who received diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] to not approved age group 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) for Immunisation. On 06-May-2025, the 7 years old patient received a 0.5 (ml) dose (dose 5) of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine Suspension for injection strength: standard, frequency: once of lot 3CA20C1 and expiry date: 28-Feb-2026 via intramuscular route in the left arm for Immunization to not approved age group with no reported adverse event (product administered to patient of inappropriate age) (latency: on same day). Reportedly, She further asked if a Tdap (Tetanus, Diphtheria, and acellular Pertussis) would have to be given. 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