Received Mar 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | UNK | 2CA77C1 | OT |
vaccine didn't go into the patient and it was noted on outside of the patient's leg with no reported adverse event; vaccine didn't go into the patient and it was noted on outside of the patient's leg with no reported adverse event; Initial information received on 19-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 months old male patient who was receiving diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] that didn't go into the patient and it was noted on outside of the patient's leg with no reported adverse event and vaccine didn't go into the patient and it was noted on outside of the patient's leg with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 18-Mar-2025, Caller reported that diphtheria-15/tetanus/5 AC pertussis vaccine, Suspension of injection, (Unknown strength) lot 2CA77C1 with expiry date 30-Apr-2025, for immunization, which didn't go into the patient and it was noted on outside of the patient's leg with no reported adverse event (accidental exposure to product) (exposure via skin contact). Reportedly. They were using the VanishPoint needle, a needle that retracts into the syringe after injection.They ended up giving the patient another dose of DAPTACEL yesterday after she discussed it with the doctor. 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.