Received Mar 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | 1 | 3CA11C1 | OT / LL |
administered a dose of DAPTACEL too early to underaged patient (7-days-old) with no reported adverse event; Initial information received on 04-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to US-SA-2025SA067387. This case involves a 7 days old female patient who was administered with diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] at underage 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 HIB Vaccine Conj (Tet Tox) (ACT-HIB) for Immunisation. On 02-Mar-2025 the patient was administered 0.5ml (once) dose 1 of diphtheria-15/tetanus/5 AC pertussis vaccine, Suspension for injection, Standard strength, Expiry date 31-Dec-2025 and lot 3CA11C1 via intramuscular route in the left thigh for immunization too early at underage (7-days-old) with no reported adverse event (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.; Sender's Comments: US-SA-2025SA067387:ACT-HIB
ACTHIB