Received Mar 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 1 | UK148AA | OT |
administered a dose of ACTHIB too early/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 linked to US-SA-2025SA067436. This case involves a 7 days old female patient who experienced inappropriate use as patient being administered a dose of acthib too early/underaged, was administered act-hib and daptacel with no reported adverse event after receiving HIB (PRP/T) vaccine [ACT-HIB]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel) for Immunisation. On 02-Mar-2025, the patient received a dose 1 (0.5ml) of suspect HIB (PRP/T) vaccine; Powder and solvent for solution for injection with standard strength (lot UK148AA with expiry date 30-Sep-2025) via intramuscular route in the left thigh for Immunization (Immunisation) and patient administered a dose of acthib too early/underaged patient (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-2025SA067436:ACT-HIB
DAPTACEL