Received Mar 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 4 | UK093AB | OT / RL |
administration of ACTHIB with the wrong diluent with no reported ae; Initial information received on 17-Mar-2025 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to US-SA-2025SA079766. This case involves a 15 months old female patient who had administration of HIB (PRP/T) vaccine [ACT-HIB] with the wrong diluent with no reported AE (adverse event). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Influenza vaccine (Flu) for Immunisation; and (Pneumococcal vaccines) for Immunisation. On 13-Mar-2025, the patient received a 0.5ml dose 4 of suspect HIB (PRP/T) vaccine (lot UK093AB) Powder and solvent for solution for injection standard strength, frequency-once (expiry date-30-Sep-2025) via intramuscular route in the right vastus lateralis for immunization and with the wrong diluent with no reported ae (product preparation error) (latency-same day). Reportedly-Nurse called to get information about reconstituting ACTHIB with a different diluent (sterile water), which was administered to 2 patients. 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-2025SA079766:
FLU [INFLUENZA VACCINE]; PNEUMOCOCCAL VACCINE