Received Mar 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 3 | UK093AB | OT / LL |
ACT-HIB was administrated with a different diluent (sterile water), with no adverse event; 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-2025SA079793. This case involves a 1 years old male patient who received HIB (PRP/T) VACCINE [ACT-HIB] with a different diluent (sterile water), with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Immunisation. On 14-Mar-2025, the patient received a 0.5ml dose 3 of suspect HIB (PRP/T) VACCINE, Powder and solvent for solution for injection (lot UK093AB and expiry 30-Sep-2025) standard strength, frequency-once via intramuscular route in the left vastus lateralis for immunization with a different diluent (sterile water), with no adverse event (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. 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-2025SA079793:02451344
HEPATITIS A