Received May 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 3 | UK148AA | OT / RL |
reconstituted ACT-HIB with sterile water with no reported adverse event; reconstituted ACT-HIB with sterile water and administered it to a patient; Initial information received on 19-May-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 months old with unknown gender patient who was administered with reconstituted HIB (PRP/T) Vaccine [ACT-HIB] with sterile water 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 Pediarix, Rotavirus vaccine and Prevnar 20 for Immunisation. On 14-May-2025, the patient received 0.5mL (dose 3) (frequency once) of suspect HIB (PRP/T) Vaccine, Powder and solvent for solution for injection (lot UK148AA, expiry date 30-Sep-2025, strength standard) via intramuscular route in the right thigh for TB skin test (Immunisation) and reconstituted act-hib with sterile water and administered it to a patient (poor quality product administered), (product preparation error) (latency same day). Reportedly, reported called to ask if the ACTHIB dose needs to be repeated. They reported that one of their nurses reconstituted ACTHIB with sterile water and administered it to a patient. 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.
PEDIARIX; Rotavirus vaccine; Prevnar 20