Received Feb 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK170A8 | OT / RL |
administered an act-hib vaccine with the wrong diluent with no reported adverse event; Initial information received on 03-Feb-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 11 weeks old male patient who received haemophilus type B (HIB) vaccine [ACT-HIB] with the wrong diluent 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 Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for Immunisation. On 03-Feb-2025, the patient received 0.5 ml of HIB (PRP/T) vaccine Powder and solvent for solution for injection (strength- unknown, expiry date- 31-OCT-2025 and lot UK170A8) once via unknown route in the right vastus lateralis as Immunization with the wrong diluent with no reported adverse event (product preparation error) (latency- same day). Reportedly, 0.7 mL of Merck normal saline. 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.
Prevnar 20