Received Jul 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK148AA | OT / LL |
given the ACTHIB vaccine but didn't dilute it with the HIB diluent/diluted it with another diluent that was for PROQUAD & VARICELLA, with no reported adverse event; Initial information received on 01-Jul-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old male patient who was administered with HIB (PRP/T) Vaccine [ACT-HIB] but didn't dilute it with the hib diluent/diluted it with another diluent that was for proquad & varicella, 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 Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Dtap), Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for and HIB vaccine (HIB vaccine) for Immunisation. On 12-Jun-2025, the patient received 0.5 ml dose of suspect Hib (Prp/T) Vaccine, Powder and solvent for solution for injection, lot UK148AA, expiry date:30-Sep-2025,strength:standard, frequency:once, via intramuscular route in the left thigh for immunisation but didn't dilute it with the hib diluent/diluted it with another diluent that was for proquad & varicella, with no reported adverse event (product preparation error) (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.
Dtap; Prevnar 20; HIB vaccine