Received Feb 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 2 | UK210AA | OT |
received a dose of act-hib that had been reconstituted with sterile water instead of the intended act-hib specific diluent with no reported adverse event; Initial information received on 10-Feb-2025 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 5-month-old female patient who experienced received a dose of HIB (PRP/T) vaccine [ACT-HIB that had been reconstituted with sterile water instead of the intended specific 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 Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus Vaccine toxoid (DTAP) for Immunisation. On 06-Feb-2025, a patient received a (0.5ml) dose 2 of suspect HIB (PRP/T) Vaccine powder and solvent for solution for injection (strength-unknown) (Frequency = once) (lot UK210AA) (Expiry date- 28-Feb-2026) via intramuscular route in right leg for Immunization, that had been reconstituted with sterile water instead of the intended specific diluent 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