Received Jun 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK201AC | OT / RL |
inappropriate use due to a nurse accidentally administering ACT-HIB reconstituted with only sterile water as diluent to a patient with no reported adverse event; Initial information received on 17-Jun-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 1 years old male patient who had inappropriate use due to a nurse accidentally administering HIB (PRP/T) vaccine [ACT-HIB] reconstituted with only sterile water as diluent to a patient 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 (Daptacel) for Immunisation. On 11-Jun-2025, the patient accidentally administering an unknown dose (0.5ml) of suspect HIB (PRP/T) vaccine; Powder and solvent for solution for injection with strength: standard (lot UK201AC with expiry date 20-APR-2026) via intramuscular route in the right thigh for Immunization; act-hib reconstituted with only sterile water as diluent to a patient with no reported adverse event (product preparation error) (latency: same day) Reportedly: patient was Not pregnant. Patient age was less then 1 year. their nurses accidentally administered ACT-HIB reconstituted using only sterile water as diluent to a patient. She called to check if this was considered as a valid dose. 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.
DAPTACEL