Received Aug 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK201AC | OT |
ACTHIB reconstituted with incorrect diluent, nurse used 0.9% Normal Saline with ACTHIB instead of the provided Diluent with no reported AE; Initial information received on 06-Aug-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 48 years old male patient who received HIB (PRP/T) Vaccine [Act-Hib] which was reconstituted with incorrect diluent, nurse used 0.9% normal saline instead of the provided diluent with no reported adverse event. The patient's past medical history included Splenectomy in 2025. The patient's past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Meningococcal vaccine polysacch (Meningococcal polysaccharide) for Immunisation. On 05-Aug-2025, the patient received 0.5ml dose of suspect Hib (Prp/T) Vaccine, Powder and solvent for solution for injection, (frequency once) Strength Standard, lot UK201AC and expiry date Apr-2026 via intramuscular route in the deltoid NOS (not otherwise specified) for immunization, which was reconstituted with incorrect diluent, nurse used 0.9% normal saline instead of the provided diluent with no reported ae (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.
Medical History/Concurrent Conditions: Splenectomy
Meningococcal polysaccharide