Received Oct 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK231AA | OT |
states the dose was reconstituted with normal saline, not the diluent that was included in the factory package with no adverse event; Initial information received on 02-Oct-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown age and unknown gender patient who was administered with Hib (Prp/T) Vaccine [Act-Hib], which was reconstituted with normal saline, not the diluent that was included in the factory package with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date In Sep-2025, the patient received an unknown dose of suspect Hib (Prp/T) Vaccine, Powder and solvent for solution for injection, lot UK231AA, expiry date:30-Jun-2026, strength not reported via unknown route in unknown administration site for Immunization ,which was reconstituted with normal saline, not the diluent that was included in the factory package with no adverse event (product preparation error) (latency: same day). Reportedly,The dose was given sometime in the last 4 weeks. 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.