Received Apr 7, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | UK331AA | — |
administration of acthib reconstituted with sterile water with no reported ae; Initial information received on 16-Mar-2026 regarding an unsolicited valid non-serious case received from a healthcare professional. This case involves an unknown age patient of unknown gender who was administered with Hib (Prp/T) Vaccine, Powder and solvent for solution for injection reconstituted with sterile water with no reported adverse event. On an unknown date, the patient received an unknown dose of suspect Hib (Prp/T) Vaccine, Powder and solvent for solution for injection, Frequency = Once, batch number:UK331AA, Expiration Date 30-Jun-2026, strength: standard for Immunization, which was reconstituted with sterile water with no reported adverse event (Product preparation error) (latency: same day). It was reported "Clinic manager sought guidance following the administration of ACTHIB reconstituted with sterile water. They noted that while they received both vials for the lyophilized vaccine component as well as for the accompanying saline diluent, a patient may have received the ACTHIB prepared not with the diluent supplied in the box but with sterile water instead". Action taken: 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.
Comments: NONE