Received May 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | — | — |
compounding ACTHIB vaccine with 0.4% Sodium Chloride as the pharmacist stated they do not have the diluent that was provided with ACTHIB vaccine with no AE; Initial information regarding this unsolicited valid non-serious case downloaded from database without narrative (level 2A), was received on 20-May-2026 from Health Authorities via Health Care Professional - Pharmacist. The following narrative is based on the information retrieved from all other accessible data. This case involves an unknown age patient of unknown gender who was compounded to ACTHIB vaccine with 0.4% Sodium Chloride as the pharmacist stated they did not have the diluent that was provided with ACTHIB vaccine with no adverse event. The patient's past medical history, past drugs, vaccination(s), family history, concomitant medications were not provided. On an unknown date, the patient was to receive an unknown dose of HIB (PRP/T) Vaccine [ACT-HIB], Powder and solvent for solution for injection (batch: unknown, expiration date: unknown) (strength: unknown) via unknown route and unknown administration site for immunization (Immunisation). The pharmacist clarified that the diluent was manually pulled from another one of their hospitals and was inadvertently not put in the bag. The pharmacist inquired about compounding ACTHIB vaccine with 0.4% Sodium Chloride as the pharmacist stated they did not have the diluent that was provided with ACTHIB vaccine (Product preparation issue, onset date: unknown, latency: unknown). The pharmacist seemed to be in a hurry and stated the patient had been at the clinic for 20 to 30 minutes and the pharmacist was trying to get them in and out of the door. Medical information specialist (MIS) asked if diluent was not provided in the package with the ACTHIB vaccine. The pharmacist clarified that the diluent was manually pulled from another one of their hospitals and was inadvertently not put in the bag. MIS referenced SRD: Use of Alternate Diluents. The pharmacist asked again if they could compound their own 0.4% Sodium Chloride since they did not have the diluent vial. It was confirmed that the patient did not receive any ACTHIB vaccine prepared in error. 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