Report #2885590

Overview

Sex

Unknown

Age

Age unknown

State

MD

Recovered

Unknown

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (2)

Symptom narrative

ACT-HIB was reconstituted with sterile water instead of saline, with no reported adverse event; Initial information received on 10-Feb-2026 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who was reconstituted with HIB (PRP/T) VACCINE [ACT-HIB] sterile water instead of saline, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection (lot UK233AA and expiry date- 30-JUN-2026) via unknown route in unknown administration site for Immunization who was reconstituted with sterile water instead of saline, with no reported adverse event (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.