Report #2853679

Overview

Sex

Female

Age

1 yrs

State

DE

Recovered

Unknown

Vaccinated

Jul 1, 2025

Onset

—

Days to onset

—

Hospital days

—

Symptoms (2)

Symptom narrative

ACT-HIB was reconstituted with sterile water and administered to a patient with no reported adverse event; Initial information received on 06-Aug-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 1 years old female patient received HIB (PRP/T) vaccine [ACT-HIB] was reconstituted with sterile water and administered to a patient with no reported adverse event. The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided. On an unknown date in Jul-2025, the patient received dose 4 of 0.5 ml of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection of standard strength, frequency once with lot UK210AA and expiry date 28-Feb-2026 via intramuscular route in unknown administration site that was reconstituted with sterile water and administered to a patient with no reported adverse event (product preparation error) (latency same day) Reportedly, Nurse stated that they found a vial of saline diluent they believe goes with the HIB part of the vaccine, meaning they believe that part may have been reconstituted with sterile water, not the provided diluent. 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.