Report #2892946

Overview

Sex

Male

Age

Age unknown

State

MN

Recovered

Unknown

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (1)

Symptom narrative

Incorrect diluent used to reconstitute vaccine. Sterile water was used instead of Nacl with no reported ae; Initial information received on 01-Apr-2026 regarding an unsolicited valid non-serious case received from nurse. This case involves a 17-month-old male patient who had ACT-HIB with incorrect diluent used to reconstitute vaccine: sterile water was used instead of Sodium Chloride (NaCl) with no reported adverse event. On an unknown date, the patient received a 0.5 mL dose of ACTHIB (ACT-HIB) [Powder and solvent for solution for injection] (batch/lot number: UK331AA, expiration date: Jul-2026) (strength: unknown) via intramuscular route in unknown vaccination site for prophylactic vaccination [Immunisation]. Incorrect diluent used to reconstitute vaccine. Sterile water was used instead of Sodium Chloride (NaCl) with no reported adverse event [(Product preparation error, Onset: unknown, Latency: unknown)]. Parents of the patient have been informed of the need to repeat the vaccine. 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.

Medical history

Comments: NONE