Report #2885554

Overview

Sex

Unknown

Age

Age unknown

State

—

Recovered

Unknown

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (1)

Symptom narrative

administration of pentacel to a patient that was not reconstituted with the correct diluent with no reported adverse event; Initial information received on 09-Feb-2026 regarding an unsolicited valid non-serious case received from a Non-Healthcare Professional. This case involves Child and unknown gender patient who received diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] that was not reconstituted with the correct diluent 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 unknown dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Powder and suspension for suspension for injection (Unknown strength, lot and expiry date) via unknown route in unknown administration site for Immunization that was not reconstituted with the correct diluent with no reported adverse event (product preparation error) (Latency same day). 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.