Report #2868913

Overview

Sex

Unknown

Age

1 yrs

State

UT

Recovered

Unknown

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (2)

Symptom narrative

had administered and expired dose of PENTACEL to a 1-year-old patient with no reported adverse event; Initial information received on 23-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old and unknown gender patient who received an expired dose of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel] 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 expired dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for immunisation, with no reported adverse event (expired product administered) (latency Same day). Information regarding batch number corresponding to the one at time of event occurrence is requested. 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.