Report #2846775

Overview

Sex

Unknown

Age

Age unknown

State

TX

Recovered

Unknown

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (2)

Symptom narrative

given the PENTACEL but without the HIB component with no reported adverse event; Initial information received on 18-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient gives the diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (Vero) but without the hib component 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 diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine with unknown formulation and strength (lot UK225AB with expiry date 31-JUL-2026) via unknown route in unknown administration site for Immunization; without the hib component with no reported adverse event (poor quality product administered) (unknown latency). Reportedly: The staff member may have used a sterile diluent. Caller verified that the liquid component was not administered. 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.