Report #2885588

Overview

Sex

Unknown

Age

Age unknown

State

OH

Recovered

Unknown

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (1)

Symptom narrative

reconstituting the ActHib component of PENTACEL using a different diluent, and not the DTAP-IPV component of the vaccine; Initial information received on 09-Feb-2026 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who received only Act-Hib component of the Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] which was reconstituted using a different diluent, and not the DTap-IPV 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 only Act-Hib component of the Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine (Once), Unknown formulation, Strength Standard, lot UK364AA and expiry date 31-Mar-2027 via unknown route in unknown administration site for Immunization, which was reconstituted using a different diluent, and not the DTap-IPV component with no reported adverse event (single component of a two-component product administered) (latency Same day). It was reported, "the powder component was reconstituted using a diluent that's given typically with MMR or Varicella vaccine. The reconstituted ActHib component was given to the patient. However, the DTaP-IPV component has not yet been given." 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.