Report #2853550

Overview

Sex

Female

Age

Age unknown

State

FL

Recovered

Recovered

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (2)

Symptom narrative

Suspected vaccination failure; Break through case of shingles; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included immunocompromised (Immunocompromised patient with kidney disease) and renal disease (Immunocompromised patient with kidney disease). On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Break through case of shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved. The reporter considered the vaccination failure and shingles to be unrelated to Shingrix. The company considered the vaccination failure and shingles to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 04-AUG-2025 Physician reported that patient had Break through case of shingles. The reporter also mentioned patient was immunocompromised with kidney disease. Patient was taking 2 immunosuppressive medications for her kidney disease. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.

Current illness

Immunocompromised (Immunocompromised patient with kidney disease); Renal disease (Immunocompromised patient with kidney disease)