Report #2832617

Overview

Sex

Female

Age

Age unknown

State

—

Recovered

Not recovered

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (2)

Symptom narrative

Suspected vaccination failure/Shingrix ineffective; Patient got two doses of HZV and developed shingles later; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure/Shingrix ineffective) (serious criteria GSK medically significant) and shingles (Verbatim: Patient got two doses of HZV and developed shingles later). The outcome of the vaccination failure was not resolved and the outcome of the shingles was not reported. The reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. The company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date : 14-MAR-2025 Patient got two doses of HZV (herpes zoster vaccine) and developed shingles later. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (dose 1) and Shingrix (dose 2).