Report #2869853

Overview

Sex

Female

Age

Age unknown

State

—

Recovered

Recovered

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (3)

Symptom narrative

Suspected vaccination failure; HZ breakthrough case; Vaccine administered to patient under recommended age; This serious case was reported by a pharmacist via sales rep and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), herpes zoster (Verbatim: HZ breakthrough case) (serious criteria other: serious as per reporter) and inappropriate age at vaccine administration (Verbatim: Vaccine administered to patient under recommended age). The outcome of the vaccination failure was not reported and the outcome of the herpes zoster was resolved and the outcome of the inappropriate age at vaccine administration was not applicable. The reporter considered the vaccination failure and herpes zoster to be unrelated to Shingrix. The company considered the vaccination failure and herpes zoster to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 28-OCT-2025 This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The batch number was not provided, and we are unable to contact the reporter.; Sender's Comments: A case of Vaccination failure and Herpes zoster, unknown time after receiving Shingrix, in a adult female patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received.