Report #2858371

Overview

Sex

Unknown

Age

Age unknown

State

—

Recovered

Not recovered

Vaccinated

Dec 1, 2023

Onset

—

Days to onset

—

Hospital days

—

Symptoms (4)

Symptom narrative

Suspected vaccination failure; severe shingles rash and muscle aches in my right arm; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. In MAR-2024, the patient received the 2nd dose of Shingrix. In DEC-2023, the patient received 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) (serious criteria GSK medically significant) and shingles (Verbatim: severe shingles rash and muscle aches in my right arm). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if 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. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK receipt date: 29-AUG-2025 Patient received Shingrix shots two years ago and on Tuesday developed a severe shingles rash and muscle aches in right arm. This case was considered as suspected vaccination failure as details regarding laboratory confirmation and time to onset of shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, an unknown time after receiving Shingrix (dose 1) and Shingrix (dose 2), in a 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.