Report #2865324

Overview

Sex

Female

Age

Age unknown

State

VA

Recovered

Unknown

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (2)

Symptom narrative

Suspected vaccination failure; she had one-sided, mild shingles two or three times; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 81-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 (intramuscular, left arm) and the 1st dose of Shingrix (intramuscular, left arm). On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: she had one-sided, mild shingles two or three times). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown. 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: 06-OCT-2025 The patient had one-sided, mild shingles two or three times, after receiving the two dose Shingrix vaccine. The patient stated these reoccurrences happened 3 or 4 years after receiving the two dose Shingrix series. The patient stated that she got a bump or two that starts like a mosquito bite, was annoying, that did not go away right away, but stays and stays. The patient stated it was a minor eruption that she experienced, and she knew that she would need to slow down and watch stress. The patient did not have any dates, lot/expiry for either Shingrix dose, and states both doses were probably administered in her left arm. The batch number was not provided and a request for this information has been made. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, more than 2 years after receiving Shingrix and Shingrix, in an 81-year-old female patient. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought.