Report #2896685

Overview

Sex

Female

Age

Age unknown

State

FL

Recovered

Not recovered

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (2)

Symptom narrative

suspected vaccination failure; Recurrent, breakthrough shingles; This serious case was reported by a pharmacist via sales rep and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (patient had recurrence of shingles). On an unknown date, the patient received the 2nd dose of Shingrix (unknown deltoid) and the 1st dose of Shingrix (unknown deltoid). 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: Recurrent, breakthrough shingles). The patient was treated with Antivirals. 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: 05-MAY-2026 The patient who was a pharmacist healthcare provider, was aged in the 60s. The patient reported that she had experienced multiple cases of shingles both before and after completing the Shingrix 2-dose series. The patient stated that these episodes were not serious but recurrent, and that antivirals did not seem to be effective once the infection became active. The recurrent shingles breakthrough was reported as worsened. 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 time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, unknown time after receiving 2nd dose of Shingrix and the 1st dose of Shingrix, in a 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.

Medical history

Medical History/Concurrent Conditions: Shingles (patient had recurrence of shingles)