Received Apr 14, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
Suspected vaccination failure; recently diagnosed with shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a male 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, 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: recently diagnosed with shingles). The outcome of the vaccination failure was unknown, and the outcome of the shingles was not reported. 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-APR-2026 The patient was vaccinated with Shingrix both series in 2018 and 2019. He stated he was recently diagnosed with shingles, and his healthcare professional diagnosed his case as mild. 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. The batch number was not provided upon follow- up with the reporter.; Sender's Comments: A case of Vaccination failure, more than 2 years after vaccination with the 2nd dose of Shingrix and the 1st dose of Shingrix, in a male patient. Based on the available information a possible causality that the event was caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received.