Received May 26, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
suspected vaccination failure; shingles case after complete Shingrix scheme; late 2nd dose; This serious case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. In JUN-2024, the patient received the 2nd dose of Shingrix. On 18-DEC-2018, the patient received the 1st dose of Shingrix. In JUN-2024, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: late 2nd dose). On an unknown date, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles case after complete Shingrix scheme). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown and the outcome of the drug dose administration interval too long was not applicable. 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: 20-MAY-2026 The reporter stated that patient had shingles case after completing the Shingrix scheme. This case was considered as suspected vaccination failure as details, 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. This case is one of the three linked cases reported by the same reporter.; Sender's Comments: A case of Vaccination failure, on an unknown time after vaccination with the 1st dose of Shingrix and the 2nd dose of Shingrix, in a 77-year-old 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.