Received May 8, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
Suspected vaccination failure/Lack of drug effect; diagnosed with shingles on his face; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 59-year-old 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, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure/Lack of drug effect) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: diagnosed with shingles on his face). The outcome of the vaccination failure was unknown and the outcome of the facial herpes zoster was not reported. It was unknown if the reporter considered the vaccination failure and facial herpes zoster 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 facial herpes zoster to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date:30-APR-2026 The patient had both injections of Shingrix administered in the recommended intervals. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles and time to onset 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 on an unknown time after vaccination with the 2nd dose of Shingrix and the 1st dose of Shingrix, in a 59-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.