Received Apr 30, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
Suspected vaccination failure; ophthalmic herpes zoster/Shingles were large and spread to left eye; Shingles; This serious case was reported by a consumer and described the occurrence of vaccination failure in a 66-year-old male 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 (twice in the past and both were mild). On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 12-APR-2026, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: ophthalmic herpes zoster/Shingles were large and spread to left eye) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The patient was treated with valaciclovir (Valacyclovir). The outcome of the vaccination failure was not reported and the outcome of the ophthalmic herpes zoster and shingles were not resolved. It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure and ophthalmic herpes zoster 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: 21-APR-2026 The patient visited his family doctor on 18-APR-2026 for a facial rash, skin sensitivity, and headaches. The patient had previously received the two shot Shingrix vaccine over two years earlier, so the patient did not expect to hear from the doctor that the rash was shingles after getting the vaccine. The patient had experienced shingles twice in the past, and both cases were mild; however, this episode was larger and spread to left eye. The reporter asked if he was susceptible to shingles and vaccine was considered ineffective and would not protect in future. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles was unknown at the time of reporting. The batch number was not provided and a request for this information has been made.; Sender's Comments: A case of Vaccination failure and Ophthalmic herpes zoster, more than 2 years after vaccination with the 2nd dose of Shingrix and the 1st of Shingrix, in a 66-year-old male patient. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received.
Medical History/Concurrent Conditions: Shingles (twice in the past and both were mild)