Received Jul 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
suspected vaccination failure; twice in the eye; I have had shingles 3 times once on the body; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: twice in the eye) (serious criteria GSK medically significant) and shingles (Verbatim: I have had shingles 3 times once on the body). The outcome of the vaccination failure, ophthalmic herpes zoster and shingles were not reported. It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingles vaccine. The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 20-JUL-2025 This case was reported by a wife of the patient via interactive digital media. She had received the shot a while ago and she had shingles three times once on her body and twice in her eye. This year was the third time. The episodes in her eyes were worse than the one on her body. It felt like someone was sticking a screwdriver in her eye. The reporter tried to get ointment this year, but it was over dollar 500 and her insurance did not cover it. She eventually got eye drops, which shea had to use four to six times a day. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding ophthalmic herpes zoster and shingles were unknown at the time of reporting. This case was linked with US2025AMR094239 reported by same reporter.; Sender's Comments: A case of Ophthalmic herpes zoster, unknown time after receiving Shingles vaccine, in a female patient. Based on the available information a possible causality that the events were caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. US-GSK-US2025AMR094239:same reporter