Received Nov 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | RA |
she was diagnosed with ocular shingles in her right eye; This serious case was reported by a consumer and described the occurrence of ophthalmic herpes zoster in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (Consumer does have a positive past history of shingles outbreaks). Previously administered products included Zostavax (Consumer states she was vaccinated with Zostavax years ago). On an unknown date, the patient received the 1st dose of Shingrix (right arm). On an unknown date, 1 week after receiving Shingrix, the patient experienced ophthalmic herpes zoster (Verbatim: she was diagnosed with ocular shingles in her right eye) (serious criteria GSK medically significant). The patient was treated with Antivirals. The outcome of the ophthalmic herpes zoster was not reported. It was unknown if the reporter considered the ophthalmic herpes zoster to be related to Shingrix. The company considered the ophthalmic herpes zoster to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 05-NOV-2025 Consumer was the reporter. Consumer stated she received her first dose of Shingrix and one week later she was diagnosed with ocular shingles in her right eye. Consumer did not have a positive past history of shingles outbreaks. Consumer stated she was vaccinated with Zostavax years ago. Consumer reported the past June she had a mild outbreak on her trunk. Consumer stated she knows what to do when she has an outbreak and will use lidocaine patches and takes an antiviral medication. The consumer stated she is using an eye drop for her ocular shingles. Consumer stated she was in pain and did not want to lose vision in her eye.; Sender's Comments: A case of Ophthalmic herpes zoster,1 week after receiving 1st dose of Shingrix, in a 71-year-old female patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought.
Medical History/Concurrent Conditions: Shingles (Consumer does have a positive past history of shingles outbreaks)