Received Aug 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
It affected my right eye; singles beginning 9/19/24 on my forehead on the right side; Suspected vaccination failure; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On 19-SEP-2024, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: singles beginning 9/19/24 on my forehead on the right side). On an unknown date, the patient experienced ophthalmic herpes zoster (Verbatim: It affected my right eye) (serious criteria GSK medically significant). 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 : 08-AUG-2025 This case was reported by a patient via interactive digital media. Patient had singles beginning 19th September 2024 on his/her forehead on the right side. It affected his/her right eye. It was nearly one year and he/she still had a red mark over his/her eyebrow and itching. If patient had not been vaccinated it would have been much worse. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. A case of Ophthalmic herpes zoster, unknown time after receiving Shingles vaccine, in a patient. Based on the available information a possible causality that the events was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received.