Received Jun 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | — |
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | — |
Suspected Vaccination failure; Shingles suffering with eye; both shots and came down with shingles; 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. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: Shingles suffering with eye) (serious criteria GSK medically significant) and shingles (Verbatim: both shots and came down with shingles). The outcome of the vaccination failure and shingles were not reported and the outcome of the ophthalmic herpes zoster was not resolved. It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 13-JUN-2025 This case was reported by a patient via interactive digital media. The patient had both shots and came down with shingles. 2 years later still suffering with eye. They thought he/she was going to lose eyesight. Thank heavens he/she did not. Still in pain every day with eye. This case was considered as suspected vaccination failure as details regarding time to onset for shingles 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 time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2). Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2).