Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; around one eye, the virus infected my eye; I am now legally blind in that eye; developed shingles on my face; 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 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: around one eye, the virus infected my eye) (serious criteria GSK medically significant), unilateral blindness (Verbatim: I am now legally blind in that eye) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: developed shingles on my face). The outcome of the vaccination failure, ophthalmic herpes zoster and facial herpes zoster were not reported and the outcome of the unilateral blindness was not resolved. It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, unilateral blindness and facial herpes zoster to be related to Shingles vaccine. The company considered the vaccination failure, ophthalmic herpes zoster and unilateral blindness to be unrelated to Shingles vaccine. It was unknown if the company considered the facial herpes zoster to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 28-MAR-2025 This case was reported by a patient via interactive digital media. The patient had a shingles vaccine years ago that was supposed to last a lifetime. Four years ago developed shingles on face, and around one eye. The virus infected eye to the point where patient now legally blind in that eye. The patient still in the care of an ophthalmologist after numerous expensive treatments to reduce the damage. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming 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. Ophthalmic herpes zoster and Blindness unilateral are unlisted event which is considered unrelated to GSK Shingles vaccine.