Received Apr 10, 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 | — |
my vision is blurry in my right eye; Suspected vaccination failure; shingles including my eye; On the right side of my head had 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. In DEC-2024, 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 including my eye) (serious criteria GSK medically significant) and shingles (Verbatim: On the right side of my head had shingles). On an unknown date, the patient experienced blurred vision (Verbatim: my vision is blurry in my right eye). The outcome of the vaccination failure, ophthalmic herpes zoster and shingles were not reported and the outcome of the blurred vision was not resolved. It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles and blurred vision 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 and blurred vision to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 03-APR-2025 This case was reported by a patient via interactive digital media. The patient self reported this case for himself/herself. Patient had received the two shot vaccine four years earlier and developed shingles in December 2024. The shingles affected the right side of his/her head, including his/her eye. By April 2025, his/her vision in the right eye remained blurry, and he/she were still on medication. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and ophthalmic herpes zoster and laboratory confirmation regarding shingles and ophthalmic herpes zoster 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 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).