Received Apr 30, 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 | — |
It impacted left eye; contracted shingles across the left side of face; suspected vaccination failure; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 75-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. Concurrent medical conditions included immune system disorder. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In FEB-2025, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: contracted shingles across the left side of face). On an unknown date, the patient experienced ophthalmic herpes zoster (Verbatim: It impacted left eye) (serious criteria GSK medically significant). The outcome of the vaccination failure was not reported and the outcome of the ophthalmic herpes zoster and facial herpes zoster were resolving. It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and facial herpes zoster 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 facial herpes zoster to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 23-APR-2025 This case was reported by a patient via interactive digital media. The patient had two Shingles shots over the years, and 10 weeks ago (from the date of reporting) the patient contracted shingles across the left side of her/his face. The patient had been working too hard (author), and her/his low immune system was a factor. The patient had never been so miserable. In 2025, it (shingles) impacted her/his left eye, but patient saw an ophthalmologist and it was okay. He/she thanked the stars. It was slowly improving. The patient was told rest was key to recovery, so he/she was resting in the afternoons. The patient had been feeling sorry for herself/himself. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation regarding ophthalmic herpes zoster and facial 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 the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease; Concurrent medical conditions included immune system disorder) is considered unrelated to GSK vaccine Shingles vaccine (dose 1) and Shingles vaccine (dose 2). Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine (dose 1) and Shingles vaccine (dose 2).
Immune system disorder