Received Jun 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; Shingles a year later in my left eye; shingles a year later on the left part of my head; had a bad fall; hematoma in left eye; 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, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: Shingles a year later in my left eye) (serious criteria GSK medically significant), shingles (Verbatim: shingles a year later on the left part of my head), fall (Verbatim: had a bad fall) and eye hematoma (Verbatim: hematoma in left eye). The outcome of the vaccination failure, ophthalmic herpes zoster, shingles, fall and eye hematoma were not reported. It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles, fall and eye hematoma 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, fall and eye hematoma to be related to Shingles vaccine. Additional Information: GSK receipt date: 09-JUN-2025 This case was reported by a patient via interactive digital media. Patient had shingles shots and got shingles a year later on the left part of head and in left eye. Physician said patient would have been screaming with pain, if it weren't for the fact that patient had shots. The virus attacks areas where immunity is the lowest, especially on the head. Patient had a bad fall 7 months earlier that resulted in a hematoma over left eye. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, 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, time to onset, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine