Received Apr 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; eye 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. 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) and ophthalmic herpes zoster (Verbatim: eye shingles) (serious criteria GSK medically significant). The patient was treated with prednisone. The outcome of the vaccination failure and ophthalmic herpes zoster were not reported. It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine. The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 31-MAR-2025 This case was reported by the patient via interactive digital media. The patient reported no one told you that it (eye shingles) could cause double vision, and it paralyzed your cranial nerves behind the eye. Because the patient had his/her shots 2 years ago in 2023 (from the date of reporting) and he/she was able to take prednisone and get his/her vision back to normal. However, without the Shingrix shots you would not get better. This was a terrible fate without the shots. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming 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 the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine."