Received Apr 9, 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 | — |
Suspected vaccination failure; severe pain in eye, diagnosed with a big dry patch on cornea, treated with Valtrex like it was 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. On an unknown date, more than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and ophthalmic herpes zoster (Verbatim: severe pain in eye, diagnosed with a big dry patch on cornea, treated with Valtrex like it was Shingles) (serious criteria GSK medically significant). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure was not reported and the outcome of the ophthalmic herpes zoster was resolving. It was unknown if the reporter considered the vaccination failure and ophthalmic 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. Additional Information: GSK Receipt Date: 28-Mar-2025 This case was reported by a patient via interactive digital media. The patient got shingles vaccine and had no complications or after effects. Two months ago, the patient had severe pain in eye. The patient went to the ophthalmologist and was diagnosed with a big dry patch on cornea so they treated the patient with Valtrex like it was shingles. And it felt better in a few days. The patient had these shots two years before this episode. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments: Ophtalmic herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2). Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2).