Received Aug 28, 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; shingles in my right eye again; 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. The patient's past medical history included shingles (had shingles on scalp) and ophthalmic herpes zoster (had shingles in right eye, eyelid was affected). On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 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: shingles in my right eye again) (serious criteria GSK medically significant). 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 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: 19-AUG-2025 This case was reported by a patient via interactive digital media. The patient said that his/her physician told him/her once you have had shingles it was in your system, and the shot would not help. The patient had shingles on his/her scalp and in right eye, finally recovered after a few months but his/her eyelid was affected, got the 2 Shingles shots and 2 years later, in his/her right eye again. This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of 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 and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (dose 1) and Shingles vaccine (dose 2). A case of Ophthalmic herpes zoster, 2 years after receiving Shingles vaccine, in a patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received.
Medical History/Concurrent Conditions: Ophthalmic herpes zoster (had shingles in right eye, eyelid was affected); Shingles (had shingles on scalp)