Received Apr 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
Suspected vaccination failure; shingles on the left side of her face and neck and it affected the vision in her left eye; she got shingles on the left side of her face and neck; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, several months after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: shingles on the left side of her face and neck and it affected the vision in her left eye) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: she got shingles on the left side of her face and neck). The outcome of the vaccination failure, ophthalmic herpes zoster and facial herpes zoster were not reported. It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and facial herpes zoster to be related to Shingrix and Shingrix. The company considered the vaccination failure, ophthalmic herpes zoster and facial herpes zoster to be unrelated to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 08-APR-2025 This case was reported by a patient's nephew/niece via interactive digital media. The patient got both doses of the Shingrix shot and a few months after the second shot she got shingles on the left side of her face and neck and it affected the vision in her left eye and the shots did not helped her. This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of 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 and laboratory confirmation of disease) is considered unrelated to GSK Shingrix Herpes zoster and Ophthalmic herpes zoster are unlisted events which are considered unrelated to GSK vaccine Shingrix."