Received Dec 25, 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; Cut by patient eye; Stress; Fell; 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. In NOV-2025, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced fall (Verbatim: Fell). On an unknown date, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), periorbital injury (Verbatim: Cut by patient eye) and stress (Verbatim: Stress). The outcome of the vaccination failure, fall, periorbital injury and stress were not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure, shingles, fall, periorbital injury and stress to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles, fall, periorbital injury and stress to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 17-DEC-2025 This case was reported by a patient via interactive digital media. The patient had fallen around 12-Nov-2025, gone to hospital and had a cut by the eye; then two daughters, had three, had been put under a lot of stress when they got home. The patient then developed shingles, and this was the fourth time the patient had had them. The patient had thought they were having problems from the fall. They later learned it was shingles. The patient had pain over the whole left side of the face, itching in both eyes and in the head, and headaches. The patient had been miserable, had had this for weeks, and had not known what it was until the previous night when a daughter said it might be shingles. The batch number was not provided and unable to contact the reporter. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, an unknown time after receiving the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine, in a patient. Causal association is indeterminate. Based on the available information a possible causality that the event was caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received