Received Nov 22, 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; 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 covid-19 (patient caught Covid last time on an unknown date) and influenza (patient caught flu last time on an unknown date). On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On 02-NOV-2025, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: Shingles). The patient was treated with amoxicillin and metronidazole (Flagyl). The outcome of the vaccination failure was not reported and the outcome of the facial herpes zoster was resolving. It was unknown if the reporter considered the vaccination failure and facial herpes zoster 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 facial herpes zoster to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK receipt date: 14-NOV-2025 The case was received from the patient via interactive digital media. The patient had both shingles shots and woke up 02-NOV-2025 with a burning sore over the left eyebrow. The patient soon developed another one next to it and bumps above it on the forehead. They actually turned black surrounded by very red inflamed and swollen into the eyelid. The patient was not feeling very well either bad headache. The patient took a picture sent it to the doctor. The patient was told to go to urgent care they said it was a spider bite and needed to go to emergency room. On 13-NOV-2025, the doctor got the patient in, and it was shingles, but he said the virus was probably gone and he did not give the antiviral medicines. It was not swollen, and the burning was not quite as bad but being on the face, bothers the patient hope it would get better. The patient was on amoxicillin and flagyl so that helped and having had the shots probably helped that it did not cover more of the face. 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 facial herpes zoster were unknown at the time of reporting.; Sender's Comments: A case of Vaccination failure, an unknown time after receiving 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 events were caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received
Medical History/Concurrent Conditions: COVID-19 (patient caught Covid last time on an unknown date); Influenza (patient caught flu last time on an unknown date)