Received Jul 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; Could this be shingles; spots popped out; I had burning; have had the vaccine I had burning and itching; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 70-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Could this be shingles), burning sensation (Verbatim: I had burning), pruritus (Verbatim: have had the vaccine I had burning and itching) and papule (Verbatim: spots popped out). The outcome of the vaccination failure, shingles and papule were not reported and the outcome of the burning sensation and pruritus were resolved (duration 1 week). It was unknown if the reporter considered the vaccination failure, shingles, burning sensation, pruritus and papule to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles, burning sensation, pruritus and papule to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 16-JUL-2025 This case was reported by a patient via interactive digital media. The patient reported that this could be shingles and have had the vaccine and had burning, itching and about 6 spots popped out. It was very itchy and burning for about a week. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming 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, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine