Received May 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspeceted vaccination failure; had shingle twice and the autoimmune disease from the vaccine is worse; I have had shingle twice and the autoimmune disease from the vaccine is worse; 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. 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: Suspeceted vaccination failure) (serious criteria GSK medically significant), autoimmune disorder (Verbatim: had shingle twice and the autoimmune disease from the vaccine is worse) (serious criteria GSK medically significant) and shingles (Verbatim: I have had shingle twice and the autoimmune disease from the vaccine is worse). The outcome of the vaccination failure, autoimmune disorder and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The reporter considered the autoimmune disorder to be related to Shingles vaccine. The company considered the vaccination failure, autoimmune disorder and shingles to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 05-MAY-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she had shingle twice and the autoimmune disease from the vaccine was worse. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and 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, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Herpes zoster and Autoimmune disorder are unlisted events which are considered unrelated to GSK Shingles vaccine. "