Received Apr 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; got a small episode of Shingles; I could not sleep; 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, several years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: got a small episode of Shingles) and difficulty sleeping (Verbatim: I could not sleep). The outcome of the vaccination failure, shingles and difficulty sleeping were not reported. It was unknown if the reporter considered the vaccination failure, shingles and difficulty sleeping 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 and difficulty sleeping to be related to Shingles vaccine. Additional Information: GSK receipt date: 23-APR-2025 This case was reported by a patient via interactive digital media. Patient stated that he/she got the vaccine. Then several years after patient got the vaccine, got a small episode of Shingles. Patient indicated that it was painful and he/she could not sleep. Also stated it would have been horrible if he/she had not been vaccinated. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding 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 completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine. US-GSK-US2025AMR016049:same patient differen suspect