Received Apr 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspeceted vaccination failure; pericarditis; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male 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), pericarditis (Verbatim: pericarditis) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure, pericarditis and shingles were not reported. It was unknown if the reporter considered the vaccination failure, pericarditis and shingles to be related to Shingles vaccine. The company considered the vaccination failure and pericarditis to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 19-APR-2025 This case was reported by a consumer via interactive digital media. The reporter reported that reporter son got the shingles and pericarditis after the jab. The doctor told him so. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. This case has been linked to the US2023AMR040441 case reported by the same reporter.; 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. Pericarditis is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine. US-GLAXOSMITHKLINE-US2023AMR040441:same reporter