Received Apr 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Organ failure; Suspected vaccination failure; developed shingles/still had the shingles scars on him; This serious case was reported by a consumer via interactive digital media and described the occurrence of organ 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, 1 year after receiving Shingles vaccine, the patient experienced organ failure (Verbatim: Organ failure) (serious criteria death), vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: developed shingles/still had the shingles scars on him). The outcome of the vaccination failure and shingles were not reported. The reported cause of death was organ failure. It was unknown if the reporter considered the organ failure, vaccination failure and shingles to be related to Shingles vaccine. The company considered the organ failure and vaccination failure 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: 18-APR-2025 This case was reported by a patient's wife via interactive digital media. The reporter stated that her late husband developed shingles less than a year after they both were vaccinated. He died of organ failure at about a year out. He still had the shingles scars on him. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Organ failure is an unlisted event which is considered unrelated to GSK Shingles vaccine. 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 and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.; Reported Cause(s) of Death: Organ failure