Received Apr 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; kept getting shingles; he could no longer walk; 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: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: kept getting shingles) and unable to walk (Verbatim: he could no longer walk). The outcome of the vaccination failure, shingles and unable to walk were not reported. It was unknown if the reporter considered the vaccination failure, shingles and unable to walk 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 unable to walk to be related to Shingles vaccine. Additional Information: GSK Receipt Date : 11-APR-2025 This case was reported by a consumer via interactive digital media. Reporter refused this dad got the shot for shingles and kept getting shingles and he got to where he needed wheel chair he could no longer walk and they called it something in muscles. So he/she will be refused. 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. This was 1 out of 3 linked cases, reported by same reporter different patient.; 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 Shingles vaccine. US-GSK-US2025AMR045181:same reporter /different patient US-GSK-US2025AMR045186:same reporter /different patient