Received Apr 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; neuropathy; still got shingles; use a walker; 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: Suspected vaccination failure) (serious criteria GSK medically significant), neuropathy (Verbatim: neuropathy) (serious criteria GSK medically significant), shingles (Verbatim: still got shingles) and walker user (Verbatim: use a walker). The outcome of the vaccination failure, neuropathy, shingles and walker user were not reported. It was unknown if the reporter considered the vaccination failure, neuropathy, shingles and walker user to be related to Shingles vaccine. The company considered the vaccination failure and neuropathy to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles and walker user to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 05-APR-2025 This case was reported by a patient via interactive digital media. The patient had the shots a number of years ago. Thought he/she was covered. Still got the shingles. The patient was expecting the rash but did not know neuropathy could also be a problem. Six months later having to use a walker because there was no feeling on right side from the waist down. Was told that the vaccine was gotten years ago has been replaced by a better product. Planning to get it when doctor says it was time. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming 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 time to onset for shingles, completion of primary vaccination schedule and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingles vaccine. Neuropathy peripheral is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine.