Received Apr 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; have a very light case of it on a section of my thigh, with only 2 spots; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 68-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. In MAR-2025, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: have a very light case of it on a section of my thigh, with only 2 spots). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles 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 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. Patient reported about the Shingle shot. Patient stated that it would save a painful case of it down the road if ever got shingles. Patient got it at 60 and was 68 at the time of reporting and just the past 2 weeks from reporting patient had a very light case of it on a section of his/her thigh, with only 2 spots. Patient got on the anti-viral medications and the next day had nerve itching. Reporter stated if caught soon that helps a lot. 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: 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.