Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; Shingles; Scars; 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, 3 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and scar (Verbatim: Scars). The outcome of the vaccination failure and shingles were not reported and the outcome of the scar was not resolved. It was unknown if the reporter considered the vaccination failure, shingles and scar 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 scar to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 25-FEB-2025 This case was reported by a patient via interactive digital media. The patient had been vaccinated three years before he/she got shingles, was not diagnosed by medical people for five days because it could not be shingles. The patient had excruciating pain, the blisters was awful. The patient still had the scars. When the patient asked if he/she should get vaccinated again they said no, only once was necessary and further he/she stated you were susceptible to getting shingles again. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule 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 the clinical description, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.