Received Sep 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
Suspected vaccination failure; Shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. In AUG-2025, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown. 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: 27-AUG-2025 The reporter was the patient daughter. She stated that her mother received the Shingles vaccine in the past and she developed shingles 2 weeks ago. She reported that the rashes were still present. She did not know which shingles vaccines she received. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.