Received Mar 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 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 patient who received Herpes zoster (Shingrix) for prophylaxis. In OCT-2024, the patient received Shingrix. In DEC-2024, less than 2 months after receiving Shingrix, 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 not resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure and shingles to be unrelated to Shingrix. Additional Information: GSK Receipt Date: 19-FEB-2025 The patient had been dealing with shingles since middle of December 2024 and still had unbelievable itching ,pain constantly. The patient had tried everything and nothing has helped. The patient asked for suggestions that can help and this was after the vaccine in October. The patient was wondering how this help seemed not to have helped. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination 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 the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix. Herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix.