Received Apr 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
Suspected vaccination failure; come down with the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. In AUG-2024, the patient received the 2nd dose of Shingrix. In FEB-2024, the patient received the 1st dose of Shingrix. In MAR-2025, between 6 and 8 months after receiving Shingrix and between 1 and 2 years after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: come down with the shingles). 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 Shingrix and Shingrix. The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 24-MAR-2025 The case was received from the patient via (Shingrix GSK CHATBOT) interactive digital media. The patient had both Shingrix shots and in March of 25 he/she come down with the shingles. The patient was wondering when or if he/she should another shot. This case was considered as suspected vaccination failure as details regarding completion laboratory confirmation regarding shingles was 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 laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (1st dose)and Shingrix(2nd dose)