Received Aug 25, 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; Shingles; was out of work; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, 2 months after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and impaired work ability (Verbatim: was out of work). The patient was treated with gabapentin. The outcome of the vaccination failure and shingles were not reported and the outcome of the impaired work ability was resolved (duration 5 days). It was unknown if the reporter considered the vaccination failure, shingles and impaired work ability 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 and impaired work ability to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 10-AUG-2025 This case was reported by a patient's wife via interactive digital media. The reporter and the patient received both injections of the vaccine and two months later had shingles. The patient was out of work 5 days. The doctor prescribed gabapentin and something else. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting. This case is linked with case US2025AMR104472 from the same reporter for herself.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, medical history, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (dose 1) and Shingrix (dose 2).