Received May 20, 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; recently developed internal shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a adult female 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, several years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and zoster sine herpete (Verbatim: recently developed internal shingles). The outcome of the vaccination failure was not reported and the outcome of the zoster sine herpete was not resolved. It was unknown if the reporter considered the vaccination failure and zoster sine herpete 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 zoster sine herpete to be related to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 15-MAY-2025 The patient had the multi dose at some point in time but have recently developed internal shingles. The got both doses of Shingrix probably 7 or more years ago and was right now dealing with internal shingles. So the patient wanted to know if the efficacy of the vaccine ran out in that 7 or so years so should she get another round of Shingrix. The patient also wanted to know if a booster dose/third dose required with Shingrix. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding 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 laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (1st dose)and Shingrix(2nd dose).