Received May 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
Suspected vaccination failure; Subclincal shingles; This serious case was reported by a consumer via sales rep and described the occurrence of vaccination failure in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and zoster sine herpete (Verbatim: Subclincal shingles). The outcome of the vaccination failure was not reported and the outcome of the zoster sine herpete was resolved. The reporter considered the vaccination failure and zoster sine herpete to be related to Shingrix. The company considered the vaccination failure and zoster sine herpete to be related to Shingrix. Additional Information: GSK Receipt Date: 12-MAY-2025 The reporter reported that patient received Shingrix vaccine and experienced subclincal shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and 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 completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.