Received Apr 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
Suspected vaccination failure; Patient having an active case of shingles; The patient recived Shingrix vaccine 3 to 4 time per year; Prescribed Shingrix now while patient had active with shingles; This serious case was reported by a other health professional via other manufacturer and described the occurrence of vaccination failure in a 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), shingles (Verbatim: Patient having an active case of shingles), extra dose administered (Verbatim: The patient recived Shingrix vaccine 3 to 4 time per year) and drug prescribing error (Verbatim: Prescribed Shingrix now while patient had active with shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved and the outcome of the extra dose administered and drug prescribing error were not applicable. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 03-APR-2025 The patient received Shingrix vaccine 3 to 4 times per year and states that he was being prescribed this now while having an active case of shingles. The physician was unable to provide any further information and no other adverse events and product quality complaints. The patient received Shingrix vaccine 3 to 4 times per year which led to extra dose administered and prescribed Shingrix now while patient had active with shingles which led to drug prescribing error. 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.