Received Mar 17, 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 flares after receiving both vaccine doses; This serious case was reported by a other health professional via sales rep and described the occurrence of vaccination failure in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included type ii diabetes mellitus. On 17-JUL-2020, the patient received the 2nd dose of Shingrix. On 02-FEB-2020, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles flares after receiving both vaccine doses). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown. 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: 11-MAR-2025 The patient self-reported this case for himself. The patient had reported shingles flares after receiving both vaccine doses. The provider did not have documented an official shingles diagnoses. This case was considered as suspected vaccination failure as details regarding 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2).
Type II diabetes mellitus