Received Aug 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
had two outbreaks of shingles since then and one in July; Suspected vaccination failure; had two outbreaks of shingles since then One in March; 39 years patient received Shingrix; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 39-year-old patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included renal disease. In DEC-2024, the patient received Shingrix. In DEC-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 39 years patient received Shingrix). In MAR-2025, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had two outbreaks of shingles since then One in March). In JUL-2025, the patient experienced shingles (Verbatim: had two outbreaks of shingles since then and one in July). The outcome of the vaccination failure, shingles and shingles were not reported and the outcome of the inappropriate age at vaccine administration was not applicable. It was unknown if the reporter considered the vaccination failure, shingles 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 and shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 21-JUL-2025 The patient received the Shingrix vaccine in December and had two outbreaks of shingles since then which was one in March and one in July. The patient was very disappointed. The patient thought it was supposed to prevent future outbreaks and had to go on medication for them and was not supposed to take it because of his/her kidney disease. The patient received a dose of Shingrix at an inappropriate age, which led to inappropriate age at vaccine administration. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of 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 and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.
Renal disease