Received Aug 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
had a case of shingles after getting Shingrix; had a case of shingles after getting Shingrix; 2nd dose in Oct 2022; This serious case was reported by a nurse via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. In OCT-2022, the patient received the 2nd dose of Shingrix. In FEB-2022, the patient received the 1st dose of Shingrix. In OCT-2022, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose in Oct 2022). On an unknown date, the patient experienced vaccination failure (Verbatim: had a case of shingles after getting Shingrix) (serious criteria GSK medically significant) and shingles (Verbatim: had a case of shingles after getting Shingrix). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the drug dose administration interval too long was not applicable. 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: 30-JUL-2025 The reporter stated that the patient experienced case of shingles after getting Shingrix. 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. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule. This case is one of the three linked cases reported by the same reporter.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix. US-GSK-US2025098394:same reporter, Different patient US-GSK-US2025098302:same reporter, Different patient