Received Apr 15, 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; surgery for a fractured wrist; shingles; Inappropriate schedule of vaccine administered; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix and 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), wrist surgery (Verbatim: surgery for a fractured wrist) (serious criteria clinically significant/intervention required), shingles (Verbatim: shingles) and drug dose administration interval too long (Verbatim: Inappropriate schedule of vaccine administered). The outcome of the vaccination failure and wrist surgery were not reported and the outcome of the shingles was not resolved and the outcome of the drug dose administration interval too long was not applicable. It was unknown if the reporter considered the vaccination failure, wrist surgery and shingles to be related to Shingrix and Shingrix. The company considered the vaccination failure and wrist surgery 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: 07-APR-2025 The reporter reported that patient need some guidance on if he/she could take a second set of shots. Patient was vaccinated with Shingrix in 2021. His/her second dose was 6 months after the first one. This was in 2021. Patient had 2 cases of Shingles since then. One was happening now. Patient asked, what should a patient do if their second dose of Shingrix was later than six months after receiving the first dose. He/she did the series of Shingrix. His/her second shot was 6 most after the first. Patient had 2 cases of Shingles since then. One after surgery for a fractured wrist, and the second case started a few days ago. Patient was wondering what the research says about getting a second series of shots. But here he/she with 2 cases of shingles after having the shots. The second shot was 7 months after the first. It was in 2021 during covid time. Patient asked that would had the shot again be an option for him/her. 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) and Shingrix (dose 2). Wrist surgery is an unlisted event which is considered unrelated to GSK vaccine Shingrix (dose 1) and Shingrix (dose 2).