Received Feb 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | — |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
Suspected vaccination failure; shingles; developed a rash on her right side yesterday; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 57-year-old female 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. In FEB-2022, the patient received the 1st dose of Shingrix. On 04-FEB-2025, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles) and itchy rash (Verbatim: developed a rash on her right side yesterday). The patient was treated with triamcinolone and valaciclovir. The outcome of the vaccination failure and itchy rash were not reported and the outcome of the shingles was unknown. It was unknown if the reporter considered the vaccination failure, shingles and itchy rash to be related to Shingrix and Shingrix. The company considered the vaccination failure, shingles and itchy rash to be unrelated to Shingrix and Shingrix. Additional Information: GSK Receipt Date: 05-FEB-2025 The patient who received 2 doses of Shingrix in 2022 and she thought she got her first dose in February 2022 and her second dose 6 months later. She developed a rash on her right side and one day before the reporting day that itches and went to the doctor. The doctor thought she had shingles and prescribed triamcinolone cream and valacyclovir. This case was considered as suspected vaccination failure as details regarding 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, and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix. Herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix. Rash pruritic is a listed event which, due to the following criteria (concurrent herpes zoster) is considered unrelated to GSK vaccine Shingrix.