Received Jul 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | — |
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | — |
Suspected Vaccination failure; mild case of shingles for the 2nd time on my thigh/have shingles now/headache and fatigue; nausea; diarrhea; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 65-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: mild case of shingles for the 2nd time on my thigh/have shingles now/headache and fatigue), nausea (Verbatim: nausea) and diarrhea (Verbatim: diarrhea). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved and the outcome of the nausea and diarrhea were resolved. It was unknown if the reporter considered the vaccination failure, shingles, nausea and diarrhea to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles, nausea and diarrhea to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 21-JUL-2025 and 22-JUL-2025 This case was reported by a patient via interactive digital media. The patient had two Shingles shots and have shingles now and the patient got it last year in 2024. The patient stated that it was a mild case of the shingles for the 2nd time on his/her right outer thigh. The worse part was the nausea, diarrhea, headache and fatigue and lasted a couple days. This case was considered as suspected vaccination failure since the details regarding the 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 time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2).