Received Sep 3, 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; had two shots to prevent Shingles but I still got Shingles; This serious case was reported by a consumer and described the occurrence of vaccination failure in a patient who received Herpes zoster (Herpes Zoster vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Herpes Zoster vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Herpes Zoster vaccine and the 1st dose of Herpes Zoster vaccine. On an unknown date, an unknown time after receiving Herpes Zoster vaccine and Herpes Zoster vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had two shots to prevent Shingles but I still got Shingles). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Herpes Zoster vaccine and Herpes Zoster vaccine. The company considered the vaccination failure to be unrelated to Herpes Zoster vaccine and Herpes Zoster vaccine. It was unknown if the company considered the shingles to be related to Herpes Zoster vaccine and Herpes Zoster vaccine. Additional Information: GSK Receipt Date: 22-AUG-2025 This case was reported by a patient via interactive digital media. The have had two shots to prevent Shingles but still got Shingles. 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 completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles) is considered unrelated to GSK's Herpes Zoster vaccine (Dose 1 & 2).