Received Apr 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | 54TF4 | — |
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | 54TF4 | — |
Suspected vaccination failure; Shingles on hip; This serious case was reported by a consumer and described the occurrence of vaccination failure in a 64-year-old female patient who received Herpes zoster (Shingles vaccine) (batch number 54TF4) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) (batch number 54TF4) for prophylaxis. Concurrent medical conditions included blood pressure high. On 26-MAY-2022, the patient received the 2nd dose of Shingles vaccine. On 24-MAR-2022, the patient received the 1st dose of Shingles vaccine. In JUN-2022, less than 2 months after receiving Shingles vaccine and between 2 and 4 months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles on hip). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved. It was unknown if the reporter considered the vaccination failure and shingles 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 to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 18-APR-2025 Consumer reported that she took two dose shingles vaccine and she get shingles 1 to 2x monthly on the hip area in JUNE 2022. This case was considered as suspected vaccination failure as details regarding laboratory test confirming 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 clinical description and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (Dose 1 & 2).
Blood pressure high