Received Apr 15, 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 | — |
Completed shingles immunization series in 2022, was diagnosed with shingles last week/ suspected vaccination failure; Completed shingles immunization series in 2022, was diagnosed with shingles last week; This serious case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a 65-year-old male 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: Completed shingles immunization series in 2022, was diagnosed with shingles last week/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Completed shingles immunization series in 2022, was diagnosed with shingles last week). The patient was treated with prednisone and valaciclovir (Valacyclovir). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved. 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. The company considered the shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK receipt date: 07-APR-2025 The patient completed shingles immunization series in 2022, was diagnosed with shingles last week. Male patient 65 years old showed up with rash on left arm, blisters and pain. The patient was treated with prednisone and valacyclovir due to suspected case of 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 clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 & 2).