Received Feb 6, 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; got shingles/shingles across my back, under my arm and across my chest; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 78-year-old female 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) and shingles (Verbatim: got shingles.shingles across my back, under my arm and across my chest). The patient was treated with valaciclovir hydrochloride (Valtrex). 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 Shingles vaccine and Shingles vaccine. It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 31-JAN-2025 The reporter requested that change the advertising because it is deceptive. The reporter was 78 year old woman who has had both shingles shots and got shingles. Needless to say, the reporter and everyone to know was led to believe, through they advertising that, if you got both shingles shots, you would not got shingles. At first, the reporter thought it was just her. But every one told, about 25 people, all asked if the reporter had gotten the shots because if so, the reporter would not get shingles. It turns out that, if they did get shingles, supposedly they get a milder case So the reporter been through a Valtrex prescription and shingles across the patient back, under arm and across chest. Just as it was done scabbing 4 weeks ago and after the worst pain the patient had ever had, it was starting up again in distinct places. The reporter requested to please change there false advertising that leaves people thinking they would not get. 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, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine(1st dose) and Shingles vaccine(2nd dose)