Received Aug 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected Vaccination failure; I had shingles before or after I got the vaccine/Luckily mine was on the front towards the waist,; I do remember how hard it was to sleep; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I had shingles before or after I got the vaccine/Luckily mine was on the front towards the waist,) and difficulty sleeping (Verbatim: I do remember how hard it was to sleep). The outcome of the vaccination failure, shingles and difficulty sleeping were not reported. It was unknown if the reporter considered the vaccination failure, shingles and difficulty sleeping to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles and difficulty sleeping to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 27-JUL-2025 This case was reported by a patient via interactive digital media. Reporter reported that he/she was prayed that it would go away. He/she could not even remember whether he/she had shingles before or after the vaccine, but he/she did remember how hard it was to sleep and not scratch. Luckily mine was on the front towards the waist, so at least he/she could lie on back and try to be still, to sleep. Good luck to you and hope many people pray for you. If you have not had the shingles shot, ask your doctor whether you should get it now. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, 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 Shingles vaccine.