Received Apr 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected Vaccination failure; bad cases of shingles inside his ear; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male 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) and herpes zoster otitis externa (Verbatim: bad cases of shingles inside his ear) (serious criteria GSK medically significant). The outcome of the vaccination failure and herpes zoster otitis externa were not reported. It was unknown if the reporter considered the vaccination failure and herpes zoster otitis externa to be related to Shingles vaccine. The company considered the vaccination failure and herpes zoster otitis externa to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 16-APR-2025 This case was reported by a consumer via interactive digital media. The reporter know friend vaccinated and still had bad cases of shingles. He had them inside his ear. 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. This case is linked with US2025AMR046801, reported by same reporter.; 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. Herpes zoster oticus is an unlisted event which is considered unrelated to GSK Shingles vaccine. US-GSK-US2025AMR046801:same reporter different patient