Received Apr 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; Ramsey Hunt Syndrome / Shingles on left side ear; 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) and ramsay-hunt syndrome (Verbatim: Ramsey Hunt Syndrome / Shingles on left side ear) (serious criteria GSK medically significant). The outcome of the vaccination failure and ramsay-hunt syndrome were not reported. It was unknown if the reporter considered the vaccination failure and ramsay-hunt syndrome to be related to Shingles vaccine. The company considered the vaccination failure and ramsay-hunt syndrome to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 19-APR-2025 The patient had all the shingles vaccines and recently diagnosed with Bell's palsy and later found out it was Ramsey Hunt Syndrome. The patient had shingles on left side ear. It was very painful. 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. Herpes zoster oticus is an unlisted event which is considered unrelated to GSK Shingles vaccine.