Received Apr 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; dealing with Ramsay Hunt Syndrome; Mine is on the left side of my face and head with ear involvement and blisters all around my eye; PHN right now; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included c-section, knee replacement and neck surgery (with titanium plates and screws). 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), ramsay-hunt syndrome (Verbatim: dealing with Ramsay Hunt Syndrome) (serious criteria GSK medically significant), shingles (Verbatim: Mine is on the left side of my face and head with ear involvement and blisters all around my eye) and post herpetic neuralgia (Verbatim: PHN right now). The outcome of the vaccination failure and shingles were not reported and the outcome of the ramsay-hunt syndrome and post herpetic neuralgia were not resolved. It was unknown if the reporter considered the vaccination failure, ramsay-hunt syndrome, shingles and post herpetic neuralgia to be related to Shingles vaccine. The company considered the vaccination failure and ramsay-hunt syndrome to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles and post herpetic neuralgia to be related to Shingles vaccine. Additional Information: GSK Receipt Date : 22-APR-2025 This case was reported by a patient via interactive digital media. The patient was dealing with Ramsay Hunt Syndrome and post herpetic neuralgia right now and she never experienced pain like this in her life. She had three children, one was a C-section, two total knee replacements, neck surgery with titanium plates and screws and more but none of it compared to the pain she had been experienced for two months. Her was on the left side of her face and head with ear involvement and blisters all around her eye. She got the vaccine but chemo treatments wiped out the vaccine. The reporter stated that to get vaccinated. 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. Herpes zoster oticus is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Medical History/Concurrent Conditions: C-section; Knee replacement; Neck surgery (with titanium plates and screws)