Received Apr 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; Ramsay Hunt Syndrome; PHN; 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 knee replacement (had two total knee replacements), neck surgery (had neck surgery with titanium plates and screws) and cesarean section (had three children, one was a C-section). 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: Ramsay Hunt Syndrome) (serious criteria GSK medically significant) and post herpetic neuralgia (Verbatim: PHN). The outcome of the vaccination failure was 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 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 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. Patient stated that she was dealing with Ramsay-hunt syndrome and PHN (post herpetic neuralgia) right now (at the time of reporting) and she had never experienced pain like this in her life. Patient indicated that 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 experiencing for two months. Patient stated that, in her case it was on the left side of her face and head with ear involvement and blisters all around her eye. Patient got the vaccine, but chemo treatments wiped out the vaccine, also she ask everyone to get vaccinated. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding Ramsay-hunt syndrome 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: Cesarean section (had three children, one was a C-section); Knee replacement (had two total knee replacements); Neck surgery (had neck surgery with titanium plates and screws)