Received Apr 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
neuropathy; Fibromyalgia; COVID-19; Shingles; Suspeceted vaccination failure; 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 mastectomy (right mastectomy), surgery and illness. Concurrent medical conditions included cancer (stage 4 cancer) and decreased immune responsiveness. On an unknown date, the patient received Shingles vaccine. In SEP-2024, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). On an unknown date, the patient experienced neuropathy (Verbatim: neuropathy) (serious criteria GSK medically significant), fibromyalgia (Verbatim: Fibromyalgia) and covid-19 (Verbatim: COVID-19). The outcome of the vaccination failure, neuropathy, shingles, fibromyalgia and covid-19 were not reported. It was unknown if the reporter considered the vaccination failure, neuropathy, shingles, fibromyalgia and covid-19 to be related to Shingles vaccine. The company considered the vaccination failure, neuropathy, shingles, fibromyalgia and covid-19 to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 28-MAR-2025 This case was reported by a patient via interactive digital media. The patient had the Shingles vaccine years ago and right after stage 4 cancer and her right mastectomy was healing, her immune system was weak, and shingles down her back, right arm and in her new mastectomy scar. The patient got neuropathy and fibromyalgia from damaged nerves and chemo, the patient had a lot of surgeries and illnesses the patient believed shingles were probably one of the worst pains patient ever had. The reporter stated that if you had the vaccine and your immune system was way low like them then you could get anything. The patient spent 10 days in isolation for covid and the next day shingles and in isolation another 9 days total of 19 days in isolation. That was last September. This case was considered as suspected vaccination failure as details regarding completion of primary 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 time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine Herpes zoster, Neuropathy peripheral, Fibromyalgia, and COVID-19 are unlisted events which are considered unrelated to GSK Shingles vaccine."
Cancer (stage 4 cancer)
Medical History/Concurrent Conditions: Decreased immune responsiveness; Illness; Mastectomy (right mastectomy); Surgery