Received Jun 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Urinary tract infection; Shingles; scars; shooting pain; terrible surface pain that a slight touch; Suspected Vaccination failure; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 75-year-old female 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), urinary tract infection (Verbatim: Urinary tract infection) (serious criteria hospitalization), shingles (Verbatim: Shingles), scar (Verbatim: scars), shooting pain (Verbatim: shooting pain) and allodynia (Verbatim: terrible surface pain that a slight touch). The outcome of the vaccination failure, urinary tract infection, shingles and scar were not reported and the outcome of the shooting pain and allodynia were not resolved. It was unknown if the reporter considered the vaccination failure, urinary tract infection, shingles, scar, shooting pain and allodynia to be related to Shingles vaccine. The company considered the vaccination failure and urinary tract infection to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles, scar, shooting pain and allodynia to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 07-JUN-2025 The patient had the vaccines, and still had shingles, on top of a major urinary tract infection that put in the hospital a year and a half ago at the age of 75. On top of scars, the patient was continued to have terrible surface pain that a slight touch, even by her bra, sends shooting pain through her. 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 the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Urinary tract infection is an unlisted event which is considered unrelated to GSK Shingles vaccine.