Received Aug 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; got shingles on my surgery leg; Stress; 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. The patient's past medical history included surgery. 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), shingles (Verbatim: got shingles on my surgery leg) and stress (Verbatim: Stress). The outcome of the vaccination failure, shingles and stress were not reported. It was unknown if the reporter considered the vaccination failure, shingles and stress to be related to Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles and stress to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 06-AUG-2025 This case was reported by a patient via interactive digital media. The patient had shingles shot before EAD perfected. The patient was under a lot of stress last year, got shingles on the surgery leg. It was reported as the patient caught one soar and right away went to doctor. The patient had only got 3 soars. The patient took medication and was fortunate. 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.
Medical History/Concurrent Conditions: Surgery