Received Aug 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
Suspected vaccination failure; shingles; disrupted my whole nervous system; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles) and nervous system disorder (Verbatim: disrupted my whole nervous system). The outcome of the vaccination failure and shingles were not reported and the outcome of the nervous system disorder was not resolved. The reporter considered the vaccination failure, shingles and nervous system disorder to be possibly related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. The company considered the shingles and nervous system disorder to be possibly related to Shingrix. Additional Information: GSK Receipt Date: 14-AUG-2025 This case was reported by a patient via interactive digital media. The patient mentioned that (Shingrix) shingles vaccine actually gave them shingles and has now disrupted whole nervous system. 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 vaccine Shingrix.