Received May 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; lost my hearing in my right ear; went blind in my right eye; shingles; I throw up yellow stuff; I get knots all over my body; it hurts my nerves in my body; 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. 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), hearing loss unilateral (Verbatim: lost my hearing in my right ear) (serious criteria GSK medically significant), blind right eye (Verbatim: went blind in my right eye) (serious criteria GSK medically significant), shingles (Verbatim: shingles), vomiting (Verbatim: I throw up yellow stuff), nodule (Verbatim: I get knots all over my body) and post herpetic neuralgia (Verbatim: it hurts my nerves in my body). The outcome of the vaccination failure, hearing loss unilateral, blind right eye and vomiting were not reported and the outcome of the shingles, nodule and post herpetic neuralgia were not resolved. It was unknown if the reporter considered the vaccination failure, hearing loss unilateral, blind right eye, shingles, vomiting, nodule and post herpetic neuralgia to be related to Shingles vaccine. The company considered the vaccination failure, hearing loss unilateral and blind right eye to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles, vomiting, nodule and 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 had taken vaccine and thought he/she was going to die. Patient threw up yellow stuff, had run, and a high fever for three days. He/she came down with shingles, but they never appeared came out. He/she had been on medication for five years now. He/she had also nearly gone blind in his/her right eye and lost hearing in his/her right ear. Patient had developed knots all over his/her body and itching. The physician had said it was affecting the nerves in his/her body. He/she had felt like it was killing him/her from the inside out. 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. Blindness unilateral Deafness unilaterial are unlisted event which is considered unrelated to GSK Shingles vaccine.