Received Apr 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
suspected vaccination failure; lost sight in my right eye; throwup yellowstuff and had runs now I had them; lost sight in my right eye and right ear; it has took my life away from me; 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), loss of vision (Verbatim: lost sight in my right eye) (serious criteria GSK medically significant), shingles (Verbatim: throwup yellowstuff and had runs now I had them), ear disorder (Verbatim: lost sight in my right eye and right ear) and activities of daily living impaired (Verbatim: it has took my life away from me). The outcome of the vaccination failure and activities of daily living impaired were not reported and the outcome of the loss of vision and ear disorder were not resolved and the outcome of the shingles was resolved. It was unknown if the reporter considered the vaccination failure, loss of vision, shingles, ear disorder and activities of daily living impaired to be related to Shingles vaccine. The company considered the vaccination failure and loss of vision to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles, ear disorder and activities of daily living impaired to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 03-APR-2025 The case was received from the patient via interactive digital media. The patient was been told he/she need to get Shingles shots so he/she did and was so sick he/she did not know if make it home. The patient was throw up yellow stuff and had runs now, had them (shingles) for 5 years they had destroyed body as they never came out. He/she lost sight in my right eye and right ear plus spent a lot of money on physician, the patient stated he/she on medication for them. A few blisters would come out and go away for two years. The patient cannot go anywhere because mess herself/himself and did not know when it happened it just running yellow stuff it has took life away from he/she. 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 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 is an unlisted event which is considered unrelated to GSK Shingles vaccine. US-GSK-US2025AMR041581:Same reporter/ Diferent patient