Received Jul 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; vertigo so bad I passed out; Oral shingles; Vertigo; I get sick or stressed I break out again; I get sick or stressed I break out again; 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), passed out (Verbatim: vertigo so bad I passed out) (serious criteria GSK medically significant), oral herpes zoster (Verbatim: Oral shingles), vertigo (Verbatim: Vertigo), sickness (Verbatim: I get sick or stressed I break out again) and stress (Verbatim: I get sick or stressed I break out again). The outcome of the vaccination failure, passed out, oral herpes zoster, sickness and stress were not reported and the outcome of the vertigo was not resolved. It was unknown if the reporter considered the vaccination failure, passed out, oral herpes zoster, vertigo, sickness and stress to be related to Shingles vaccine. The company considered the vaccination failure and passed out to be unrelated to Shingles vaccine. It was unknown if the company considered the oral herpes zoster, vertigo, sickness and stress to be related to Shingles vaccine. Additional Information: GSK receipt date: 21-JUL-2025 This case was reported by a patient via interactive digital media. The patient had the shingle shot, it gave patient oral shingles and vertigo so bad that he/she passed out. 2 years later, the patient still had vertigo issues and when they get sick or stressed it break out again. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding oral 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. Loss of consciousness is an unlisted event which is considered unrelated to GSK Shingles vaccine.