Received Aug 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | UNK | — |
Suspected vaccination failure; had it on my eye and 30 days from that, internal, and then on my head; Internal shingles; Shingles on head; 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), ophthalmic herpes zoster (Verbatim: had it on my eye and 30 days from that, internal, and then on my head) (serious criteria GSK medically significant), zoster sine herpete (Verbatim: Internal shingles) and shingles (Verbatim: Shingles on head). The outcome of the vaccination failure, ophthalmic herpes zoster, zoster sine herpete and shingles were not reported. The reporter considered the vaccination failure, ophthalmic herpes zoster, zoster sine herpete and shingles to be possibly related to Shingles vaccine. The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingles vaccine. The company considered the zoster sine herpete and shingles to be possibly related to Shingles vaccine. Additional Information: GSK Receipt Date: 20-AUG-2025 This case was reported by a patient via interactive digital media. The reporter reported that same had it on eye and 30 days from that, internal, and then on head. The reporter was also mentioned that the vaccination be triggered it. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming 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. A case of Ophthalmic herpes zoster, unknown time after receiving Shingles vaccine in a patient. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility.