Received Dec 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | — |
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | — |
Suspected vaccination failure; I think maybe the virus was hiding there; after the second shot a perfectly round, red spot showed up on the top of my right hand; after the second shot a perfectly round swollen spot showed up on the top of my right hand; 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. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I think maybe the virus was hiding there), red hands (Verbatim: after the second shot a perfectly round, red spot showed up on the top of my right hand) and hand swelling (Verbatim: after the second shot a perfectly round swollen spot showed up on the top of my right hand). The outcome of the vaccination failure, shingles, red hands and hand swelling were not reported. It was unknown if the reporter considered the vaccination failure, shingles, red hands and hand swelling to be related to Shingles vaccine and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles, red hands and hand swelling to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 26-NOV-2025 This case was reported by a patient via interactive digital media. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The batch number was not provided, and unable to contact the reporter.; Sender's Comments: A case of Vaccination failure, on an unknown time after receiving 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine, in a patient. Causal association is indeterminate. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received