Received Nov 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | — |
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | — |
in the last year, started getting mild ones; stopped getting cold sores after I got your shingles shots in 2020; cold sores on my mouth; This non-serious case was reported by a consumer and described the occurrence of cold sore mouth in a 69-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included cold sores (used to get terrible cold sores on mouth that were triggered any time, when she ate citrus (lemon, orange) and took weeks to heal). Concurrent medical conditions included lung disorder (do have lung auto-immune problems from mico-bacteria (NTM)). On 02-FEB-2020, the patient received the 1st dose of Shingles vaccine. On an unknown date, the patient received the 2nd dose of Shingles vaccine. On 09-NOV-2025, 2107 days after receiving Shingles vaccine and more than 2 years after receiving Shingles vaccine, the patient experienced cold sore mouth (Verbatim: cold sores on my mouth). On an unknown date, the patient experienced cold sore mouth (Verbatim: in the last year, started getting mild ones) and unexpected therapeutic effect (Verbatim: stopped getting cold sores after I got your shingles shots in 2020). On 10-NOV-2025, the outcome of the cold sore mouth was resolved (duration 1 day). The outcome of the cold sore mouth was resolved and the outcome of the unexpected therapeutic effect was not applicable. It was unknown if the reporter considered the cold sore mouth and cold sore mouth to be related to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the cold sore mouth and cold sore mouth to be related to Shingles vaccine and Shingles vaccine. Additional Information: GSK Receipt Date: 13-NOV-2025 This contact was not for a side effect, but rather for an improvement. The patient stopped getting cold sores after she got shingles shots in 2020. However, in the last year (in 2024), she started getting mild ones and on 09-NOV-2025, got a significant one. The patient fears they were returning and felt like this vaccine could benefit anyone prone to severe cold sores which she understands were from herpesvirus. The patient would like to get a booster shot but not covered by her insurance. The patient asked that if you were doing any clinical trials for a 3rd shingles shot, she would like to be considered. The batch number was not provided and a request for this information has been made.
Lung disorder (do have lung auto-immune problems from mico-bacteria (NTM))
Medical History/Concurrent Conditions: Cold sores (used to get terrible cold sores on mouth that were triggered any time, when she ate citrus (lemon, orange) and took weeks to heal)