Received Jun 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
she began breaking out with cold sores on her mouth/lips; This non-serious case was reported by a consumer via call center representative and described the occurrence of cold sores in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose on an unknown date). Concurrent medical conditions included arthritis and hypertension. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 3 months after receiving Shingrix, the patient experienced cold sores (Verbatim: she began breaking out with cold sores on her mouth/lips). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the cold sores was not resolved. It was unknown if the reporter considered the cold sores to be related to Shingrix. It was unknown if the company considered the cold sores to be related to Shingrix. Additional Information: GSK Receipt Date: 04-JUN-2025 The reporter reported that a patient received both doses of Shingrix vaccine and approximately 3 months later she began breaking out with cold sores on her mouth/lips. The consumer states she has had approximately 2 or 3 outbreaks per year for the last few years. Consumer states she is being treated for the outbreaks and was prescribed Valtrex to be taken at onset of cold sore. No further information was obtained/provided.
Arthritis; Hypertension