Sex: F
Vaccine: COVID19, FLUX, VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Oral herpes, Paraesthesia oral
Clinical narrative: Left upper lip cold sore; tingling sensation; she is outside the recommended time range of dose 2 administration stated in the PI.; This non-serious case was reported by a consumer via call center representative and described the occurrence of cold sores in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, INFLUENZA VACCINE for prophylaxis and COVID-19 VACCINE (COVID VACCINE) for prophylaxis.   The patient's past medical history included cold sores. Concurrent medical conditions included rheumatoid arthritis and crohn's disease.   On an unknown date, the patient received the 1st dose of Shingrix, did not receive the 2nd dose of Shingrix, INFLUENZA VACCINE and COVID VACCINE. On an unknown date, 2 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced cold sores (Verbatim: Left upper lip cold sore), tingling lips (Verbatim: tingling sensation) and incomplete course of vaccination (Verbatim: she is outside the recommended time range of dose 2 administration stated in the PI.).  The patient was treated with medication unknown (Over The Counter Cold Sore Treatment (Nos)). The outcome of the cold sores was resolved and the outcome of the tingling lips was resolved with sequelae and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the cold sores and tingling lips to be related to Shingrix.     It was unknown if the company considered the cold sores and tingling lips to be related to Shingrix.   Additional Information: GSK receipt date: 12-Sept-2023 The case was self-reported by the patient. The patient stated that she had cold sores in the past but not this severe. The patient reported that received her 1st dose of Shingrix approximately 10 months to 1 year ago also received a flu vaccine and a covid vaccine at the same time.     The patient developed a cold sore on her left upper lip 2 days after the flu vaccine and covid vaccine. Left upper lip cold sore was described as large covering half of the length of her upper lip (adverse event symptomatic). The patient also states that the cold sore was consistent for 2 months before healing and remains recurrent and had been using an over the counter cold sore medication.   The patient also reported a tingling sensation that was constant in the area of the upper left lip where the cold sore was located (adverse event symptomatic). The patient did not remember when the tingling started.   The patient also took biologic autoimmune suppressant. The patient's gynecologists' prescribed an unknown medication for the tingling sensation.   The patient was aware that she was outside the recommended time range of dose 2 administration stated in the package insert (inappropriate vaccine schedule). The patient could not remember her physician's last name. The reporter consented to follow-up. It was unknown if the reporter considered the cold sores and tingling lips to be related to flu vaccine covid vaccine. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.