Age: 76.0
Sex: F
Vaccine: COVID19, FLUX, VARZOS
Symptoms: Biopsy, Blood pressure increased, Blood pressure measurement, Echocardiogram, Granuloma
Clinical narrative: Elevated blood pressure; Granulomas on elbow, chest, abdomen, confirmed as benign; This non-serious case was reported by a consumer via call center representative and described the occurrence of granuloma in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis and COVID-19 VACCINE (COVID 19 VACCINE BOOSTER) for prophylaxis.   The patient's past medical history included mastectomy (prior double mastectomy).   On 22-JUN-2022, the patient received the 2nd dose of Shingrix (right arm). On an unknown date, the patient received Flu vaccine (right arm) and COVID 19 VACCINE BOOSTER (right arm). In JUL-2022, between 1 and 3 weeks after receiving Shingrix, an unknown time after receiving Flu vaccine and an unknown time after starting Cortison, the patient experienced granuloma (Verbatim: Granulomas on elbow, chest, abdomen, confirmed as benign). In JAN-2023, the patient experienced increased blood pressure (Verbatim: Elevated blood pressure). The patient was treated with cortisone (non-proprietary) (Cortison) and antifungals for topical use (Antifungal Cream). The outcome of the granuloma was not resolved and the outcome of the increased blood pressure was resolved.   It was unknown if the reporter considered the granuloma and increased blood pressure to be related to Shingrix and Flu vaccine.     It was unknown if the company considered the granuloma and increased blood pressure to be related to Shingrix and Flu vaccine.   Additional Information: GSK Receipt Date: 05-MAY-2023 The patient self-reported this case. The patient received flu vaccine and COVID booster around the time she received 2nd dose of Shingrix and stated that granuloma appeared just above the point of the right elbow around the beginning of July of 2022.  The granuloma got progressively bigger, as time passed.  The patient used fungal cream and cortisone on the spot, thought it was from a bug bite.  The patient saw dermatologist at the end of November/beginning of December of 2022, who diagnosed spot on elbow as a granuloma.  The dermatologist believed the granuloma was related to diabetes, but patient reported not being diagnosed with diabetes.  The patient reported experiencing elevated blood pressure in January of 2023, which resulted in pulmonologist ordering echocardiography and pet scan.  The patient reported granulomas in the chest and abdomen were discovered via the Pet scan.  The patient reported being referred to Oncologist, for biopsies of granulomas.  The patient reported granulomas were confirmed as benign.  The patient reported granulomas were simply present and did not bother them in any way.  The patient reported being uncertain of whether granulomas were related to receipt of Shingrix vaccine, but alleged they saw materials stating granulomas might be caused by vaccines. It was unknown if the company considered the granuloma and increased blood pressure to be related to COVID-19 VACCINE .  The reporter consented to follow up.