Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased, Hyperaesthesia, Immediate post-injection reaction, Inappropriate schedule of product administration, Laboratory test abnormal
Clinical narrative: cataracts have doubled in size; mole growth on the side of her face and under her breasts; dark patches with mole growth on the side of her face and under her breasts; tooth decay in her two top front teeth; skin has changed since receiving her second vaccine and has become more sensitive; elevated T4; diagnosis of diabetes; kidney problems; has a lump in her throat; purple rings around both her eye orbital areas that are in complete circles; loosing her eye sight in both eyes; had a weight loss of 20 pounds; Dry eyes; hearing loss in both ears with left ear hearing loss more significant; Tinnitus reported in both ears; burning sensation in her eyes; burning sensation in her tongue; burning sensation in her mouth; heart rate elevated and has been at an average rate of 149; loss of appetite; SHINGRIX dose 1 on 10/25/2022 and SHINGRIX dose 2 on 07/10/2023; This serious case was reported by a consumer via call center representative and described the occurrence of diabetes in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 25th October 2022). Concurrent medical conditions included cataract. Concomitant products included ophthalmologicals (nos) (Eye Drops (Ingredients Unknown)).   On 10-JUL-2023, the patient received the 2nd dose of Shingrix (right deltoid). On 10-JUL-2023, immediately after receiving Shingrix, the patient experienced heart rate increased (Verbatim: heart rate elevated and has been at an average rate of 149), appetite lost (Verbatim: loss of appetite) and drug dose administration interval too long (Verbatim: SHINGRIX dose 1 on 10/25/2022 and SHINGRIX dose 2 on 07/10/2023). On 13-JUL-2023, the patient experienced hearing loss bilateral (Verbatim: hearing loss in both ears with left ear hearing loss more significant) (serious criteria GSK medically significant), tinnitus (Verbatim: Tinnitus reported in both ears), burning sensation in eye (Verbatim: burning sensation in her eyes), burning tongue (Verbatim: burning sensation in her tongue) and burning oral sensation (Verbatim: burning sensation in her mouth). On 17-JUL-2023, the patient experienced eye dryness (Verbatim: Dry eyes). On 20-JUL-2023, the patient experienced weight loss (Verbatim: had a weight loss of 20 pounds). On 24-JUL-2023, the patient experienced unqualified visual loss, both eyes (Verbatim: loosing her eye sight in both eyes) (serious criteria GSK medically significant). On 31-JUL-2023, the patient experienced arcus senilis (Verbatim: purple rings around both her eye orbital areas that are in complete circles). On 16-OCT-2023, the patient experienced diabetes (Verbatim: diagnosis of diabetes) (serious criteria GSK medically significant), t4 increased (Verbatim: elevated T4), renal disorder (Verbatim: kidney problems) and lump feeling in throat (Verbatim: has a lump in her throat). On an unknown date, the patient experienced cataract aggravated (Verbatim: cataracts have doubled in size) (serious criteria GSK medically significant), mole of skin (Verbatim: mole growth on the side of her face and under her breasts), skin discoloration (Verbatim: dark patches with mole growth on the side of her face and under her breasts), tooth decay (Verbatim: tooth decay in her two top front teeth) and increased skin sensitivity (Verbatim: skin has changed since receiving her second vaccine and has become more sensitive). the patient experienced . The outcome of the diabetes, hearing loss bilateral, unqualified visual loss, both eyes, cataract aggravated, heart rate increased, t4 increased, weight loss, appetite lost, tinnitus, burning sensation in eye, burning tongue, burning oral sensation, eye dryness, arcus senilis, renal disorder, lump feeling in throat, mole of skin, skin discoloration and tooth decay were not resolved and the outcome of the increased skin sensitivity and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the diabetes, hearing loss bilateral, unqualified visual loss, both eyes, cataract aggravated, heart rate increased, t4 increased, weight loss, appetite lost, tinnitus, burning sensation in eye, burning tongue, burning oral sensation, eye dryness, arcus senilis, renal disorder, lump feeling in throat, mole of skin, skin discoloration, tooth decay and increased skin sensitivity to be related to Shingrix.     It was unknown if the company considered the diabetes, hearing loss bilateral, unqualified visual loss, both eyes, cataract aggravated, heart rate increased, t4 increased, weight loss, appetite lost, tinnitus, burning sensation in eye, burning tongue, burning oral sensation, eye dryness, arcus senilis, renal disorder, lump feeling in throat, mole of skin, skin discoloration, tooth decay and increased skin sensitivity to be related to Shingrix.   Additional Information: GSK receipt date: 20-Oct-2023 The patient immediately after receiving her 2nd Shingrix vaccine her heart rate elevated and had been at an average rate of 149. Less than a day after the vaccination, the patient experienced loss of appetite. 3 days after the vaccination, the patient had hearing loss in both ears with left ear hearing loss more significant, tinnitus. The reporter stated that her skin had changed since receiving her second vaccine and had become more sensitive to the point that she could not wear makeup and she had a burning sensation in her eyes, mouth, lips, and tongue. 7 days after the vaccination, the patient had both dry eyes and being treated with artificial tears eye drops.   10 days after the vaccination, the patient had a weight loss of 20 pounds.    14 days after the vaccination, she was loosing her eye sight in both eyes and had been to the eye doctor 4 times. 21 days after the vaccination, she had purple rings around both her eye orbital areas that were in complete circles. 98 days after the vaccination, abnormal lab results showed elevated T4 as well as kidney problems and a new diagnosis of diabetes.   The reporter reported that eye doctor told her that her cataracts had doubled in size in a short time.   The patient also developed dark patches with mole growth on the side of her face and under her breasts and had a lump in her throat that was not there before she received her 2nd Shingrix vaccine.   Reporter stated that after vaccine she developed tooth decay in her two top front teeth. During call husband was on the call and accompanied her report of all the above. The reporter consented to follow up. The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.