Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Pain in extremity, Renal impairment, Vision blurred
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of kidney dysfunction in a 65-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included systemic lupus erythematosus. On 1st May 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 1st May 2019, less than a day after receiving SHINGRIX, the patient experienced pain in arm. In May 2019, the patient experienced kidney dysfunction (serious criteria GSK medically significant), kidney infection (serious criteria GSK medically significant), migraine, muscle pain, nerve pain, joint pain, blurred vision and burning sensation. The patient was treated with antibiotics nos and diuretics nos (Diuretics). On 9th May 2019, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the kidney dysfunction, migraine, muscle pain, nerve pain and joint pain were not recovered/not resolved and the outcome of the kidney infection, blurred vision and burning sensation were unknown. It was unknown if the reporter considered the kidney dysfunction, kidney infection, migraine, muscle pain, nerve pain, joint pain, pain in arm, blurred vision and burning sensation to be related to SHINGRIX. Additional details were provided as follows: The patient herself was the registered nurse. The patient received the vaccine in left arm. The patient complained SHINGRIX vaccine attacked every system in her body due to an unknown ingredient in SHINGRIX that ramps up immune responses. Less than a month after receiving SHINGRIX, the patient's reaction started out with migraines followed by muscle aches followed by nerve pain and ended with attacking her kidneys. The patient reported of taking undisclosed medication for daily migraines despite much relief. The reporter stated high level of pain described as affecting every large nerve in her body, joint pain, muscle pain, and blurry vision. The patient described her nerves as aching, burning, and on fire (like when people come down with shingles). The patient reported her left arm being sore for approximately 8 days. The patient's kidneys were shutting down due to not passing urine for a few days and urine building up in abdomen. The patient was almost going to the emergency room prior to taking undisclosed diuretics and urinating 6 pounds. The kidneys began to work again, but ended up with a kidney infection in the midst of everything and had to take undisclosed antibiotics. Lastly, the patient reported that, she felt as if she just started to come out of this within the past 24 hours before the date of reporting, but was still not fully recovered. The patient described reaction as an absolute nightmare. The patient could take 2nd shot, and inquires what information was available as far as the efficacy of 1 dose. As due to having lupus the patient did not want to be administered vaccines that may ramp up her immune system and did not wanted to be used as a lab rat based on ingredient that ramps up system. The patient desired to receive SHINGRIX vaccine due to her mother had shingles twice and was in much severe pain not relieved by morphine leaving scars along rib cage from shingles. The patient was not getting 2 dose. She mentioned she might get older shot (ZOSTAVAX) again. Has already talked to the FDA. The reporter consented to follow up.