Age: 57.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Fatigue, Feeling abnormal, Flatulence, Headache, Hypothyroidism
Clinical narrative: Kidney function; hypothyroidism; Lipodermatosclerosis; messed up blood sugar level; muscle cramps; Anaemic; swelling of both ankles; lower leg, both legs are painful; inflammation of subcutaneous fat tissue; swelling of lower leg; gas; heartburn sensation; weird feeling on this; weak teeth; blood pressure; headache; feeling tired; WBC lowered; Fever; General body pain/ painful walk; This case was reported by a other health professional via other manufacturer and described the occurrence of renal function abnormal in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included ibrutinib (Imbruvica) for chronic lymphocytic leukemia.   The patient's past medical history included viral infection, burping, bloated feeling, allergy to vaccine, knee pain, heartburn, fever, chills, headache, stress, discomfort, diarrhea, gas, indigestion, vomiting, nodule on extremity, viral infection and swelling. Previously administered products included dry eyes. Concurrent medical conditions included type i diabetes mellitus and chronic lymphocytic leukemia. Concomitant products included allopurinol, valaciclovir hydrochloride (Valacyclovir), thyroxine sodium (Levothyroxine), lovastatin, levothyroxine, insulin lispro (Humalog) and magnesium.   On 16th August 2018, the patient received Shingrix. On 17th May 2018, the patient started Imbruvica (oral) 420 mg once daily (420 mg daily). In August 2018, less than a day after receiving Shingrix, the patient experienced tiredness and white blood cell decreased. On 16th August 2018, the patient experienced general body pain, fever and headache. On an unknown date, the patient experienced renal function abnormal (serious criteria GSK medically significant), hypothyroidism (serious criteria GSK medically significant), lipodermatosclerosis, blood sugar abnormal, muscle cramp, anemia, ankle swelling, leg pain, inflammation, swelling of legs, gas, heartburn, weird feeling, tooth disorder and increased blood pressure. The patient was treated with paracetamol (Tylenol), clobetasol propionate (Clobetasol), amoxicillin trihydrate (Amoxicillin) and lisinopril. The action taken with Imbruvica was unknown. On an unknown date, the outcome of the renal function abnormal, tiredness, blood sugar abnormal, white blood cell decreased, anemia, gas, heartburn, weird feeling, tooth disorder and increased blood pressure were unknown and the outcome of the hypothyroidism, general body pain, fever and headache were recovered/resolved and the outcome of the lipodermatosclerosis, muscle cramp, ankle swelling, leg pain and inflammation were not recovered/not resolved and the outcome of the swelling of legs was recovering/resolving.   It was unknown if the reporter considered the renal function abnormal, hypothyroidism, general body pain, lipodermatosclerosis, fever, headache, tiredness, blood sugar abnormal, muscle cramp, white blood cell decreased, anemia, inflammation, swelling of legs, gas, heartburn, weird feeling, tooth disorder and increased blood pressure to be related to Shingrix. The reporter considered the ankle swelling and leg pain to be possibly related to Shingrix.  Additional information reported as follows: On 4th June 2018, the patient received 420 mg of IMBRUVICA tablet, oral, daily. On unreported date, patient felt little stressed or uncomfortable in her stomach area like she has eaten to much like she need to burp. Patient had bloated like the feeling she has just before diarrhea or gas. The patient did not having either and her gas was not releasing.  On 5th June 2018, patient's knee started hurt a little bit and just hurt when she sits. Action taken with ibrutinib therapy was no change. The outcome of burp, bloated, like the feeling of having diarrhea or gas, knees hurt a little bit, just hurts when sitting and little stressed or uncomfortable in stomach was unknown. The patient did not provide the causality assessment between events burp, bloated, like the feeling of having diarrhea or gas, knees hurt a little bit, just hurts when sitting and little stressed or uncomfortable in stomach and ibrutinib.  On unknown date, patient was having dry eyes, slight indigestion and slight heartburn. Ibrutinib lowered her blood sugar a good bit. The patient did not have to use it as much insulin. The patient was having some diabetic lows, was on pump for insulin. Patient had heart tests on 18th June 2018 and to get a baseline of  heart in case she had issues arisen. Patient had a high potassium (exact values, units and normal ranges were not reported) so they tested again and patient did not hear results and this was the second time the test had not gone right. The outcome of high potassium, dry eyes and slight indigestion and slight heartburn was unknown. On 19th June 2018, patient noticed lymph node on right side of neck which began hurting. On 24th June 2018, she started having fever, chills and vomiting. Lymph nodes on her neck continued to hurt. The outcome of lymph node on neck hurting, vomiting, fever and chills was not recovered. The patient did not provide the causality assessment between the events lymph node on neck hurting, vomiting, fever, chills and ibrutinib.  The patient reported burp, bloated, like the feeling of having diarrhea or gas and knees hurt a little bit, just hurts when sitting. Patient mentioned that the final diagnosis for the event burp was heart burn and indigestion and final diagnosis for the event bloated, like the feeling of having diarrhea or gas was bloat. It was reported that there was no diagnosis for event knees hurt a little bit, just hurts when sitting.  Patient reported symptoms began at beginning of the treatment but have resolved with time. The patient was in the hospital from 25th June 2018 to 28th June 2018 due to a virus infection. She indicated having a spike of fever, vomiting and a lymph node on neck was painful for a week and half. She did not take ibrutinib dose on 26th June 2018 and on 27th June 2018. On 16th August, the patient received a shingles shot Shingrix. She had fever and pain after the shot (same day). The physician was instructed to take Tylenol. Paracetamol helped and it went away within 12 hours. She was having headache, body aches and her teeth were killing her which went away as well.  The outcome of fever, pain after the shot/body aches, teeth were killing, headache and fever was recovered. The patient had a bad reaction with a fever and feeling tired. She said this shingles shot messed up her blood sugar levels and it may caused her tiredness. She complained of muscle cramps on calvesat night occasionally and muscle cramps on fingers when holding things tight, like when driving and pushing a shopping cart. She reports WBC count went from 240,000 down to 182,000 (units and normal range not provided). Her lymph nodes were coming down. The patient was  anemic. Patient had occasional cramps in calves at night. On an unknown date, patient had swelling of both ankles for a couple of months. This was painful. Patient thought it was gout but uric acid levels were fine. Patient thought it was cellulitis but this was discarded.  The patient explained taking one week of amoxicillin, but this did not help. The patient had cramping. During delivery of new medication box, the patient might have missed one dose of ibrutinib but unsure.  The outcome of swelling of both ankles and cramping was not recovered. On an unknown date, patient was seeing a dermatologist for both lower legs, and was diagnosed with lipodermatosclerosis an inflammation of subcutaneous fat tissue. The right lower leg was worse than left lower leg, both legs are painful. As of last night, pain was constantly present. Patient stated that it was painful to walk. Dermatologist prescribed a steroid cream (clobetasol) and it has helped a little with swelling on lower legs. Patient said her endocrinologist disagrees with dermatologist's diagnosis and believe this issue with lower legs might be related to ibrutinib. The patient believed this was related to ibrutinib.  Patient had scheduled ultrasound to lower legs for a further evaluation on 11th October 2018. On unknown date, the patient had swelling in her wrist, hands, legs, lumps in legs, and pain in legs. The patient had a biopsy done but she was unable to pronounce the diagnosis. Patient had a steroid shot and has used steroid cream and it was much improved. Patient saw a dermatologist. Patient stated that a nurse encouraged her to have her dermatologist and oncologist communicate since her oncologist does not want her to continue the treatment that her dermatologist was doing.  It was reported that the patient had cramping and it was improved with stretching exercises. Patient said cramping was not as intense as before. Patient opened blister pack and places tablets in medicine box for convenience. On unknown date, patient experienced cramps, which did not go away despite stretching exercises. Laboratory test results and treatment details for the event were not reported. On 5th March 2019, the patient started 420 mg of IMBRUVICA tablet, oral, daily for the treatment of CLL.  On unreported date, the patient experienced gas. It was reported that, patient's cramping was not as bad and not as frequently as before. Patient was not having much cramping at night. Patient stated joining a health club and doing stretching exercises and believes there might be a correlation between stretching and less cramping and that times she feels cramping on hands, this may be when holding on the phone too long. Patient was having a heartburn sensation where throat and chest come together. Patient denies feeling pain, just a weird feeling on this area and having ice cream brings comfort to this area. Patient was being very busy and missed a dose of ibrutinib just once.  It was reported that the WBC count was not reducing as quickly as before. The patient stated her physician was not concerned about this. She gets blood work every six weeks. The patient reported feeling pretty much normal.  On an unknown date, patient experienced cramps in her hands and feet. She missed a couple of doses. On an unknown date, the patient was having blood work, results showed a downward trend, patient added that they were improving.  The patient was having had some scans, and everything was normal. The patient's laboratory results were not normal, but okay. On unknown date, the patient reported missed once or twice, kidney function a little less, weak teeth,  exhausted and blood pressure that goes up a little bit. The patient on blood pressure medication lisinopril. Patient's last blood work revealed results were a little up. Patient mentioned that her lab work numbers  were not normal, however results were within normal for the patient. Patient further stated that at  one point she was at 200,000, and then at 124, and once at 16. The patient was taking Lisinopril 0.5mg daily to protect the kidneys due to patient's diabetes condition. The patient's blood pressure was a little high but not high enough to control with medication. It was reported as patient reported having a little more cramping once in a while and she believes this cramping happens when not drinking enough water. Patient reported that when she drinks more water, there was less cramping. Patient also reported that her fingers feel cramped when holding a shopping cart too hard, or when holding the steering wheel too hard. She missed one dose of Imbruvica due to diabetic low. Patient explained that as diabetic, thr patient reported taking new blood pressure medication. Patient stated as diabetic, she protects her kidneys and by managing her blood pressure. Her blood pressure has been around the upper 130s and 140s, and doctor prescribed Lisinopril. After starting on Lisinopril, patient's blood pressure reading is around 126. Patient reported this happened like two months ago in June 2020. The patient reported that levothyroxine dosage was lowered to 125 mcg. Treatment medication included Lisinopril 10 mg daily and Levothyroxine 125 mcg. Laboratory test included as high blood pressure.