Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Sepsis, Swelling, Weight, Weight decreased
Clinical narrative: SEPSIS; ANEMIA; BUMPS AND ITCHY SPOTS ON SKIN; ELEVATED IGM/ IGM HAS DOUBLED; ELEVATED BUN; HIGH RED CELL DISTRIBUTION WIDTH; ELEVATED CREATININE; SWELLING; BILATERAL FEET EDEMA; LOSING WEIGHT; RIGHT FOOT REDNESS; ITCHY SKIN; HEMOGLOBIN LOW; DIFFICULTY WALKING/ COULD BARLEY WALK/ HAD TO CRAWL TO BATHROOM; DISCOMFORT OF FEET; LEFT FOOT/ RIGHT HAND/ PAIN IN BOTTOM OF FEET; FALL; GOUT LIKE SYMPTOMS/ GOUT IN FEETS/ POSSIBLE GOUT; This spontaneous report received from a patient by a Business partner on 22-NOV-2021 concerned an 82 year old male. The patient's weight was 136 pounds, and height was 64 inches. The patient's past medical history included: mastoid surgery, tonsillitis, tonsillectomy, right foot surgery, kidney stone, inguinal hernia, cataract surgery, and right hip surgery, and concurrent conditions included: alcohol use, hemorrhoids, chronic kidney disease, no tobacco, sulfa drugs allergy, chronic kidney disease, allergic to IVP dye, waldenstrom macroglobulinemia, leafy green allergy and internal bleeding. The patient was previously treated with colchicine for gout like symptoms or gout in feet or possible gout, methylprednisolone for gout like symptoms or gout in feet or possible gout, sulfadiazine silver, fluocinonide, triamcinolone acetonide, ammonium lactate, and cyanocobalamin for supplement; and experienced drug allergy when treated with cefadroxil, dexamethasone, metronidazole, alendronate sodium, glycopyrronium bromide, and levofloxacin. The patient received ibrutinib (capsule, oral, batch number was not reported) dose and frequency were not reported from 15-MAY-2015 for waldenstrom macroglobulinemia; and ibrutinib (tablet, oral, batch number was not reported) dose, frequency, and therapy dates were not reported for waldenstrom's macroglobulinemia. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, 1 total, administered on 23-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date in MAY-2021, patient experienced gout like symptoms or gout in left and right feet, right foot was worse. The Gout was painful and caused swelling. The patient had anemia and it improved. The IgM level at oit was lowest, but still elevated. BUN and Creatinine level was elevated. On an unspecified date, patient was hospitalized due to sepsis but did not remembered when the event occurred. Patient had difficulty in walking and had pain in his feet which started in MAY 2021. He had a fall while he went to bathroom. Patient described that right foot was always worst compared to the left during the days when he had the Swelling and Discomfort. Patient reported that physician was treating him for gout but the physician was not entirely sure that it was gout. He was receiving prednisone and allopurinol with little effect. He had bilateral feet edema where his right foot was red and swollen but left foot is more swollen with pain. He had right hand pain that was similar to gout but physician was unsure. He had bumps and itchy spots on skin. He was losing weight. He had gout in his feet and causing it to be difficult to walk. His gout was improving and the health care professional was weaning him off of allopurinol. His medication caused him gout. Patient could barely walk. He had pain in his bottom of feet and he had to crawl to bathroom sometimes due to pain in his foot. Number of days of hospitalization was not reported. The patient received ibrutinib (capsule, oral, batch number was not reported) 420 mg, 1 time every 1 day, from 15-MAY-2015, and 420 mg, 1 time every 1 day, therapy dates were not reported for waldenstrom macroglobulinemia.  Laboratory data (dates unspecified) included: BUN (NR: not provided) Elevated BUN, Creatinine (NR: not provided) Elevated creatinine, Hemoglobin (NR: not provided) Low, IgM (NR: not provided) Elevated, Red cell distribution width (NR: not provided) High, and Weight (NR: not provided) Weight loss. Treatment medications (dates unspecified) included: allopurinol, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with ibrutinib was not changed. The patient recovered from difficulty walking/ could barley walk/ had to crawl to bathroom on 2021, and left foot/ right hand/ pain in bottom of feet, was recovering from anemia, gout like symptoms/ gout in feets/ possible gout, discomfort of feet, bumps and itchy spots on skin, and itchy skin, had not recovered from elevated IGM/ IGM has doubled, fall, swelling, bilateral feet edema, losing weight, and right foot redness, and the outcome of sepsis, elevated bun, high red cell distribution width, elevated creatinine and hemoglobin low was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This case, involving the same patient is linked to 20210710661.; Sender's Comments: V0: 20211150392-COVID-19 VACCINE AD26.COV2.S- Sepsis, anemia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20211150392-IBRUTINIB- Sepsis, anemia. This event(s) is labeled per Agency and is therefore considered potentially related.