This case reported by a physician via other manufacturer and described the occurrence of swelling in a 78-year-old female patient who received FLUARIX. The patient's past medical history included fibromyalgia, osteoporosis, degenerative joint disease, renal cyst, cholecystitis, Crohn's disease, total abdominal hysterectomy with bilateral salpingo-oophorectomy (status post TAH/BSO in 1964), appendectomy (at age 15) intestinal obstruction (bowel obstruction 2 times requiring intestinal resection in 1986), intestinal resection, open reduction of fracture with internal fixation (post left ankle ORIF), infected finger (fifth finger infection requiring insertion of a pin), tonsillectomy, cholecystectomy, rib excision (removal of the right first rib), cataract extraction (with intraocular lens implantation bilaterally), intraocular lens implant (cataract extraction with intraocular lens implantation bilaterally), colonoscopy, tobacco user and post menopause. Concomitant products included ARIMIDEX, Calcium, Hydrocodone/Acetaminophen, IMODIUM, Potassium Chloride Elixir, LIDODERM, LOMOTIL, meloxicam, NEXIUM, VALIUM and cyanocobalamin. On an unknown date, the patient received FLUARIX at an unknown dose. On an unknown date, unknown after receiving FLUARIX, the patient experienced swelling. On an unknown date, the outcome of the swelling was unknown. It was unknown if the reporter considered the swelling to be related to FLUARIX. Additional details were reported as follows: The age at vaccination was not reported. The patient was 78 year old female with a history of right sided breast cancer(diagnosed on 1st October 2014, stage IV (Tx Nx M1) ER plus, pr plus , HER-2 per NEU with bone metastases and pulmonary metastases status post tamoxifen, bone metastases, osteoporosis and Crohn disease, here for follow up. On 9th August 2017, the patient had been doing okay since her last visit. She still has more energy than last time. The Crohn's flare-ups have decreased a little bit. She denied any other new complains or issues. The patient's past medical history was possible osseous neoplastic process, diagnosed on 13th November 2013 by lumbar spine MRI. The social history positive tobacco, no alcohol and no drugs. The family history was the patient's mother had melanoma, sister had breast cancer and another sister had an unknown malignancy. The review of systems was reported as follow: The general review was no chills, weight loss, weight gain or night sweats. For skin no rash or jaundice. For heentHEENT, excessive tearing or headaches. For Neck no dysphagia, lumps or bumps. For Heme or lymph no easy bruising,easy bleeding. For respiratory system no Shortness or breath or cough. For cardiovascular, no chest pain, palpitations, or dyspnea on exertion. For gastrointestinal, negative for loose stools, no nausea, vomiting, melena, bright red blood per rectum, constipation or abdominal pain. For genitourinary, no dysuria or hematuria. For endocrine, no heat intolerance or cold intolerance. For musculoskeletal, no myalgia or arthralgia. No back pain. For neurological, no syncope or seizures. In the physical examination vitals reviewed, ECOG performance status was one. For general oriented 3 times, not in distress. For HEENT, EOMI, PERRLA, oropharynx patent no masses. For neck, supple, no JVD. For lunges were clear. Heart, regular rate and rhythm,s1-s2 normal, no murmurs, rubs or gallops. For abdomen, soft, mild tenderness, distention or masses. No hepatosplenomegaly. For musculoskeletal, no edema. For neurological, cranial nerves II-XII intact, no sensory or motor deficits, muscle strength 5/5 in all four extremities. For lymph nodes, no cervical adenopathy no supraclavicular adenopathy, not axillary adenopathy. For psych, affect appropriate, cognitively intact skin, adequate turgor2 no lesions present. The laboratory and imaging studies was reviewed. The assessment was right sided breast cancer, stage IV (Tx Nx M1) status post tamoxifen with progressions, fibromyalgia, osteoporosis, degenerative joint disease, Crohn disease, bone metastases, clostridium difficile infection, treated, back pain, dehydration and anemia. The plan was, the patient had previously progressed on tamoxifen. She did not tolerate AROMASIN, so she was put on ARIMIDEX. PET scan in January 2017 showed disease progression, so we switched her to IBRANCE plus fulvestrant, which she was tolerating. She has had a good response on Imaging as well. Continue with IBRANCE and fulvestrant. Continue IV iron due to significant iron deficiency secondary to Crohn's. Continue XGEVA for bone mets. Repeat PET scan in November 2017 the patient was return to clinic in four weeks with repeat labs. The line of therapy of breast cancer was 1st line. The current status was evidence of metastatic disease. Carcinoma of unknown primary tumor date of diagnosis was 10th Jan 2014, Iron deficiency anemia Health maintenance was reported below: Preventative care and screening. Tobacco history: current every day smoker, started smoking 45 years ago smoked no more than 2 pics per day was down to 1pk per day now patient states. Pneumonia vaccine status and shingles vaccine status was never. The colon cancer screening the date of last colonoscopy in 2012. Last mammogram done on 9th Jan 2014. Last DEXA scan was on Jan 2014. Last pap smear was in 2004 and last pelvic exam was in 2004. Obstetrics and gynecology history was reported. The menopausal status was postmenopausal. The vital signs was height: 65 in, weight: 111lbs, pain care plan: no pain reported, blood pressure:115/72 pulse: 88 bpm, respiration: 16 rpm, temperature: 97.8 deg F, O2 Sat: 98 percentage, at rest,(O1O), Current O, BMI 18.47 kg/m2, Underweight, BMI: 17.97 kg/m2, Underweight, Karnofsky performance status: 100% Normal, no complaints; no evidence of disease. Laboratory was performed. C8C:WBC was 5.4, RBC: 3.20, NRBC absolut: 0.0, NRBC percentage: 0.0, HGB: 10.4, HCT:31.5, MCV:98.4, MCH: 32.5,MCHC:33.0,RDW:23.9,PLT:367,MPV:8.4, Neu percentage:85.4, LY percentage 10.5, MO percentage 2.8, EO percentage: 0.0, BA percentage: 0.7, IG percentage:0.6,NEU (ANC):4.6 LY:0.6, IG: 0.0. Chemistries: Glucose:109, BUN:13.0, Creatinine:1.0. BUN/Creatinine ratio:13.4. Sodium: 143,Pptassoi,4.0,choloride:1.5,co2:2:26.0,calcium: 8.9, corrected calcium 9:50,Albumin: 3.4. Total protein:6.5. Globulin: 3.1. A/G Ratio: 1.1. Bilirubin, total: 0.1. Alkaline phosphatase: 53.SGOT/AST: 19.SGPT/ALT: 16.GFR estimate: 56. Tumor markers: CA 27-29; 26. Anemia labs: Irons: 80, TIBC: 238, Iron,percentage saturation: 34, Ferritin: 440. The current medications was reported below. ARIMIDEX, per oral solid: 1mg Tablet Take 1 per oral daily. Calcium +D, PO solid: Outside Rx: 500mg-1000 Tablet, chewable take 1 PO TID. Cyclobenzaprine HCL, PO solid: Outside Rx: 10 mg Tablet Take 1 PO TID. Fentanyl, top: Outside Rx: 50MCG/HR Patch(es), transdermal Take 1 Patch(es) Topical Q72H as directed. Hydrocodone/acetaminophen, PO solid: Outside Rx: 10mg-325 MG Tablet Take 1 PO Q4HPRN plan. Loperamide HCL: Outside Rx: 1 mg/7.5 ml Liquid (ml) Take 5 mL PO PRN Date started: 3rd March 2014. Potassium chloride: 20meq/15m 1 liquid (ml) Take 20 mEq PO daily, date started :26th March 2014. LIDODERM 5% Adhesive patch, medicated Take 1 Patch(es) topical daily, Date started: 8th October 2014. LOMOTIL, PO solid 2.5-0 25 mg Tablet 1 PO QID PRN, date started :26th March 2014. Meloxicam, PO solid: Outside Rx: 7.5 mg Tablet Take 1 PO daily. NEXIUM. PO solid Outside Rx: 20 mg Capsule(s) 1 delayed release (enteric coated) Take 1 Capsule(s) PO daily. Prednisone, PO solid: Outside Rx 1o mg Tablet Take 1 PO as directed. Probiotic and acidophilus, PO solid: Outside Rx: 300 mm--250 Capsule Take 1 PO daily. VALIUM, PO solid: 5 mg Tablet Take 1 PO PRN, Dated started: 18TH March 2015. Vitamin B12, PO solid Outside Rx: 1000 mcg Tablet Take 1 PO as directed. Allergies and adverse reactions reported as below: Exernestane, PO solid (supplied by sponsor), reaction was nausea, swelling. BONIVA, PO solid, reaction hives, rash. Penicillins. FLUARIX, syringe, swelling. Cortizone 10, vomiting, weakness. LYRICA, PO solid reactions: hives, stomach upset Sulfa drugs, reactions: hives, stomach upset. Adult aspirin, PO solid, reaction: hives. The directives: medical power of attorney: no, financial power of attorney: no, healthcare agent/proxy designee spouse. Code status: full code. Special considerations was varicella status: chicken pox: yes. The problem list was breast cancer female, carcinoma of unknown primary, anemia, iron deficiency, headaches, dehydration, anemia and bone metastasi. Today Regimen orders: XGEVA Borie Metastasis C43D1. Regimen Instructions: Today XGEVA: 120 mg as directed sub Q administer in upper arm, upper thigh, or abdomen. Diphenhydramine HCL, injection: 50 mg PRN Hypersensitivity Reaction I.V. Re-initiate treatment only upon physician approval. Hydrocortisone sod succinate, injection: 100 mg PRN Hypersensitivity Reaction I.V. Re-initial treatment only upon physician approval. Methylprednisolone sod succ. injection: 125 mg PRN Hypersensitivity Reaction I.V. Re-initiate treatment only upon physician approval. Palboclolib with Fulvestrant CBD1. Regimen Instructions: Today Palbocicilb, PO solid: 125 mg Capsule Take 1 PO as directed daily dispense 21, Refills: 5. Instructions: Take 1 capsule (125 mg) by mouth daily days 1-21. Take whole with water and food, at approximately the same time each day. Fulvestrant, syringe: 500 mg CYCLE 2+ IM administer as two concurrent 5 mL injections one in each buttock. The injection should be administered slowly. Total dose administered was 500 mg. For pre and peri-menopausal women consider including GNRN agonist therapy for ovarian function suppression. Diphenhydramine HCL, injection: 50 mg PRN hypersensitivity reaction [I.V. From C7D1 to End of Regimen, re-initiate treatment only upon physician approval. Hydrocortisone dose succinate, Injection: 100 mg PRN hypersensitivity reaction I.V. From C7D1 to end of Regimen, re-initiate treatment only upon physician approval. Methyiprednisolone sod succ, Injection: 125 mg PRN hypersensitivity reaction LV. From C7D1 to end of Regimen, Re-initiate treatment only upon physician approval. InFed IV Infusion C3D1. IV access: peripheral IV, site: right, forearm, needle type: 24 g angio cath, attempts: l, infusion comments: inserted peripheral IV catheter, obtained blood return, primary bag, 0.9 percent sodium chloride, Injection, 100 ml, start time: 11:18, stop time: 13:50, infusion DIC comments: IV infusion completed, therapy completed without adverse event Peripheral IV removed, catheter removed intact, occlusive dressing applied, no redness, no swelling, no tenderness, no bruising at IV site. Regimen instruction: today. InFed: 500 mg as directed IVPB, Rate: Over 4-6 hours mix in 250-1000 mL NS. If test dose is uneventful after 1 hour of observation , then infuse the remaining calculated total Iron dextran dose over 4-6 hours. Systemic reactions which may occur after intravenous administration include fever, chills, backache, myalgia, dizziness, syncope and rash. Anaphylaxis may occur immediately or be delayed. Have epinephrine (subcutaneous) available. Diphenhydramine HCL, Injection: 50 mg PRN hypersensitivity reaction I.V Re.4nitiate treatment only upon physician approval. Hydrocortisone sod succinate, inj: 100 mg PRN hypersensitivity reaction IV. re-initiate treatment only upon physician approval. Methyl prednisone sod succinate, inj: 125 mg PRN hypersensitivity reaction IV. re-initiate treatment only upon physician approval. The new orders was reported below: IBRANCE, PO solid: 100mg Capsule Take 1 PO daily. RTC MD: Prior to next visit, Print on Rx, instructions/comments- cont XGEVA, fulvestrant, and iron dextran today, next minus iron is in 4 weeks. CA 27-29, OSC w/auto cliff, MP: On return, print on Rx. Iron and TIBC Ferritin panel: On return, Print on Rx. The nurses notes reported below: IV. Access IV. Access: peripheral IV Site: right, forearm, Needle type: 24 g anglo cath, Attempts: 1, Infusion comments; inserted peripheral IV catheter, obtained blood return, primary bag, 0.9 percent sodium chloride, injection 100 ml, start time: 11:18, stop time: 13:50, Infusion DIC comments: IV infusion completed, therapy completed without adverse event, Peripheral IV removed, catheter removed intact1 occlusive dressing applied, no redness, no swelling, no tenderness, no bruising at IV site. Medications: XGEVA, injection: Given: 120 mg sub-Q, Time: 11:24, site of admin, SG: RLQ of abdomen. Fulvestrant, syringe: Given: 600 mg IM, Time: 14:00, site of admin, IM: Left gluteus, upper outer quadrant, Right gluteus, upper outer quadrant. InFed: Given: 500 mg IVPB, Start time: 11:24, Stop time: 13:24. The patient assessments was performed: Hematologic labs verified. For constitutional fatigue no fever, no weakness, no chills. For oral there was no soreness, no dryness, no redness, no swelling, no ulcerations, no mucositis. For eye: no Impaired vision. For ears/nose there was no nasal congestion, no complaints of tinnitus. For cardiovascular, the skin warm and dry, regular pulse, 604OO beats/mm, BP normal range for patient. For lymphatics, no lymphedema, no adenopathy. For respiratory, no dyspnea, no cough. For gastrointestinal, no nausea, no vomiting, no diarrhea, no constipation, fluid intake adequate, food intake adequate. For genitourinary, no complaints voiced. For musculoskeletal: steady gait. For skin, thin and fragile texture, skin turgor decreased. For neurologic, alert arid oriented, understands and communicated adequately. For psychosocial behavior is appropriated, cooperative, coping well. For sleep there was no complaints voiced. There was no pain. Other notes were reported. Bone metastasis: The patient education was the patient education resources patient referred to portal. Electronic signature was visit reviewed and electronically signed.