Age: 67.0
Sex: M
Vaccine: FLUX
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood alkaline phosphatase increased, Blood bilirubin normal, Blood calcium normal
Clinical narrative: This spontaneous case, initially received from the other-health care professional (physician) via pharmaceutical manufacturer (Novartis) on 23-Oct-2018, concerns a 67-year-old, elderly male patient of weight 78.8 kg. The patient's family history included prostate cancer and multigenerational melanoma. The patient was a non-smoker and never used tobacco. The patient was alcohol drinker (two glasses of wine per week). The patient had no history of drug usage. The patient had no history of immunisation. The patient's historical procedure included fistula repair and inguinal hernia repair. The patient's historical condition included testicular hypogonadism. On an unspecified date in 1992, the patient's carcinoid tumour of two cm was removed by colonoscopy from the left lower colon. On an unspecified date in 2005, the patient underwent upper pole resection for renal carcinoma stage 1. On 07-Aug-2017, the patient underwent biopsy for metastatic clear cell carcinoma of the kidney abutting bone. On an unspecified date in Jul-2018, the patient completed radiation for primary mass in the ninth rib area and the eight rib. On 08-Aug-2018, the patient had decrease in the size of mass post radiation therapy 7.2cmx4.4cmx3.4cm, continued mass eight rib with increased size to 2.5 cm. On 15-Aug-2018, the patient discontinued the treatment with VOTRIENT. On 23-Aug-2018, the patient started OPDIVO and had complications which included shortness of breath at 7000 feet and involvement of the eight rib with pathological fracture and pain. On an unspecified date, the patient had follow-up for metastatic kidney cancer and patient was normal and doing well. The patient had no complaints of headache, vision changes, shortness of breath, diarrhoea, rashes, itching and pain was almost gone. The patient had dry cough which he felt was related to allergies. The patient's current conditions included hypertension and metastatic cell carcinoma of the kidney T1NXM1, stage IV, right lung, lower lobe, was diagnosed on 20-Jul-2017 and 07-Aug-2017 (as reported), primary mass in the ninth rib area and eight rib, bone metastasis, kidney cancer primary with metastasis from kidney to another site, left (HCC) (as reported). The patient's concomitant medications included VOTRIENT for renal cell carcinoma and OPDIVO for malignant neoplasm metastatic to right lung (HCC) (as reported). On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (anatomical location: left arm, dose, route of administration, batch number, expiry date, trade name and manufacturer: not reported). On an unspecified date, the patient had all the other system reviewed and were negative. On an unspecified date, the patient underwent physical examination which included body surface area (BSA) 2 meters squared, blood pressure was 139/87, pulse rate was 77, body temperature was 36.8 degree Celsius (98.3 F), temporal weight 78.8 kg (173 lb 12.8 oz) and oxygen saturation at 93 percent. The patient's head was normocephalic and atraumatic. The patient's eyes were normal (eyes upon movement), pupils were equal, round and reactive to light. The patient's neck moved in the normal range of motion and was supple (as reported). The patient's cardiovascular system measurement included normal heart rate, regular rhythm and normal heart sounds. The patient's pulmonary system included normal effort and normal breath sounds. The patient had very fine crackles heard in the right lower lobe. The patient's abdominal evaluation was soft and had musculoskeletal test which showed normal range of motion. The patient had no cervical adenopathy and no right or left supraclavicular adenopathy. The patient's neurological test included, alertness and oriented to person, place and time. The patient's skin was warm and dry. The patient's psychiatric test included normal mood and affect, behaviour was normal, judgement and thought content was normal. The patient's pain scale was normal and asymptomatic performance status was normal. The patient used VOTRIENT for one year and then had local progression and toxicity with weight loss from VOTRIENT. The patient had radiation to area which involved right posterior chest. On 23-Aug-2018, the patient started OPDIVO. It was suspected that, right lower lobe rales are radiation related pneumonitis clinical improvement with antibiotic intervention and time. The patient did not use prednisone for now. The patient had trial of medical cannabis for relief from shortness of breath with exercise (this exercise was much improved on OPDIVO post radiation). The total time spent with patient was 20 minutes, out of which 50 percent of the time was spent in face to face counselling and coordination of care. On 06-Sep-2018 at 8:42 hours, the patient underwent lab investigations, creatinine at 0.95, ALT was 69 (high), AST was 39, Alkaline phosphatase was 202 (high), total bilirubin was 0.5, sodium was 144, potassium was 4.4, chloride was 109, carbon dioxide was 29, blood urea nitrogen was 23, calcium was 8.9, normal range and units were not reported. On 04-Oct-2018 at 10:58 hours, the patient underwent lab investigations which included white blood cell at 7.3, haemoglobin at 13.1 (low), haematocrit at 40 (low), mean cell volume at 92, platelets at 231, creatinine at 0.9, ALT at 44 (high), AST at 35, Alkaline phosphatase 160 (high), total bilirubin at 0.4, sodium at 142, potassium at 4.3, chloride at 109, carbon dioxide at 25, blood urea nitrogen at 21 and calcium at 8.8, normal range and units were not reported. On 04-Oct-2018, the patient's renal condition was unchanged and continued with the current treatment regimen. The patient's renal condition would be reassessed one month. The patient continued the treatment with OPDIVO and was doing well. The patient had no immunologic side effects, was eating well and still had little cough. There were fine crackles heard in the right lower lobe. The patient was encouraged to monitor cough (which the patient felt that it was related to allergies) and was advised to report back if it worsened. The patient received the treatment every two weeks. On 18-Oct-2018, the patient came for the office visit. The patient was diagnosed with bone metastasis (HCC) (as reported), malignant neoplasm metastatic to right lung (HCC) (as reported), kidney cancer, primary with metastasis from kidney to another site, left (HCC) (as reported) and cough. The patient was doing well, had gained weight and had no cough. The patient did not have any side effects and labs were stable. The patient would like to see if medical cannabis helped shortness of breath and sleep. On the same day, the patient underwent physical examination which included body surface area (BSA) 2 meters squared, blood pressure 144/87, pulse rate was 77, body temperature was 36.5 degree Celsius (97.7 F), temporal weight 79 kg (174 lb 3.2 oz) and oxygen saturation was 95 percent. The patient appeared well-nourished and with no distress. The patient was much improved with no cough and gained real weight. The patient's oropharynx was clear and moist. The patient's eyes were normal (eyes upon movement), with no scleral icterus. The patient's neck was supple. The patient's cardiovascular system measurement included normal heart rate, regular rhythm and normal heart sounds. The patient's pulmonary system included normal effort and had no wheezes but had rales (right lower lobe). The patient had no cough and no shortness of breath on walking at 5000 feets. The patient's abdominal evaluation no mass and had musculoskeletal test included normal range of motion and does not exhibit any edema. The patient no cervical adenopathy and no right or left supraclavicular adenopathy. The patient's neurological test resulted that patient was alert and oriented to person, place and time. The patient did not have any cranial nerve deficit or sensory deficit and coordination was normal. The patient's skin noted no rash. The patient's psychiatric test included normal mood and affect, behaviour was normal, judgement and thought content was normal. The patient's pain scale was normal and asymptomatic performance status was normal. On the same day, the patient underwent lab investigations which included white blood cell at 8.2, haemoglobin at 14.1, haematocrit at 42, mean cell volume at 92 and platelets at 225, normal range and units were not reported. At the time of report, the outcome of the events cough, dyspnoea, haemoglobin decreased was recovered, the events haematocrit decreased, hepatic enzymes increased and weight decreased was recovering, the event rales was not recovered and the outcome of the events pneumonitis, crepitations, sleep disorder, pain was not reported. The reporter assessed the case as non-serious.