Age: 84.0
Sex: M
Vaccine: FLUX
Symptoms: Neutrophil count decreased, Normochromic normocytic anaemia, Oedema, Platelet count normal, Pneumonia
Clinical narrative: Case number PHEH2014US013462, is an initial spontaneous report from a nurse via pharmaceutical company received on 30 Jun 2014. This report refers to an 84-year-old male patient. Past medical history included, on 06 Dec 2012 left radical nephrectomy showed grade 3 clear cell carcinoma of kidney with lymphovascular invasion and negative margins, pathologic stage T3a NX. On 14 Dec 2012, computerized tomogram (CT) abdomen and pelvis showed small bowel obstruction and no overt metastases. On 17 Jul 2013, CT showed increase in pulmonary nodule from 8mm to 13 mm and also progressive right lung metastases interval enlargement of the enhancing nodule in the left nephrectomy bed. He had a history of severe proteinuria, allergy to nifedipine and experienced facial swelling due to nifedipine, chronic lumbar pain since 1970 when he fractured his back and this has not changed lately and was not related to any radiculopathy or focal lower extremity weakness. Familial history included malignancy. This polymedicated patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in Sep 2013. On 03 Oct 2013, he started treatment with temsirolimus weekly at an unknown dose. On an unknown date, he experienced pneumonia with hypoxia, pneumonitis and bradycardia. On 22 Nov 2013, he was hospitalized and on 02 Dec 2013 he was discharged. CT on 21 Nov 2013 and 04 Dec 2013 showed improvement in his cancer burden. It was reported that temsirolimus may have caused or complicated pneumonitis and bradycardia. Therapy with temsirolimus was stopped on 14 Nov 2013 (cycle 2, day 15). On 06 Dec 2013, treatment with pazopanib was started at an unknown dose. On 31 Jan 2014, he visited oncology clinic with a blood pressure of 220/83 and worsening proteinuria. Therapy with pazopanib was stopped and treatment with APRESOLINE was started. He experienced pneumonia with influenza A, bradycardia amidst intermittent second degree A V block. On 10 Feb 2014, he was hospitalized and on 17 Feb 2014, he was discharged. He remained off of pazopanib due to these events. On an unknown date, he experienced generalized weakness, pitting edema to the ankles persisting bilaterally and fatigue on occasion with exertion. He rests and has naps twice a day for about two hours. Also he experienced normocytic anemia, elevated thyroid stimulating hormone and blood creatinine. Around 04 Apr 2014, treatment with pazopanib was restarted at a dose of 400 mg per day. On 30 May 2014, CT showed no overt progression of kidney cancer. Due to fatigue and the dose of pazopanib was reduced to 200 mg per day on Monday, Wednesday and Friday while continuing 400 mg per day on the other days from 02 Jun 2014. He denied any recent falls and with regard to kidney cancer, he denied any specific signs and symptoms. Physical examination of chest showed slight prolongation of the expiratory phase bilaterally. The respiratory effort yet again remains unlabored. The lungs again remain clear to auscultation bilaterally. Cardiovascular examination: regular rate and rhythmic normal S 1, S 2. A 2/6 systolic murmur heard maximally at the apex. No rubs or gallops. It was reported that he stated that his blood pressure was under control over the last several weeks that it was today. However, a review of the medical records seems to bear this out. He verified he had a follow up with physician from nephrology on 10 Mar 2014, regarding the bradycardia and proteinuria. ECoG performance status was remains in 2-3 range diminished versus Jan 2014 on 03 Mar 2014 and remains in 1 range unchanged from last visit on diminished versus Jan 2014 on 02 Jun 2014. He underwent following lab tests: blood thyroid stimulating hormone on 30 May 2014 was 0.97, blood thyroid stimulating hormone on 19 May 2014 was 4.61, thyroxine free on 19 May 2014 was 1.2ng/dl and thyroxine free on 31 Jan 2014 was 1.1ng/ml. Carbon dioxide on 03 Mar 2014 was 23, carbon dioxide on 30 May 2014 was 24, oxygen saturation was 98%, basophil count on 03 Mar 2014 was 0.03, basophil count on 30 May 2014 was 0.00, eosinophil count on 03 Mar 2014 was 0.20, eosinophil count on 30 May 2014 was 0.18, lymphocyte count on 03 Mar 2014 was 1.05, lymphocyte count on 30 May 2014 was 1.37, monocyte count on 03 Mar 2014 was 0.80, monocyte count on 30 May 2014 was 0.35, neutrophil count on 03 Mar 2014 was 1.05, neutrophil count on 30 May 2014 was 2.13, white blood cell count on 03 Mar 2014 was 5.59 and white blood cell count on 30 May 2014 was 4.04. Blood calcium on 03 Mar 2014 was 9.3, blood calcium on 30 May 2014 was 8.8, blood chloride on 03 Mar 2014 was 105, blood chloride on 30 May 2014 was 107, blood potassium on 03 Mar 2014 was 4.5, blood potassium on 30 May 2014 was 4.4, blood sodium on 03 Mar 2014 was 139, blood sodium on 30 May 2014 was 140, platelet count on 03 Mar 2014 was 328, platelet count on 30 May 2014 was 172, blood urea on 03 Mar 2014 was 29, blood urea on 30 May 2014 was 33, blood creatinine on 03 Mar 2014 was 1.7, blood creatinine on 16 Sep 2013 was 1.3, blood creatinine on 30 May 2014 was 2.1, blood alkaline phosphatase on 03 Mar 2014 was 83, blood alkaline phosphatase on 30 May 2014 was 60, blood lactate dehydrogenase on 03 Mar 2014 was 211, blood lactate dehydrogenase on 30 May 2014 was 269, blood pressure on 31 Jan 2014 was 220/83, blood pressure was 168/70, pulse was 78, body temperature was 36.2 degrees Celsius, respiratory rate 24 on 03 Mar 2014 and blood pressure was 158/60, pulse was 68, body temperature was 36.3 degrees Celsius and respiratory rate 24 on 02 Jun 2014 respectively. Urine analysis on 10 Feb 2014, squamous epithelial cell were none seen and RBC were 1-2. Haematocrit on 03 Mar 2014 was 30.9, haematocrit on 30 May 2014 was 30.4, haemoglobin on 03 Mar 2014 was 10.6, haemoglobin on 30 May 2014 was 10.3, mean cell haemoglobin on 03 Mar 2014 was 31.5, mean cell haemoglobin on 30 May 2014 was 30.7, mean cell haemoglobin concentration on 03 Mar 2014 was 34.3, mean cell haemoglobin concentration on 30 May 2014 was 33.9, mean cell volume on 03 Mar 2014 was 91.7, mean cell volume on 30 May 2014 was 90.7, red blood cell count on 03 Mar 2014 was 3.37 and red blood cell count on 30 May 2014 was 3.35. Blood glucose on 03 Mar 2014 was 147; blood glucose on 30 May 2014 was 97, protein total on 03 Mar 2014 was 6.3, blood bilirubin on 03 Mar 2014 was 0.4, alanine aminotransferase on 03 Mar 2014 was 19, aspartate aminotransferase on 03 Mar 2014 was 18, alanine aminotransferase on 30 May 2014 was 20, aspartate aminotransferase on 30 May 2014 was 20, blood bilirubin on 30 May 2014 was 0.7 and protein total on 30 May 2014 was 6.2. Also on 30 May 2014, he underwent urine analysis which showed the color of urine was yellow and it was clear. The glucose ketones, bilirubin, blood nitrate were negative. Specific gravity was 1.009. His serum BUN and creatinine within acceptable limits and current urinalysis shows only modest proteinuria and TSH level was reassuring. Normocytic anemia was modest and asymptomatic, likely related to chronic illness and perhaps also the pazopanib. His hemoglobin will be monitored. Currently, his heart rate was within normal range and his blood pressure likewise was acceptable. The outcome of the event fatigue, proteinuria, normocytic anemia and blood creatinine was condition unchanged; bradycardia, blood pressure 220/83, second degree A V block and elevated thyroid stimulating hormone was recovered; outcome of the other events was not reported. Causality was not reported.