Age: 50.0
Sex: M
Vaccine: SMALL
Symptoms: Skin burning sensation, Swelling, Total cholesterol/HDL ratio normal, Urine ketone body absent, Urine leukocyte esterase
Clinical narrative: Subject is a 50 year old male with history of hypertension and hypercholesterolemia who was vaccinated with ACAM2000 (lot VV03-012-B) on 08SEP2018 at 08:30 hr. Concomitant medications included simvastatin, multivitamin, hydrochlorothiazide, benazepril and amlodipine. On 10SEP2018, the subject stated that he started to feel heat in his armpits, inner elbows and feet and noticed that those areas started to turn red with some hives. The subject also indicated that he felt a little nauseous, fever of 100.5F and a headache. The subject took ALEVE and BENADRYL and noted improvement. As of 11SEP2018, the redness spread to most of the body, and so he went to the vaccination clinic for evaluation. An EKG was performed and noted as abnormal, insignificant; vital signs were normal. Other than feeling his skin was burning, he had no other symptoms. The study centre physician was consulted, and the subject was advised to take BENADRYL every 4-6 hours, and if symptoms got worse, to go to his emergency department. On 12SEP2018, the subject returned to the vaccination clinic where he was referred to emergency, as the redness worsened, although the swelling and urticaria had improved. The vaccination site was covered as was recommended for the physician who gave it, no issue. The patient was admitted to hospital on 12SEP2018 with confluent rash on arms and legs with dark erythema. Relevant labs: CK 241 U/L, 246 next day (N 24-200), eosinophils 12.5%, creatinine 1.41 mg/dL (N 0.60-1.20). Hemoglobin dropped from 15.7 to 14.1 over three days (1.6 g/dL).Treatment with steroids 125mg IV, Q6h was started. After 24 hours he had a good response and the steroids were decreased to 40mg QD PO. While in the hospital, the subject developed an acute kidney which improved with intravenous fluids. He was started on 25mg metoprolol bid with poor response and would be discharged on 50 mg. He was to be discharged on SOLUMEDROL package for weaning the steroids. Based on the information available, the PI considers the urticaria, rash and headache to be serious. The relationship to ACAM2000 was not reported. Additional laboratory data: 12SEP2018: Mean cell haemoglobin concentration 33.8 g/dL (Reference range 31.7 - 36.1 g/dL) Mean cell volume 88.6 FL (Reference range 82.4 - 99.3 FL) Mean platelet volume 9.3 FL (low) (Reference range 9.7 - 12.5 FL) Monocyte count 0.32 x1000/uL (Reference range 0.00 - 0.80 x1000/uL) Monocyte percentage 5.7 % (Reference range 1-15 %) Neutrophil count 2.89 10*3/µL (Reference range 1.50 - 7.50 10*3/µL) Neutrophil percentage 52.1 % (Reference range 50.0 - 70.0 %) Oxygen saturation 100 % on room air (normal) Platelet count 211 x1000/uL (Reference range 139-361) Red blood cell count 5.25 x10E6/uL (Reference range 4.00 - 5.65 x10E6/uL) Red cell distribution width 12.9 % (Reference range 11.4 - 14.9) Respiratory rate 14 breaths/min (normal) Vital signs measurement within limits White blood cell count 5.59 x1000/uL (Reference range 4.40 - 10.50) 13SEP2018: Mean cell haemoglobin concentration 34.1 g/dL (Reference range 31.7 - 36.1 g/dL) Mean cell volume 87.8 FL (Reference range 82.4 - 99.3 FL) Mean platelet volume 9.5 (low) (Reference range 9.7 - 12.5 FL) Monocyte count 0.04 x1000/uL  (Reference range 0.00 - 0.80 x1000/uL) Monocyte percentage 1.0 % (Reference range 1-15 %) Neutrophil count 2.59 10*3/µL  (Reference range 1.50 - 7.50 10*3/µL) Neutrophil percentage 65.3 % (Reference range 50.0 - 70.0 %) Non-high-density lipoprotein cholesterol 142 mg/dL (high) (Referencerange <130) Platelet count 223 x1000/uL (Reference range 139-361) Red blood cell count 5.08 x10E6/uL (Reference range 4.00 - 5.65 x10E6/uL) Red cell distribution width 12.4 % (Reference range 11.4 - 14.9) Total cholesterol/HDL ratio 4.9 (high) (Reference range 0-4.5) Very low density lipoprotein 12 mg/dL (Reference range 5-40) White blood cell count 3.99 x1000/uL (low) Reference range 4.40 - 10.50) 14SEP2018: Mean cell haemoglobin 29.9 pg (Reference range 27.5 - 34.1 pg) Mean cell haemoglobin concentration 34.3 g/dL (Reference range 31.7 - 36.1 g/dL) Mean cell volume 87.2 FL (Reference range 82.4 - 99.3 FL) Mean platelet volume 10.0 FL (Reference range 9.7 - 12.5 FL) Monocyte count 1.64 x1000/uL (high)  (Reference range 0.00 - 0.80 x1000/uL) Monocyte percentage 9.2 % (Reference range 1-15 %) Neutrophil count 13.26 10*3/µL (high)  (Reference range 1.50 - 7.50 10*3/µL) Neutrophil percentage 74.4 % (high) (Reference range 50.0 - 70.0 %Nitrite urine negative (Reference range: negative) Oxygen saturation 96 % pH urine 6.0 (Reference range 5.0-8.5) Platelet count 223 x1000/uL (Reference range 139-361) Prothrombin time 14.9 seconds (Reference range 11.5-14.9) Red blood cell count 4.75 x10E6/uL (Reference range 4.00 - 5.65 x10E6/uL) Red cell distribution width 12.4 % (Reference range 11.4 - 14.9 Respiratory rate 17 breaths/min (normal) Urine ketone body negative (Reference range negative)Urine leukocyte esterase negative (Reference range negative) Urobilinogen urine 2+ (abnormal)White blood cell count 17.82 x1000/uL (high)  (Reference range 4.40 - 10.50) Calc CrCl by Cockcroft-Gault 92.05 ml/min 15SEP2018: Mean cell haemoglobin 30.4 pg (Reference range 27.5 - 34.1 pg) Mean cell haemoglobin concentration 33.2 g/dL (Reference range 31.7 - 36.1 g/dL) Mean cell volume 91.6 FL (Reference range 82.4 - 99.3 FL) Mean platelet volume 10.0 FL (Reference range 9.7 - 12.5 FL) Oxygen saturation 97 % Platelet count 208 x1000/uL (Reference range 139-361) Protein total 5.4 g/dL (Reference range 6.5-8.0) Red blood cell count 4.64 x10E6/uL (Reference range 4.00 - 5.65 x10E6/uL) Red cell distribution width 12.5 % (Reference range 11.4 - 14.9) Respiratory rate 16 breaths/min (normal) White blood cell count 14.08 x1000/uL (high) (Reference range 4.40 - 10.50) Calc CrCl by Cockcroft-Gault 99.44ml/min.