PSI-HHS-000007183065 attachment

PSI-HHS-000007183065

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hsgac.senate.gov
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DrugEventUS EB05 20210806US Serious EB05 20210806US Fatal EB05 20210806US Infant EB05 20210806US Child EB05 20210806US Teen EB05 20210806US Adult1 EB05 20210806US Adult2 EB05 20210806US Adult3 EB05 20210806US Female EB05 20210806US Male EB05 20210806Comment
COVID19 (COVID19 (JANSSEN))Activated partial thromboplastin time prolonged1.7061.6560.8941.3661.4161.2882.0460.943
COVID19 (COVID19 (JANSSEN))Activated partial thromboplastin time shortened1.7991.7360.8881.451.7921.2252.0631.189
COVID19 (COVID19 (JANSSEN))Adverse drug reaction2.5250.9040.8920.7580.7120.6892.1471.49
COVID19 (COVID19 (JANSSEN))Adverse event2.0430.9860.8920.9490.7020.6991.481.574
COVID19 (COVID19 (JANSSEN))Angiogram cerebral abnormal3.132.5860.8970.5171.6122.1593.544.2921.384
COVID19 (COVID19 (JANSSEN))Angiogram pulmonary abnormal2.3732.1450.8930.4781.5362.4371.7162.3781.931
COVID19 (COVID19 (JANSSEN))Antibody test1.8940.820.6611.8322.3731.7231.492
COVID19 (COVID19 (JANSSEN))Anticoagulant therapy2.0341.8340.9210.6120.3961.7231.9481.9922.6661.359
COVID19 (COVID19 (JANSSEN))Areflexia1.7582.0770.890.8171.731.0261.3471.342
COVID19 (COVID19 (JANSSEN))Blood fibrinogen decreased2.6552.5090.8930.5361.211.5950.6593.8660.859
COVID19 (COVID19 (JANSSEN))CSF protein increased2.1982.2050.891.4272.0950.9611.6591.842
COVID19 (COVID19 (JANSSEN))Cerebral haemorrhage2.0131.9790.9080.5391.71.8431.2632.5551.087
COVID19 (COVID19 (JANSSEN))Cerebral venous sinus thrombosis3.1752.5820.8990.5412.332.8530.743.8291.207
COVID19 (COVID19 (JANSSEN))Computerised tomogram head abnormal2.4532.1410.920.6120.4872.0212.2971.8143.1541.551
COVID19 (COVID19 (JANSSEN))Computerised tomogram thorax abnormal1.981.8080.8970.511.4871.9981.6552.2531.447
COVID19 (COVID19 (JANSSEN))Deep vein thrombosis2.3481.8760.9090.4772.0982.0852.82.851.819
COVID19 (COVID19 (JANSSEN))Fibrin D dimer2.3331.5460.8950.4142.292.0671.8242.6611.513
COVID19 (COVID19 (JANSSEN))Fibrin D dimer increased1.9321.4890.8990.610.3281.5572.1311.6542.2751.26
COVID19 (COVID19 (JANSSEN))Gaze palsy2.2680.9590.8912.3721.720.7922.7211.209
COVID19 (COVID19 (JANSSEN))Guillain-Barre syndrome1.8551.8460.891.1852.3511.1271.7241.69
COVID19 (COVID19 (JANSSEN))Heparin-induced thrombocytopenia test4.8783.3760.8962.1414.1234.0965.8371.342
COVID19 (COVID19 (JANSSEN))Heparin-induced thrombocytopenia test positive5.5992.8920.5583.3791.9460.6726.1261.043
COVID19 (COVID19 (JANSSEN))Immunoglobulin therapy1.811.9810.8910.0411.6942.1071.2971.7981.494
COVID19 (COVID19 (JANSSEN))Jugular vein thrombosis2.1292.2190.8911.4721.2040.7412.7320.712
COVID19 (COVID19 (JANSSEN))Lumbar puncture abnormal1.8111.8940.9072.0310.9111.2761.608
COVID19 (COVID19 (JANSSEN))Magnetic resonance imaging head abnormal1.9861.8810.8930.4711.7361.8161.7852.2651.448
COVID19 (COVID19 (JANSSEN))Off label use1.6520.2430.894.860.3480.610.3461.0571.558
COVID19 (COVID19 (JANSSEN))On and off phenomenon1.6030.7562.2631.0041.976
COVID19 (COVID19 (JANSSEN))Pain assessment2.0170.850.541.4681.9290.971.961.146
COVID19 (COVID19 (JANSSEN))Peripheral embolism3.9371.9980.8910.6511.021.9112.5030.921
COVID19 (COVID19 (JANSSEN))Platelet count2.2872.4570.9050.6120.5032.0823.0831.3722.7951.436
COVID19 (COVID19 (JANSSEN))Platelet count normal2.572.2570.8960.2812.012.9382.0243.2321.54
COVID19 (COVID19 (JANSSEN))Platelet factor 45.1653.1610.8913.1551.8090.6914.9031.241
COVID19 (COVID19 (JANSSEN))Poor quality product administered0.4630.5692.4282.0364.0312.412.312
COVID19 (COVID19 (JANSSEN))Pulmonary embolism1.9951.7630.9110.6120.6521.5621.9842.1312.2751.602
COVID19 (COVID19 (JANSSEN))Therapy non-responder4.5942.6286.17811.9185.3734.006
COVID19 (COVID19 (JANSSEN))Thrombocytopenia1.7981.8680.8940.4241.5981.9321.1442.091.253
COVID19 (COVID19 (JANSSEN))Thrombophlebitis superficial2.2391.1220.8920.5521.3111.7771.21.9271.59
COVID19 (COVID19 (JANSSEN))Thrombosis2.2752.3641.7650.6120.6082.082.343.042.5891.843
COVID19 (COVID19 (JANSSEN))Transverse sinus thrombosis2.1871.9020.8911.591.190.6542.1220.877
COVID19 (COVID19 (JANSSEN))Ultrasound Doppler2.1241.3020.8940.5861.8411.9591.7472.4561.413
COVID19 (COVID19 (JANSSEN))Ultrasound Doppler abnormal2.6312.1740.9010.6122.0812.1743.2662.8012.12
COVID19 (COVID19 (JANSSEN))Ultrasound Doppler normal2.2071.6642.4621.3911.2572.3521.354
COVID19 (COVID19 (JANSSEN))Vaccination failure1.0481.340.8960.5240.9662.0913.9891.41.601
COVID19 (COVID19 (JANSSEN))Venogram2.1942.0181.6631.6340.5612.230.924
COVID19 (COVID19 (JANSSEN))Venogram abnormal3.2512.5960.5322.5861.7930.6994.2231.047
COVID19 (COVID19 (JANSSEN))Venogram normal3.8962.4110.8912.7622.3770.7474.9420.897
COVID19 (COVID19 (MODERNA))Accidental exposure to product2.1280.3850.5190.4710.7380.6790.77
COVID19 (COVID19 (MODERNA))No adverse event1.5680.810.8910.472.1270.9230.9690.8911.2371.343
COVID19 (COVID19 (MODERNA))Poor quality product administered2.4770.5450.2870.2580.3740.5650.4430.377
COVID19 (COVID19 (MODERNA))Product administered to patient of inappropriate age2.3730.8670.8910.7632.4370.0840.2360.6532.3312.392
COVID19 (COVID19 (PFIZER-BIONTECH))Product preparation issue1.8261.3881.8731.8542.0591.8031.772
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Sheet: data
Drug | Event | US EB05 20210806 | US Serious EB05 20210806 | US Fatal EB05 20210806 | US Infant EB05 20210806 | US Child EB05 20210806 | US Teen EB05 20210806 | US Adult1 EB05 20210806 | US Adult2 EB05 20210806 | US Adult3 EB05 20210806 | US Female EB05 20210806 | US Male EB05 20210806 | Comment
COVID19 (COVID19 (JANSSEN)) | Activated partial thromboplastin time prolonged | 1.706 | 1.656 | 0.894 |  |  |  | 1.366 | 1.416 | 1.288 | 2.046 | 0.943 | 
COVID19 (COVID19 (JANSSEN)) | Activated partial thromboplastin time shortened | 1.799 | 1.736 | 0.888 |  |  |  | 1.45 | 1.792 | 1.225 | 2.063 | 1.189 | 
COVID19 (COVID19 (JANSSEN)) | Adverse drug reaction | 2.525 | 0.904 | 0.892 |  |  |  | 0.758 | 0.712 | 0.689 | 2.147 | 1.49 | 
COVID19 (COVID19 (JANSSEN)) | Adverse event | 2.043 | 0.986 | 0.892 |  |  |  | 0.949 | 0.702 | 0.699 | 1.48 | 1.574 | 
COVID19 (COVID19 (JANSSEN)) | Angiogram cerebral abnormal | 3.13 | 2.586 | 0.897 |  |  | 0.517 | 1.612 | 2.159 | 3.54 | 4.292 | 1.384 | 
COVID19 (COVID19 (JANSSEN)) | Angiogram pulmonary abnormal | 2.373 | 2.145 | 0.893 |  |  | 0.478 | 1.536 | 2.437 | 1.716 | 2.378 | 1.931 | 
COVID19 (COVID19 (JANSSEN)) | Antibody test | 1.894 | 0.82 |  |  |  |  | 0.661 | 1.832 | 2.373 | 1.723 | 1.492 | 
COVID19 (COVID19 (JANSSEN)) | Anticoagulant therapy | 2.034 | 1.834 | 0.921 | 0.612 |  | 0.396 | 1.723 | 1.948 | 1.992 | 2.666 | 1.359 | 
COVID19 (COVID19 (JANSSEN)) | Areflexia | 1.758 | 2.077 | 0.89 |  |  |  | 0.817 | 1.73 | 1.026 | 1.347 | 1.342 | 
COVID19 (COVID19 (JANSSEN)) | Blood fibrinogen decreased | 2.655 | 2.509 | 0.893 |  |  | 0.536 | 1.21 | 1.595 | 0.659 | 3.866 | 0.859 | 
COVID19 (COVID19 (JANSSEN)) | CSF protein increased | 2.198 | 2.205 | 0.89 |  |  |  | 1.427 | 2.095 | 0.961 | 1.659 | 1.842 | 
COVID19 (COVID19 (JANSSEN)) | Cerebral haemorrhage | 2.013 | 1.979 | 0.908 |  |  | 0.539 | 1.7 | 1.843 | 1.263 | 2.555 | 1.087 | 
COVID19 (COVID19 (JANSSEN)) | Cerebral venous sinus thrombosis | 3.175 | 2.582 | 0.899 |  |  | 0.541 | 2.33 | 2.853 | 0.74 | 3.829 | 1.207 | 
COVID19 (COVID19 (JANSSEN)) | Computerised tomogram head abnormal | 2.453 | 2.141 | 0.92 | 0.612 |  | 0.487 | 2.021 | 2.297 | 1.814 | 3.154 | 1.551 | 
COVID19 (COVID19 (JANSSEN)) | Computerised tomogram thorax abnormal | 1.98 | 1.808 | 0.897 |  |  | 0.51 | 1.487 | 1.998 | 1.655 | 2.253 | 1.447 | 
COVID19 (COVID19 (JANSSEN)) | Deep vein thrombosis | 2.348 | 1.876 | 0.909 |  |  | 0.477 | 2.098 | 2.085 | 2.8 | 2.85 | 1.819 | 
COVID19 (COVID19 (JANSSEN)) | Fibrin D dimer | 2.333 | 1.546 | 0.895 |  |  | 0.414 | 2.29 | 2.067 | 1.824 | 2.661 | 1.513 | 
COVID19 (COVID19 (JANSSEN)) | Fibrin D dimer increased | 1.932 | 1.489 | 0.899 | 0.61 |  | 0.328 | 1.557 | 2.131 | 1.654 | 2.275 | 1.26 | 
COVID19 (COVID19 (JANSSEN)) | Gaze palsy | 2.268 | 0.959 | 0.891 |  |  |  | 2.372 | 1.72 | 0.792 | 2.721 | 1.209 | 
COVID19 (COVID19 (JANSSEN)) | Guillain-Barre syndrome | 1.855 | 1.846 | 0.89 |  |  |  | 1.185 | 2.351 | 1.127 | 1.724 | 1.69 | 
COVID19 (COVID19 (JANSSEN)) | Heparin-induced thrombocytopenia test | 4.878 | 3.376 | 0.896 |  |  |  | 2.141 | 4.123 | 4.096 | 5.837 | 1.342 | 
COVID19 (COVID19 (JANSSEN)) | Heparin-induced thrombocytopenia test positive | 5.599 | 2.892 |  |  |  | 0.558 | 3.379 | 1.946 | 0.672 | 6.126 | 1.043 | 
COVID19 (COVID19 (JANSSEN)) | Immunoglobulin therapy | 1.81 | 1.981 | 0.891 |  |  | 0.041 | 1.694 | 2.107 | 1.297 | 1.798 | 1.494 | 
COVID19 (COVID19 (JANSSEN)) | Jugular vein thrombosis | 2.129 | 2.219 | 0.891 |  |  |  | 1.472 | 1.204 | 0.741 | 2.732 | 0.712 | 
COVID19 (COVID19 (JANSSEN)) | Lumbar puncture abnormal | 1.811 | 1.894 |  |  |  |  | 0.907 | 2.031 | 0.911 | 1.276 | 1.608 | 
COVID19 (COVID19 (JANSSEN)) | Magnetic resonance imaging head abnormal | 1.986 | 1.881 | 0.893 |  |  | 0.471 | 1.736 | 1.816 | 1.785 | 2.265 | 1.448 | 
COVID19 (COVID19 (JANSSEN)) | Off label use | 1.652 | 0.243 | 0.89 |  |  | 4.86 | 0.348 | 0.61 | 0.346 | 1.057 | 1.558 | 
COVID19 (COVID19 (JANSSEN)) | On and off phenomenon | 1.603 | 0.756 |  |  |  |  | 2.263 | 1.004 |  | 1.976 |  | 
COVID19 (COVID19 (JANSSEN)) | Pain assessment | 2.017 | 0.85 |  |  |  | 0.54 | 1.468 | 1.929 | 0.97 | 1.96 | 1.146 | 
COVID19 (COVID19 (JANSSEN)) | Peripheral embolism | 3.937 | 1.998 | 0.891 |  |  |  | 0.651 | 1.02 | 1.911 | 2.503 | 0.921 | 
COVID19 (COVID19 (JANSSEN)) | Platelet count | 2.287 | 2.457 | 0.905 | 0.612 |  | 0.503 | 2.082 | 3.083 | 1.372 | 2.795 | 1.436 | 
COVID19 (COVID19 (JANSSEN)) | Platelet count normal | 2.57 | 2.257 | 0.896 |  |  | 0.281 | 2.01 | 2.938 | 2.024 | 3.232 | 1.54 | 
COVID19 (COVID19 (JANSSEN)) | Platelet factor 4 | 5.165 | 3.161 | 0.891 |  |  |  | 3.155 | 1.809 | 0.691 | 4.903 | 1.241 | 
COVID19 (COVID19 (JANSSEN)) | Poor quality product administered | 0.463 |  |  |  |  | 0.569 | 2.428 | 2.036 | 4.031 | 2.41 | 2.312 | 
COVID19 (COVID19 (JANSSEN)) | Pulmonary embolism | 1.995 | 1.763 | 0.911 | 0.612 |  | 0.652 | 1.562 | 1.984 | 2.131 | 2.275 | 1.602 | 
COVID19 (COVID19 (JANSSEN)) | Therapy non-responder | 4.594 |  |  |  |  |  | 2.628 | 6.178 | 11.918 | 5.373 | 4.006 | 
COVID19 (COVID19 (JANSSEN)) | Thrombocytopenia | 1.798 | 1.868 | 0.894 |  |  | 0.424 | 1.598 | 1.932 | 1.144 | 2.09 | 1.253 | 
COVID19 (COVID19 (JANSSEN)) | Thrombophlebitis superficial | 2.239 | 1.122 | 0.892 |  |  | 0.552 | 1.311 | 1.777 | 1.2 | 1.927 | 1.59 | 
COVID19 (COVID19 (JANSSEN)) | Thrombosis | 2.275 | 2.364 | 1.765 | 0.612 |  | 0.608 | 2.08 | 2.34 | 3.04 | 2.589 | 1.843 | 
COVID19 (COVID19 (JANSSEN)) | Transverse sinus thrombosis | 2.187 | 1.902 | 0.891 |  |  |  | 1.59 | 1.19 | 0.654 | 2.122 | 0.877 | 
COVID19 (COVID19 (JANSSEN)) | Ultrasound Doppler | 2.124 | 1.302 | 0.894 |  |  | 0.586 | 1.841 | 1.959 | 1.747 | 2.456 | 1.413 | 
COVID19 (COVID19 (JANSSEN)) | Ultrasound Doppler abnormal | 2.631 | 2.174 | 0.901 | 0.612 |  |  | 2.081 | 2.174 | 3.266 | 2.801 | 2.12 | 
COVID19 (COVID19 (JANSSEN)) | Ultrasound Doppler normal | 2.207 | 1.664 |  |  |  |  | 2.462 | 1.391 | 1.257 | 2.352 | 1.354 | 
COVID19 (COVID19 (JANSSEN)) | Vaccination failure | 1.048 | 1.34 | 0.896 |  |  | 0.524 | 0.966 | 2.091 | 3.989 | 1.4 | 1.601 | 
COVID19 (COVID19 (JANSSEN)) | Venogram | 2.194 | 2.018 |  |  |  |  | 1.663 | 1.634 | 0.561 | 2.23 | 0.924 | 
COVID19 (COVID19 (JANSSEN)) | Venogram abnormal | 3.251 | 2.596 |  |  |  | 0.532 | 2.586 | 1.793 | 0.699 | 4.223 | 1.047 | 
COVID19 (COVID19 (JANSSEN)) | Venogram normal | 3.896 | 2.411 | 0.891 |  |  |  | 2.762 | 2.377 | 0.747 | 4.942 | 0.897 | 
COVID19 (COVID19 (MODERNA)) | Accidental exposure to product | 2.128 |  |  |  |  | 0.385 | 0.519 | 0.471 | 0.738 | 0.679 | 0.77 | 
COVID19 (COVID19 (MODERNA)) | No adverse event | 1.568 | 0.81 | 0.891 |  | 0.47 | 2.127 | 0.923 | 0.969 | 0.891 | 1.237 | 1.343 | 
COVID19 (COVID19 (MODERNA)) | Poor quality product administered | 2.477 |  |  |  | 0.545 | 0.287 | 0.258 | 0.374 | 0.565 | 0.443 | 0.377 | 
COVID19 (COVID19 (MODERNA)) | Product administered to patient of inappropriate age | 2.373 | 0.867 | 0.891 |  | 0.763 | 2.437 | 0.084 | 0.236 | 0.653 | 2.331 | 2.392 | 
COVID19 (COVID19 (PFIZER-BIONTECH)) | Product preparation issue | 1.826 |  |  |  |  | 1.388 | 1.873 | 1.854 | 2.059 | 1.803 | 1.772 |