HEADER RECORD*******LIBRARY HEADER RECORD!!!!!!!000000000000000000000000000000 SAS SAS SASLIB 6.06 MAC1. 13NOV23:12:18:4113NOV23:12:18:41 HEADER RECORD*******MEMBER HEADER RECORD!!!!!!!000000000000000001600000000140 HEADER RECORD*******DSCRPTR HEADER RECORD!!!!!!!000000000000000000000000000000 SAS SUPPIE SASDATA 6.06 13NOV23:12:18:4113NOV23:12:18:41 Supplemental Qualifiers for IE HEADER RECORD*******NAMESTR HEADER RECORD!!!!!!!000000001000000000000000000000 STUDYID Study Identifier RDOMAIN Related Domain Abbreviation USUBJID Unique Subject Identifier IDVAR Identifying Variable IDVARVALIdentifying Variable Value %QNAM Qualifier Variable Name &QLABEL Qualifier Variable Label ,QVAL Data Value 3 QORIG Origin  QEVAL Evaluator HEADER RECORD*******OBS HEADER RECORD!!!!!!!000000000000000000000000000000 C4591001IEC4591001 1001 10011001IESEQ1IEDESCDetailsGrade 1 abnormality for WBC and neutrophil CRF C4591001IEC4591001 1001 10011003IESEQ1IEDESCDetailsOn day of first vaccination 5/4/20 - nasal swab collection performed. Test result was positive. CRF C4591001IEC4591001 1001 10011010IESEQ1IEDESCDetails+PCR CRF C4591001IEC4591001 1001 10011016IESEQ1IEDESCDetailsParticipant noted as vaping as of this screening date. CRF C4591001IEC4591001 1001 10011022IESEQ1IEDESCDetailsIgM+ CRF C4591001IEC4591001 1001 10011023IESEQ1IEDESCDetailsasthma;diagnosed 1989;last episode mild Year 2019 April (Mild) CRF C4591001IEC4591001 1001 10011025IESEQ1IEDESCDetailsongoing endocrine evaluation CRF C4591001IEC4591001 1001 10011029IESEQ1IEDESCDetailslymphocytes are a stable Grade 1 abnormality, repeat WBC also had a grade 1 abnormality. Therefore, the participant is a screen failure. CRF C4591001IEC4591001 1001 10011035IESEQ1IEDESCDetailsBMI: 32.94 CRF C4591001IEC4591001 1001 10011035IESEQ2IEDESCDetailsBMI > 30 CRF C4591001IEC4591001 1001 10011036IESEQ1IEDESCDetailshypertension CRF C4591001IEC4591001 1001 10011038IESEQ1IEDESCDetailspsoriasis CRF C4591001IEC4591001 1001 10011047IESEQ1IEDESCDetailsnot willing to comply with vaccination plan CRF C4591001IEC4591001 1001 10011047IESEQ2IEDESCDetailsparticipant signed consent form before staff could answer any questions or concerns CRF C4591001IEC4591001 1001 10011051IESEQ1IEDESCDetailsprescribed a medrol dose pack x 7 days that she completed on 6/2/2020 CRF C4591001IEC4591001 1001 10011051IESEQ2IEDESCDetailsprescribed a medrol dose pack x 7 days that she completed on 6/2/2020 CRF C4591001IEC4591001 1001 10011054IESEQ1IEDESCDetailsparticipant not able to complete rescreen CRF C4591001IEC4591001 1001 10011056IESEQ1IEDESCDetailsHBV core antibody positive CRF C4591001IEC4591001 1001 10011060IESEQ1IEDESCDetailsG1 lab abnormality, not able to complete rescreen CRF C4591001IEC4591001 1001 10011060IESEQ2IEDESCDetailsG1 lab abnormality CRF C4591001IEC4591001 1001 10011062IESEQ1IEDESCDetailspositive antibodies CRF C4591001IEC4591001 1001 10011065IESEQ1IEDESCDetailsBilirubin abnormal CRF C4591001IEC4591001 1001 10011065IESEQ2IEDESCDetailsabnormal labwork CRF C4591001IEC4591001 1001 10011072IESEQ1IEDESCDetailsPer physician, not eligible due to scheduled surgical procedure for basal cell carcinoma this week. CRF C4591001IEC4591001 1001 10011073IESEQ1IEDESCDetailsIgG antibody test result day of screening CRF C4591001IEC4591001 1001 10011074IESEQ1IEDESCDetailsparticipant unable to comply with scheduled visits CRF C4591001IEC4591001 1001 10011075IESEQ1IEDESCDetailsHep B Core AB + CRF C4591001IEC4591001 1001 10011079IESEQ1IEDESCDetailsG1 abnormality CRF C4591001IEC4591001 1001 10011080IESEQ1IEDESCDetailsTested positive for rapid antibody test for IgM CRF C4591001IEC4591001 1002 10021001IESEQ1IEDESCDetailsLab abnormality CRF C4591001IEC4591001 1002 10021001IESEQ2IEDESCDetailsALT 70, AST 100 CRF C4591001IEC4591001 1002 10021002IESEQ1IEDESCDetailsparticipant unable to return for repeat CBC CRF C4591001IEC4591001 1002 10021010IESEQ1IEDESCDetailsHepatitis B positive CRF C4591001IEC4591001 1002 10021046IESEQ1IEDESCDetailsgrade 1 HGB CRF C4591001IEC4591001 1002 10021046IESEQ2IEDESCDetailsSubject deemed to have Chronic Heart Disease by Investigator CRF C4591001IEC4591001 1002 10021048IESEQ1IEDESCDetailsBMI >30 CRF C4591001IEC4591001 1002 10021048IESEQ2IEDESCDetailsBMI >30 CRF C4591001IEC4591001 1002 10021051IESEQ1IEDESCDetailsGrade 2 platelet count CRF C4591001IEC4591001 1002 10021053IESEQ1IEDESCDetailsgrade 1 hemaglobin level, not repeated prior to vaccination CRF C4591001IEC4591001 1002 10021055IESEQ1IEDESCDetailsGrade 2 BUN CRF C4591001IEC4591001 1002 10021056IESEQ1IEDESCDetailsBMI >30 CRF C4591001IEC4591001 1002 10021056IESEQ2IEDESCDetailsBMI >30 CRF C4591001IEC4591001 1002 10021057IESEQ1IEDESCDetailsParticipant decided to have elective surgery during week of vaccination and unable to comply with visit schedule CRF C4591001IEC4591001 1002 10021058IESEQ1IEDESCDetailssubject informed site of vacation plans for July. Subject unable to complete required visits CRF C4591001IEC4591001 1002 10021061IESEQ1IEDESCDetailsGrade 2 BUN CRF C4591001IEC4591001 1002 10021065IESEQ1IEDESCDetailsSubject not able to be vaccinated with 14 days of screening visit CRF C4591001IEC4591001 1002 10021066IESEQ1IEDESCDetailsUnable to vaccinate within 14 day window from screening CRF C4591001IEC4591001 1002 10021070IESEQ1IEDESCDetailsBlood pressure elevated above allowable study limits CRF C4591001IEC4591001 1002 10021076IESEQ1IEDESCDetailsUnable to vaccinate within 14 day window from screening CRF C4591001IEC4591001 1002 10021078IESEQ1IEDESCDetailsBUN grade 1, but unable to rescreen for stability CRF C4591001IEC4591001 1002 10021086IESEQ1IEDESCDetailsUnable to vaccinate subject within 28 days of screening visit CRF C4591001IEC4591001 1003 10031011IESEQ1IEDESCDetailsPositive Hep B CRF C4591001IEC4591001 1003 10031012IESEQ1IEDESCDetailsprevious history of asthma CRF C4591001IEC4591001 1003 10031017IESEQ1IEDESCDetailsNot clinically significant per PI. Protocol Dev. CRF C4591001IEC4591001 1003 10031021IESEQ1IEDESCDetailsNot clinically significant per PI. Protocol Deviation. CRF C4591001IEC4591001 1003 10031033IESEQ1IEDESCDetailsblood pressure at screening visit 188/90 CRF C4591001IEC4591001 1003 10031039IESEQ1IEDESCDetailsSubject has prostate cancer <5 years ago CRF C4591001IEC4591001 1003 10031040IESEQ1IEDESCDetailsBMI >30kg/m2 CRF C4591001IEC4591001 1003 10031041IESEQ1IEDESCDetailsSjogren's syndrome CRF C4591001IEC4591001 1003 10031041IESEQ2IEDESCDetailshas Sjogren's syndrome CRF C4591001IEC4591001 1003 10031042IESEQ1IEDESCDetailsgrade one platelets 139 CRF C4591001IEC4591001 1003 10031044IESEQ1IEDESCDetailsHeart attack 2016 CRF C4591001IEC4591001 1003 10031047IESEQ1IEDESCDetailsNot clinically significant per PI. Protocol Deviation. CRF C4591001IEC4591001 1003 10031048IESEQ1IEDESCDetailsReceived shingles vaccine in last 4 weeks CRF C4591001IEC4591001 1003 10031049IESEQ1IEDESCDetailsBilirubin CRF C4591001IEC4591001 1003 10031052IESEQ1IEDESCDetailsHistory of psoriasis, BP was 173/99, BP 158/98 CRF C4591001IEC4591001 1003 10031060IESEQ1IEDESCDetailsUrea G1 CRF C4591001IEC4591001 1003 10031062IESEQ1IEDESCDetailsLymph G1, bilirubin elevated CRF C4591001IEC4591001 1003 10031064IESEQ1IEDESCDetailsHGB 13.2 G1 CRF C4591001IEC4591001 1003 10031068IESEQ1IEDESCDetailsHep B Core CRF C4591001IEC4591001 1003 10031070IESEQ1IEDESCDetailsNot clinically significant per PI. Protocol Deviation. CRF C4591001IEC4591001 1003 10031073IESEQ1IEDESCDetailslymphocytes too low CRF C4591001IEC4591001 1003 10031074IESEQ1IEDESCDetailsBUN CRF C4591001IEC4591001 1003 10031081IESEQ1IEDESCDetailspsoriasis CRF C4591001IEC4591001 1003 10031084IESEQ1IEDESCDetailsblood pressure CRF C4591001IEC4591001 1003 10031085IESEQ1IEDESCDetailsBUN G2 CRF C4591001IEC4591001 1003 10031140IESEQ1IEDESCDetailsSubject unable to comply with vaccination 2 date CRF C4591001IEC4591001 1003 10031143IESEQ1IEDESCDetailsSubject unable to comply with vaccination 2 date CRF C4591001IEC4591001 1007 10071001IESEQ1IEDESCDetailsBMI CRF C4591001IEC4591001 1007 10071009IESEQ1IEDESCDetailsHistory of exercise induced asthma CRF C4591001IEC4591001 1007 10071010IESEQ1IEDESCDetailsparticipant states term is also tinea versicolor; on physical exam, the skin condition was consistent with vitiligo. The subject was excluded from study participation for this reason CRF C4591001IEC4591001 1007 10071013IESEQ1IEDESCDetailsplatelets clumped at screening blood collection. Unable to reach subject to re-screen the platelets value CRF C4591001IEC4591001 1007 10071018IESEQ1IEDESCDetailsUnable to contact subject after multiple attempts. Labs fell outside of screening window CRF C4591001IEC4591001 1007 10071024IESEQ1IEDESCDetailsSchool schedule change. No longer available for study dates CRF C4591001IEC4591001 1007 10071028IESEQ1IEDESCDetailsparticipant unable to make study visits CRF C4591001IEC4591001 1007 10071030IESEQ1IEDESCDetailsFell outside screening window for labs CRF C4591001IEC4591001 1007 10071033IESEQ1IEDESCDetailselevated blood pressure CRF C4591001IEC4591001 1007 10071036IESEQ1IEDESCDetailsHep B positive result CRF C4591001IEC4591001 1007 10071041IESEQ1IEDESCDetailsno longer available for study CRF C4591001IEC4591001 1007 10071047IESEQ1IEDESCDetailsBMI CRF C4591001IEC4591001 1007 10071048IESEQ1IEDESCDetailstested positive CRF C4591001IEC4591001 1007 10071054IESEQ1IEDESCDetailsno longer available to do study CRF C4591001IEC4591001 1007 10071055IESEQ1IEDESCDetailsout of range systolic blood pressure CRF C4591001IEC4591001 1007 10071059IESEQ1IEDESCDetailsout of range diastolic blood pressure CRF C4591001IEC4591001 1007 10071059IESEQ2IEDESCDetailsout of range diastolic blood pressure CRF C4591001IEC4591001 1007 10071060IESEQ1IEDESCDetailssubject can't make visits CRF C4591001IEC4591001 1007 10071062IESEQ1IEDESCDetailstested positive CRF C4591001IEC4591001 1007 10071069IESEQ1IEDESCDetailsBMI CRF C4591001IEC4591001 1007 10071072IESEQ1IEDESCDetailsNo longer available for study CRF C4591001IEC4591001 1007 10071076IESEQ1IEDESCDetailsBUN remains Grade 2 at re-screen CRF C4591001IEC4591001 1007 10071078IESEQ1IEDESCDetailsno longer available to do study CRF C4591001IEC4591001 1018 10181008IESEQ1IEDESCDetailsUnable to assess chronic diseases. Needs labs studies to assess renal, hepatic and thyroid function. CRF C4591001IEC4591001 1018 10181008IESEQ2IEDESCDetailsUnable to assess stability of chronic diseases without further studies. CRF C4591001IEC4591001 1042 10421005IESEQ1IEDESCDetailsElevated Blood Pressure CRF C4591001IEC4591001 1042 10421006IESEQ1IEDESCDetailsElevated Blood Pressure CRF C4591001IEC4591001 1042 10421007IESEQ1IEDESCDetailsSubject blood Pressure was high, and due to this subject has to go see PCP for hypertension. If subject gets put on a medication the subject will then have to wait per this inclusion CRF C4591001IEC4591001 1042 10421012IESEQ1IEDESCDetailspatient has known history of Hepatitis B CRF C4591001IEC4591001 1042 10421015IESEQ1IEDESCDetailssubject SF due to elevated BP CRF C4591001IEC4591001 1042 10421016IESEQ1IEDESCDetailssubject screen failed in error due to taking what was thought to be a prohibited med CRF C4591001IEC4591001 1042 10421019IESEQ1IEDESCDetailssubject SF due to elevated BP CRF C4591001IEC4591001 1083 10831030IESEQ1IEDESCDetailsHepatitis B History CRF C4591001IEC4591001 1085 10851020IESEQ1IEDESCDetailsCurrently taking immunosuppressive medication CRF C4591001IEC4591001 1089 10891010IESEQ1IEDESCDetailsRheumatoid Arthritis CRF C4591001IEC4591001 1089 10891010IESEQ2IEDESCDetailsbiologic medication CRF C4591001IEC4591001 1089 10891010IESEQ3IEDESCDetailsRA trial at another site CRF C4591001IEC4591001 1089 10891036IESEQ1IEDESCDetailsafter signing consent subject decided he no longer wanted to participate CRF C4591001IEC4591001 1089 10891040IESEQ1IEDESCDetailsafter signing consent subject decided not to continue with trial CRF C4591001IEC4591001 1091 10911009IESEQ1IEDESCDetailsUnable to complete blood draws needed for this trial. CRF C4591001IEC4591001 1107 11071002IESEQ1IEDESCDetailsSUBJECT HAD TO LEAVE SITE BEFORE VACCINATION AFTER RANDOMIZATION. PER SPONSOR IT WAS DECIDED TO SCREEN FAIL. CRF C4591001IEC4591001 1107 11071017IESEQ1IEDESCDetailsTHYROMEGALY FOUND BY PI DURING PHYSICAL. CRF C4591001IEC4591001 1112 11121022IESEQ1IEDESCDetailssubject has upcoming surgery CRF C4591001IEC4591001 1120 11201004IESEQ1IEDESCDetailsSubject had a previous positive COVID test result CRF C4591001IEC4591001 1120 11201009IESEQ1IEDESCDetailsSubject will not agree to contraception methods of protocol. CRF C4591001IEC4591001 1120 11201011IESEQ1IEDESCDetailsSubject received a positive pregnancy test in site after signing consent CRF C4591001IEC4591001 1120 11201022IESEQ1IEDESCDetailsAutoimmune Disease CRF C4591001IEC4591001 1120 11201026IESEQ1IEDESCDetailsPositive for hepatitis C virus CRF C4591001IEC4591001 1123 11231004IESEQ1IEDESCDetailsElevated blood pressure. CRF C4591001IEC4591001 1123 11231024IESEQ1IEDESCDetailsHepatitis C CRF C4591001IEC4591001 1127 11271013IESEQ1IEDESCDetailsSubject is on exclusionary medication Prolia CRF C4591001IEC4591001 1133 11331017IESEQ1IEDESCDetailsElevated blood pressure. CRF C4591001IEC4591001 1133 11331032IESEQ1IEDESCDetailsHepatitis C CRF C4591001IEC4591001 1133 11331035IESEQ1IEDESCDetailssubject has autoimmune disease CRF C4591001IEC4591001 1135 11351010IESEQ1IEDESCDetailsAtrial Fibrillation CRF C4591001IEC4591001 1139 11391022IESEQ1IEDESCDetailsRecent start of naltrexone for alcohol abuse will defer study CRF C4591001IEC4591001 1139 11391036IESEQ1IEDESCDetailsOngoing sciatica received dexamethasone and will need another dose CRF C4591001IEC4591001 1141 11411002IESEQ1IEDESCDetailsMedication Change CRF C4591001IEC4591001 1141 11411035IESEQ1IEDESCDetailsIncreased CRP, WBC's, ESP CRF C4591001IEC4591001 1142 11421024IESEQ1IEDESCDetailsSubject is currently enrolled on Ebola vaccine trial CRF C4591001IEC4591001 1147 11471002IESEQ1IEDESCDetailsuncontrolled hypertension CRF C4591001IEC4591001 1147 11471005IESEQ1IEDESCDetailssubject screen failed due to uncontrolled hypertension CRF C4591001IEC4591001 1147 11471022IESEQ1IEDESCDetailsscreenfailed due to elevated blood pressures at time of visit CRF C4591001IEC4591001 1147 11471069IESEQ1IEDESCDetailsuncontrolled hypertension CRF C4591001IEC4591001 1147 11471080IESEQ1IEDESCDetailsuncontrolled hypertension CRF C4591001IEC4591001 1147 11471083IESEQ1IEDESCDetailsuncontrolled hypertension CRF C4591001IEC4591001 1147 11471095IESEQ1IEDESCDetailsuncontrolled hypertension CRF C4591001IEC4591001 1147 11471098IESEQ1IEDESCDetailsuncontrolled hypertension CRF C4591001IEC4591001 1147 11471156IESEQ1IEDESCDetailsThe subject received a non-study vaccine 14 days prior to Visit 1 and therefore met delay criteria. The site was no longer enrolling when delay criteria ended. Subject not brought back. CRF C4591001IEC4591001 1147 11471161IESEQ1IEDESCDetailsuncontrolled hypertension CRF C4591001IEC4591001 1147 11471172IESEQ1IEDESCDetailsHBV CRF C4591001IEC4591001 1161 11611002IESEQ1IEDESCDetails(b)(6) CRF C4591001IEC4591001 1161 11611008IESEQ1IEDESCDetailsexclusion #22. (b)(6) CRF C4591001IEC4591001 1161 11611011IESEQ1IEDESCDetails(b)(6) CRF C4591001IEC4591001 1161 11611014IESEQ1IEDESCDetails(b)(6) CRF C4591001IEC4591001 1161 11611018IESEQ1IEDESCDetails(b)(6) CRF C4591001IEC4591001 1161 11611023IESEQ1IEDESCDetailssubject had a medication change, subject has been non responsive to calls for updates to determine if subject was on a previous medication for condition. CRF C4591001IEC4591001 1226 12261109IESEQ1IEDESCDetailsPatient makes use of medication containing corticoid (Alergen) - 5mL QD. CRF C4591001IEC4591001 1226 12261260IESEQ1IEDESCDetailsPatient states that she will not have time to wait for the visit procedures to be carried out. CRF C4591001IEC4591001 1226 12261265IESEQ1IEDESCDetailsPatient informed that he could not wait to continue with all procedures CRF C4591001IEC4591001 1226 12261749IESEQ1IEDESCDetailsThe subject uses Infliximab to treat rheumatoid arthritis CRF C4591001IEC4591001 1226 12261782IESEQ1IEDESCDetailsPatient had a stroke in 2009 and reports that he tends to vascular thrombosis due to homocystinuria disease CRF C4591001IEC4591001 1226 12261804IESEQ1IEDESCDetailsThe subject is in use of a corticosteroid. CRF C4591001IEC4591001 1226 12261808IESEQ1IEDESCDetailsSubject presents pulmonary emphysema, moderate dilated cardiomyopathy and heart failure CRF C4591001IEC4591001 1231 12311048IESEQ1IEDESCDetailsPositive COVID-19 Diagnosis CRF C4591001IEC4591001 1231 12311066IESEQ1IEDESCDetailsmedical decision CRF C4591001IEC4591001 1231 12311066IESEQ2IEDESCDetailshistory of anaphylaxis CRF C4591001IEC4591001 1231 12311066IESEQ3IEDESCDetailshistory of anaphylaxis CRF C4591001IEC4591001 1231 12311086IESEQ1IEDESCDetailsVolunteer declares a suicide attempt a year ago, Therefore, psychiatric medication was required for 6 months. Subject is still under psychiatric follow-up, not taking medication at the moment. CRF C4591001IEC4591001 1231 12311088IESEQ1IEDESCDetailssymptom Probable COVID illness CRF C4591001IEC4591001 1231 12311192IESEQ1IEDESCDetailsMeprednisone 40 mg 3-4 days ago a single dose CRF C4591001IEC4591001 1231 12311305IESEQ1IEDESCDetailsThe patient expressed her desire to get pregnant. CRF C4591001IEC4591001 1231 12311332IESEQ1IEDESCDetailsDiacerein treatment (50mg) ended 8 days ago for osteoarthritis. Can affect immune response. Considered exclusion criteria CRF C4591001IEC4591001 1231 12311345IESEQ1IEDESCDetailsAnaphylaxis to Paracetamol at age 15 CRF C4591001IEC4591001 1231 12311369IESEQ1IEDESCDetailsSubject is not able to comply with all study's instances CRF C4591001IEC4591001 1231 12311378IESEQ1IEDESCDetailsIssued dexamethasone dose 7 days ago due to a seasonal allergy case CRF C4591001IEC4591001 1231 12311406IESEQ1IEDESCDetailsSuicidal thoughts 20 years ago. Depressive Disorder treated w/ Risperidone 10 years ago. Donepezil for Alzheimer and Dementia 8 years ago. Clonazepam 0.5mg a day. Contradicts herself in her speech. CRF C4591001IEC4591001 1231 12311406IESEQ2IEDESCDetailsNo comment CRF C4591001IEC4591001 1231 12311453IESEQ1IEDESCDetailsReceived systemic corticosteroids 48 hours ago CRF C4591001IEC4591001 1231 12311562IESEQ1IEDESCDetailsUnstable chronic pathology. Deterioration of renal function and leukopenia (last month) according to the last and previous laboratory reference. Active allergy due to undetected agent, CRF C4591001IEC4591001 1231 12311622IESEQ1IEDESCDetailsnot applicable CRF C4591001IEC4591001 1231 12311739IESEQ1IEDESCDetailsSplenectomy CRF C4591001IEC4591001 1231 12311805IESEQ1IEDESCDetailsIntramuscular Ibuprofen + Dexamethasone dose 7 days ago due to muscle contracture CRF C4591001IEC4591001 1231 12311867IESEQ1IEDESCDetailsHistory of a severe adverse reaction associated with a vaccine and / or severe allergic reaction (eg, anaphylaxis) to any component of study treatment. CRF C4591001IEC4591001 1231 12311885IESEQ1IEDESCDetailssymptom reported by COVID Disease CRF C4591001IEC4591001 1231 12311902IESEQ1IEDESCDetailsHepatitis B CRF C4591001IEC4591001 1231 12311919IESEQ1IEDESCDetailsSuicidal ideation in February 2020, without a suicide attempt. He requested help, he did not require hospitalization and is in treatment. Borderline personality disorder diagnosed 3 years ago CRF C4591001IEC4591001 1231 12312017IESEQ1IEDESCDetailsSubject reported having taken antidepressant medications, currently without treatment or monitoring. CRF C4591001IEC4591001 1231 12312017IESEQ2IEDESCDetailsPatient refers having had hepatitis at the age of 12 without knowing which type was, and not knowing if he is vaccinated against hepatitis B. CRF C4591001IEC4591001 1231 12312017IESEQ3IEDESCDetailsPatient in dental treatment who received long-term dexamethasone im. CRF C4591001IEC4591001 1231 12312017IESEQ4IEDESCDetailsPatient with dental treatment who received corticosteroid. CRF C4591001IEC4591001 1231 12312099IESEQ1IEDESCDetailsreceived treatment with meprednisone in the last 4 days CRF C4591001IEC4591001 1231 12312147IESEQ1IEDESCDetailsRefers to two episodes of anaphylaxis at age 28. Also refers skin atopy and requirement of daily antihistamines. CRF C4591001IEC4591001 1231 12312189IESEQ1IEDESCDetailsHe had glottis edema and anaphylaxis to amoxicillin in 2018. CRF C4591001IEC4591001 1231 12312222IESEQ1IEDESCDetailsHistory of glottis edema due to administration of sulfonamides. CRF C4591001IEC4591001 1231 12312238IESEQ1IEDESCDetailsSubject had Hepatitis-B 10 years ago. CRF C4591001IEC4591001 1231 12312246IESEQ1IEDESCDetailsHe received treatment with dexamethasone 0.25 mg orally yesterday, he says that he must continue in treatment for 3 days. CRF C4591001IEC4591001 1231 12312353IESEQ1IEDESCDetailsSubject immunocompromised due to Splenectomy CRF C4591001IEC4591001 1231 12312386IESEQ1IEDESCDetailsSubject w/ suicidal thoughts during this year. Reason for excluding from project. CRF C4591001IEC4591001 1231 12312404IESEQ1IEDESCDetailsHe refuses to draw blood. CRF C4591001IEC4591001 1231 12312437IESEQ1IEDESCDetailsCurrently rehabilitated a history of drug addiction.He refers that he has depression and anxiety pictures.Talking about possible side effects made him very anxious.Impression not able to meet visitsCRF C4591001IEC4591001 1231 12312480IESEQ1IEDESCDetailsVolunteer with morbid obesity, a history of alcoholism and smoking, with dyspnea at rest (functional class 4). Presents chronic pathology without clinical stability in the last 6 months. CRF C4591001IEC4591001 1231 12312483IESEQ1IEDESCDetailsReceived Hydroxychloroquine CRF C4591001IEC4591001 1231 12312555IESEQ1IEDESCDetailsHepatitis B positive CRF C4591001IEC4591001 1231 12312736IESEQ1IEDESCDetailsFor facial edama, administration of meloxican, emergency assistance was needed, resolved with intravenous corticosteroids CRF C4591001IEC4591001 1231 12312821IESEQ1IEDESCDetailsHistory of anaphylactic shock due to penicillin administration. He was assisted in intensive therapy CRF C4591001IEC4591001 1231 12312839IESEQ1IEDESCDetailsThe volunteer participates in a study for HIV prevention with antiretroviral medications since 2017 CRF C4591001IEC4591001 1231 12312942IESEQ1IEDESCDetailsPatient with reactivation of Herpes Zoster CRF C4591001IEC4591001 1231 12312942IESEQ2IEDESCDetailsPatient with reactivation of Herpes Zoster on acyclovir treatment 8 days ago CRF C4591001IEC4591001 1231 12312981IESEQ1IEDESCDetailsSevere allergic reaction to tetanus vaccine CRF C4591001IEC4591001 1231 12313142IESEQ1IEDESCDetailschronic bronchitis. CRF C4591001IEC4591001 1231 12313144IESEQ1IEDESCDetailsInjectable corticosteroid 8/5/2020 for L4 L5 discopathy CRF C4591001IEC4591001 1231 12313146IESEQ1IEDESCDetailsHepatitis C diagnosed. CRF C4591001IEC4591001 1231 12313240IESEQ1IEDESCDetailsThe volunteer received intramuscular dexamethasone 3 days ago for low back pain CRF C4591001IEC4591001 1231 12313299IESEQ1IEDESCDetailsPatient was medicated with dexamethasone 10 days ago. CRF C4591001IEC4591001 1231 12313333IESEQ1IEDESCDetailsHe refers to a history of hepatitis C antibodies in a previous laboratory test CRF C4591001IEC4591001 1231 12313341IESEQ1IEDESCDetailsSubject declares anguish due unemplayment. Not controlled by specialist CRF C4591001IEC4591001 1231 12313341IESEQ2IEDESCDetailsIssued Dexamethasone 3mg oral ten days ago due to toothache and implant control. Subject still in dental treatment, therefore will keep recieving this kind of treatment. CRF C4591001IEC4591001 1231 12313373IESEQ1IEDESCDetailsHas a diagnosis of myelodysplastic syndrome from December 2019, currently receives ASS 100 mg per day, presents a risk of bleeding and use of cytotoxic drugs in the near future cannot be excluded CRF C4591001IEC4591001 1231 12313392IESEQ1IEDESCDetailsPatient refers to having had suicidal ideas in the last months and being in treatment CRF C4591001IEC4591001 1231 12313451IESEQ1IEDESCDetailsPatient refers to being on oral dexamethasone treatment for laryngitis CRF C4591001IEC4591001 1241 12411121IESEQ1IEDESCDetailsParticipant was not using any type of contraception, and reports sexual activity. CRF C4591001IEC4591001 1241 12411169IESEQ1IEDESCDetailsInsecure participant to participate in all stages of the study CRF C4591001IEC4591001 1241 12411202IESEQ1IEDESCDetailsParticipant with the human immunodeficiency virus (HIV) CRF C4591001IEC4591001 1241 12411304IESEQ1IEDESCDetailsSubject received systemic corticosteroids CRF C4591001IEC4591001 1241 12411434IESEQ1IEDESCDetailsPsychiatric condition CRF C4591001IEC4591001 1241 12411525IESEQ1IEDESCDetailsHIV positive CRF C4591001IEC4591001 1241 12411533IESEQ1IEDESCDetailsMedical condition CRF C4591001IEC4591001 1241 12411597IESEQ1IEDESCDetailsMedical condition CRF C4591001IEC4591001 1241 12411652IESEQ1IEDESCDetailsMedical condition CRF C4591001IEC4591001 1241 12411737IESEQ1IEDESCDetailsUse of prohibited medication CRF C4591001IEC4591001 1241 12411738IESEQ1IEDESCDetailsMedical condition CRF C4591001IEC4591001 1241 12412011IESEQ1IEDESCDetailsmedical condition CRF