PUB_ID,VISIT,AEPAGENUM,AEDIAG,AESOC,AEMDRA,LL_NAME,HL_NAME,HLG_NAME,AESEVE,AESEVE_TXT,AEREL,AEREL_TXT,AEOUTC,AEOUTCC,AETREATMENT,AEICH,AEICHC,AEDAIDS,AEDAIDSC,AEVISIT,AESAERCT,AESAERCTC,AEONDAY,AEOCDAY
085-059,4,1,sinusitis,Infections and infestations,Sinusitis,Sinusitis,Upper respiratory tract infections,Infections - pathogen unspecified,2,Moderate,2,Not Related,5,Continuing at End of Study,Medication,2,No,2,No,4,2,No,98,
085-002,2,1,lightheaded,Nervous system disorders,Dizziness,Lightheadedness,Neurological signs and symptoms NEC,Neurological disorders NEC,1,Mild,1,Related,2,Resolved,None,2,No,2,No,2,2,No,0,0
085-002,2,2,tingling in fingers of both hands,Nervous system disorders,Paraesthesia,Tingling of extremity,Paraesthesias and dysaesthesias,Neurological disorders NEC,1,Mild,1,Related,2,Resolved,None,2,No,2,No,2,2,No,0,0
085-002,2,3,dizziness,Nervous system disorders,Dizziness,Dizziness,Neurological signs and symptoms NEC,Neurological disorders NEC,1,Mild,1,Related,2,Resolved,None,2,No,2,No,2,2,No,0,0
085-002,4,4,low back strain,"Injury, poisoning and procedural complications",Muscle strain,Muscle strain,"Muscle, tendon and ligament injuries",Injuries NEC,1,Mild,2,Not Related,2,Resolved,"Medication, Other",2,No,2,No,4,2,No,70,92
085-001,4,2,abcess - left inner thigh -related to ingrown hair,Skin and subcutaneous tissue disorders,Ingrown hair,Ingrown hair,Pilar disorders NEC,Skin appendage conditions,1,Mild,2,Not Related,2,Resolved,Medication,2,No,2,No,4,2,No,99,145
085-005,5,2,canker sore right soft palate,Gastrointestinal disorders,Aphthous stomatitis,Canker sores oral,Stomatitis and ulceration,Oral soft tissue conditions,1,Mild,2,Not Related,5,Continuing at End of Study,None,2,No,2,No,5,2,No,177,
085-006,4,1,upper respiratory infection,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,1,Mild,2,Not Related,2,Resolved,Medication,2,No,2,No,4,2,No,93,100
085-007,2,1,abdominal pain,Gastrointestinal disorders,Abdominal pain,Abdominal pain,Gastrointestinal and abdominal pains (excl oral and throat),Gastrointestinal signs and symptoms,1,Mild,1,Related,2,Resolved,None,2,No,2,No,2,2,No,1,3
085-007,3,2,fatigue,General disorders and administration site conditions,Fatigue,Fatigue,Asthenic conditions,General system disorders NEC,1,Mild,2,Not Related,2,Resolved,None,2,No,2,No,3,2,No,25,27
085-011,3,1,upper respiratory infection,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,1,Mild,2,Not Related,2,Resolved,Medication,2,No,2,No,3,2,No,18,27
085-012,3,1,upper respiratory infection,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,1,Mild,2,Not Related,2,Resolved,Medication,2,No,2,No,3,2,No,26,30
085-013,4,1,pain - upper and lower jaw related to wisdom te...,"Injury, poisoning and procedural complications",Procedural pain,Post procedural pain,Non-site specific procedural complications,Procedural related injuries and complications NEC,2,Moderate,2,Not Related,2,Resolved,Medication,2,No,2,No,4,2,No,125,128
085-017,2,1,nausea - intermittent,Gastrointestinal disorders,Nausea,Nausea,Nausea and vomiting symptoms,Gastrointestinal signs and symptoms,1,Mild,2,Not Related,2,Resolved,None,2,No,2,No,2,2,No,5,7
085-017,2,2,fatigue,General disorders and administration site conditions,Fatigue,Fatigue,Asthenic conditions,General system disorders NEC,1,Mild,2,Not Related,2,Resolved,None,2,No,2,No,2,2,No,7,7
085-016,3,1,pneumonia,Infections and infestations,Pneumonia,Pneumonia,Lower respiratory tract and lung infections,Infections - pathogen unspecified,1,Mild,2,Not Related,2,Resolved,Medication,2,No,2,No,3,2,No,7,47
085-021,3,1,cat scratch,"Injury, poisoning and procedural complications",Animal scratch,Cat scratch,Non-site specific injuries NEC,Injuries NEC,1,Mild,2,Not Related,2,Resolved,Medication,2,No,2,No,3,2,No,31,31
085-021,4,2,viral syndrome,Infections and infestations,Viral infection,Viral syndrome,Viral infections NEC,Viral infectious disorders,2,Moderate,2,Not Related,2,Resolved,Medication,2,No,2,No,4,2,No,54,70
085-021,4,3,elevated alt,Investigations,Alanine aminotransferase increased,ALT increased,Liver function analyses,Hepatobiliary investigations,1,Mild,2,Not Related,4,Severity/Frequency,None,2,No,2,No,4,2,No,70,116
085-021,4,4,elevated ast,Investigations,Aspartate aminotransferase increased,AST increased,Liver function analyses,Hepatobiliary investigations,1,Mild,2,Not Related,2,Resolved,None,2,No,2,No,4,2,No,70,77
085-021,4,5,elevated AST,Investigations,Aspartate aminotransferase increased,AST increased,Liver function analyses,Hepatobiliary investigations,1,Mild,2,Not Related,4,Severity/Frequency,None,2,No,2,No,4,2,No,116,186
085-021,4,6,elevated ALT,Investigations,Alanine aminotransferase increased,ALT increased,Liver function analyses,Hepatobiliary investigations,2,Moderate,2,Not Related,5,Continuing at End of Study,None,2,No,2,No,4,2,No,116,
085-021,5,7,elevated AST,Investigations,Aspartate aminotransferase increased,AST increased,Liver function analyses,Hepatobiliary investigations,2,Moderate,2,Not Related,5,Continuing at End of Study,None,2,No,2,No,5,2,No,186,
085-025,4,1,heat rash,Skin and subcutaneous tissue disorders,Heat rash,Heat rash,Apocrine and eccrine gland disorders,Skin appendage conditions,1,Mild,2,Not Related,2,Resolved,Medication,2,No,2,No,4,2,No,70,70
085-030,3,1,bilat tenderness at deltoid injection sites,General disorders and administration site conditions,Injection site pain,Injection site tenderness,Injection site reactions,Administration site reactions,1,Mild,1,Related,2,Resolved,None,2,No,2,No,3,2,No,8,10
085-030,3,2,bilat pain at thigh injection sites,General disorders and administration site conditions,Injection site pain,Injection site pain,Injection site reactions,Administration site reactions,1,Mild,1,Related,2,Resolved,None,2,No,2,No,3,2,No,8,10
085-027,4,1,nausea,Gastrointestinal disorders,Nausea,Nausea,Nausea and vomiting symptoms,Gastrointestinal signs and symptoms,1,Mild,2,Not Related,2,Resolved,None,2,No,2,No,4,2,No,111,112
085-031,2,1,right arm tingling[tingling of arm post injection],Nervous system disorders,Paraesthesia,Tingling of extremity,Paraesthesias and dysaesthesias,Neurological disorders NEC,1,Mild,1,Related,2,Resolved,None,2,No,2,No,2,2,No,0,0
085-031,2,2,dizziness,Nervous system disorders,Dizziness,Dizziness,Neurological signs and symptoms NEC,Neurological disorders NEC,1,Mild,1,Related,2,Resolved,None,2,No,2,No,2,2,No,0,0
085-031,4,3,vertigo (related to side effect of viibryd),General disorders and administration site conditions,Adverse drug reaction,Adverse drug reaction,Therapeutic and nontherapeutic responses,Therapeutic and nontherapeutic effects (excl toxicity),1,Mild,2,Not Related,2,Resolved,Medication,2,No,2,No,4,2,No,40,47
085-031,5,4,anemia,Blood and lymphatic system disorders,Anaemia,Anemia,Anaemias NEC,Anaemias nonhaemolytic and marrow depression,1,Mild,2,Not Related,5,Continuing at End of Study,Other,2,No,2,No,5,2,No,201,
085-038,5,1,nasal congestion,"Respiratory, thoracic and mediastinal disorders",Nasal congestion,Nasal congestion,Nasal congestion and inflammations,Upper respiratory tract disorders (excl infections),1,Mild,2,Not Related,2,Resolved,Medication,2,No,2,No,5,2,No,189,190
085-035,5,1,Fever,General disorders and administration site conditions,Pyrexia,Fever,Febrile disorders,Body temperature conditions,1,Mild,2,Not Related,2,Resolved,Medication,2,No,2,No,5,2,No,170,175
085-035,5,2,URI,Infections and infestations,Upper respiratory tract infection,URTI (upper respiratory tract infection),Upper respiratory tract infections,Infections - pathogen unspecified,1,Mild,2,Not Related,2,Resolved,None,2,No,2,No,5,2,No,196,205
085-045,2,1,"""warmth"" at right deltoid injection site",General disorders and administration site conditions,Injection site warmth,Injection site warmth,Injection site reactions,Administration site reactions,1,Mild,1,Related,2,Resolved,None,2,No,2,No,2,2,No,8,8
085-045,2,2,pain at right deltoid injection site,General disorders and administration site conditions,Injection site pain,Injection site pain,Injection site reactions,Administration site reactions,1,Mild,1,Related,2,Resolved,None,2,No,2,No,2,2,No,8,11
085-045,2,3,tenderness at right deltoid injection site,General disorders and administration site conditions,Injection site pain,Injection site tenderness,Injection site reactions,Administration site reactions,1,Mild,1,Related,2,Resolved,None,2,No,2,No,2,2,No,8,11
085-045,3,4,night sweats,Skin and subcutaneous tissue disorders,Night sweats,Night sweats,Apocrine and eccrine gland disorders,Skin appendage conditions,1,Mild,2,Not Related,2,Resolved,None,2,No,2,No,3,2,No,18,18
085-045,5,5,uri,Infections and infestations,Upper respiratory tract infection,URTI (upper respiratory tract infection),Upper respiratory tract infections,Infections - pathogen unspecified,1,Mild,2,Not Related,2,Resolved,None,2,No,2,No,5,2,No,171,178
085-046,3,1,nasal congestion,"Respiratory, thoracic and mediastinal disorders",Nasal congestion,Nasal congestion,Nasal congestion and inflammations,Upper respiratory tract disorders (excl infections),1,Mild,2,Not Related,2,Resolved,Medication,2,No,2,No,3,2,No,21,24
085-046,4,2,dental pain related to impacted wisdom teeth,Gastrointestinal disorders,Tooth impacted,Impacted wisdom tooth,Dental disorders NEC,Dental and gingival conditions,2,Moderate,2,Not Related,2,Resolved,"Medication, Procedure/Surgery",2,No,2,No,4,2,No,106,110
085-046,5,3,bilat. mid back pain,Musculoskeletal and connective tissue disorders,Back pain,Back pain,Musculoskeletal and connective tissue pain and discomfort,Musculoskeletal and connective tissue disorders NEC,1,Mild,2,Not Related,5,Continuing at End of Study,None,2,No,2,No,5,2,No,86,
085-056,4,1,dyspepsia (related to taking aleve),General disorders and administration site conditions,Adverse drug reaction,Adverse drug reaction,Therapeutic and nontherapeutic responses,Therapeutic and nontherapeutic effects (excl toxicity),1,Mild,2,Not Related,2,Resolved,Medication,2,No,2,No,4,2,No,92,116
085-067,4,1,uterine fibroids,"Neoplasms benign, malignant and unspecified (incl cysts and polyps)",Uterine leiomyoma,Uterine fibroids,Uterine neoplasms benign,Reproductive neoplasms female benign,1,Mild,2,Not Related,2,Resolved,"Medication, Procedure/Surgery",2,No,2,No,4,2,No,88,139
085-067,4,2,uterine polyps,Reproductive system and breast disorders,Uterine polyp,Uterine polyp,Uterine neoplasms,"Uterine, pelvic and broad ligament disorders",1,Mild,2,Not Related,2,Resolved,"Medication, Procedure/Surgery",2,No,2,No,4,2,No,109,139
085-069,3,1,uri,Infections and infestations,Upper respiratory tract infection,URTI (upper respiratory tract infection),Upper respiratory tract infections,Infections - pathogen unspecified,1,Mild,2,Not Related,2,Resolved,None,2,No,2,No,3,2,No,8,34
085-075,3,1,URI,Infections and infestations,Upper respiratory tract infection,URTI (upper respiratory tract infection),Upper respiratory tract infections,Infections - pathogen unspecified,1,Mild,2,Not Related,2,Resolved,None,2,No,2,No,3,2,No,32,36
085-075,5,2,seasonal allergy,Immune system disorders,Seasonal allergy,Seasonal allergy,Atopic disorders,Allergic conditions,2,Moderate,2,Not Related,5,Continuing at End of Study,Medication,2,No,2,No,5,2,No,178,
085-009,2.1,1,diarrhea,Gastrointestinal disorders,Diarrhoea,Diarrhea,Diarrhoea (excl infective),Gastrointestinal motility and defaecation conditions,2,Moderate,2,Not Related,2,Resolved,Medication,2,No,2,No,2.1,2,No,5,8
085-009,2.1,2,malaise,General disorders and administration site conditions,Malaise,Malaise,Asthenic conditions,General system disorders NEC,1,Mild,2,Not Related,2,Resolved,None,2,No,2,No,2.1,2,No,5,6
085-009,2.1,3,elevated blood pressure,Investigations,Blood pressure increased,Blood pressure increased,Vascular tests NEC (incl blood pressure),Cardiac and vascular investigations (excl enzyme tests),2,Moderate,2,Not Related,2,Resolved,Medication,2,No,2,No,2.1,2,No,6,189
085-009,4.1,4,decreased grip strength: right arm,Investigations,Grip strength decreased,Grip strength decreased,Physical examination procedures and organ system status,Physical examination and organ system status topics,1,Mild,2,Not Related,2,Resolved,None,2,No,2,No,4.1,2,No,107,136
085-009,5,5,upper respiratory infection,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,1,Mild,2,Not Related,5,Continuing at End of Study,None,2,No,2,No,5,2,No,187,
085-018,3,1,panic attack,Psychiatric disorders,Panic attack,Panic attack,Panic attacks and disorders,Anxiety disorders and symptoms,2,Moderate,2,Not Related,2,Resolved,"Medication, Other",2,No,2,No,3,2,No,0,5
085-018,3,2,upper respiratory infection,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,1,Mild,2,Not Related,2,Resolved,Medication,2,No,2,No,3,2,No,24,31
085-018,5,3,right elbow tendonitis,Musculoskeletal and connective tissue disorders,Tendonitis,Tendonitis,Tendon disorders,"Tendon, ligament and cartilage disorders",2,Moderate,2,Not Related,5,Continuing at End of Study,Other,2,No,2,No,5,2,No,142,
085-033,4,1,upper respiratory infection,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,1,Mild,2,Not Related,2,Resolved,Medication,2,No,2,No,4,2,No,100,100
085-033,5,2,bilateral tonsilar enlargement,"Respiratory, thoracic and mediastinal disorders",Tonsillar hypertrophy,Enlarged tonsils,Pharyngeal disorders (excl infections and neoplasms),Upper respiratory tract disorders (excl infections),1,Mild,2,Not Related,5,Continuing at End of Study,None,2,No,2,No,5,2,No,188,
085-032,5,1,upper respiratory infection - viral,Infections and infestations,Viral upper respiratory tract infection,Viral upper respiratory tract infection,Viral infections NEC,Viral infectious disorders,1,Mild,2,Not Related,2,Resolved,Medication,2,No,2,No,5,2,No,140,140
085-043,3.1,1,right tibial plateau fracture,"Injury, poisoning and procedural complications",Tibia fracture,Tibia fracture,Lower limb fractures and dislocations,Bone and joint injuries,4,Potentially life-threatening,2,Not Related,5,Continuing at End of Study,"Medication, New/Prolonged Hospitalization, Procedure/Surgery",1,Yes,1,Yes,3.1,2,No,79,
085-043,3.1,2,dysphagia-side effect from pain medication,General disorders and administration site conditions,Adverse drug reaction,Adverse drug reaction,Therapeutic and nontherapeutic responses,Therapeutic and nontherapeutic effects (excl toxicity),2,Moderate,2,Not Related,2,Resolved,None,2,No,2,No,3.1,2,No,110,114
085-043,3.1,3,anemia,Blood and lymphatic system disorders,Anaemia,Anemia,Anaemias NEC,Anaemias nonhaemolytic and marrow depression,2,Moderate,2,Not Related,4,Severity/Frequency,None,2,No,2,No,3.1,2,No,80,98
085-043,3.1,4,anemia,Blood and lymphatic system disorders,Anaemia,Anemia,Anaemias NEC,Anaemias nonhaemolytic and marrow depression,3,Severe,2,Not Related,4,Severity/Frequency,None,2,No,2,No,3.1,2,No,98,99
085-043,3.1,5,anemia,Blood and lymphatic system disorders,Anaemia,Anemia,Anaemias NEC,Anaemias nonhaemolytic and marrow depression,4,Potentially life-threatening,2,Not Related,2,Resolved,Medication,2,No,2,No,3.1,2,No,99,175
085-043,4,6,unintentional weight loss-related to leg fracture,"Injury, poisoning and procedural complications",Lower limb fracture,Leg fracture,Lower limb fractures and dislocations,Bone and joint injuries,4,Potentially life-threatening,2,Not Related,5,Continuing at End of Study,None,2,No,2,No,4,2,No,130,
085-051,5,1,upper respiratory infection - viral etiology,Infections and infestations,Viral upper respiratory tract infection,Viral upper respiratory tract infection,Viral infections NEC,Viral infectious disorders,1,Mild,2,Not Related,2,Resolved,None,2,No,2,No,5,2,No,169,169
085-051,5,2,vaginal candidiasis,Infections and infestations,Vulvovaginal candidiasis,Vulvovaginal candidiasis,Candida infections,Fungal infectious disorders,2,Moderate,2,Not Related,2,Resolved,Medication,2,No,2,No,5,2,No,138,138
085-058,4,1,upper respiratory infection-viral,Infections and infestations,Viral upper respiratory tract infection,Viral upper respiratory tract infection,Viral infections NEC,Viral infectious disorders,1,Mild,2,Not Related,2,Resolved,None,2,No,2,No,4,2,No,87,117
085-050,4.1,1,streptococcal pharnyngitis,Infections and infestations,Pharyngitis streptococcal,Streptococcal pharyngitis,Streptococcal infections,Bacterial infectious disorders,2,Moderate,2,Not Related,2,Resolved,None,2,No,2,No,4.1,2,No,119,122
085-050,4.1,2,right back muscle spasm,Musculoskeletal and connective tissue disorders,Muscle spasms,Back muscle spasms,Muscle related signs and symptoms NEC,Muscle disorders,2,Moderate,2,Not Related,2,Resolved,Medication,2,No,2,No,4.1,2,No,122,160
085-050,4.2,3,appendicitis,Infections and infestations,Appendicitis,Appendicitis,Abdominal and gastrointestinal infections,Infections - pathogen unspecified,3,Severe,2,Not Related,2,Resolved,"New/Prolonged Hospitalization, Procedure/Surgery",1,Yes,1,Yes,4.2,2,No,146,148
085-050,4.3,4,streptococcal pharyngitis,Infections and infestations,Pharyngitis streptococcal,Streptococcal pharyngitis,Streptococcal infections,Bacterial infectious disorders,2,Moderate,2,Not Related,2,Resolved,Medication,2,No,2,No,4.3,2,No,175,168
085-050,4.3,5,group a streptococcal vaginitis,Infections and infestations,Vulvovaginitis streptococcal,Vulvovaginitis streptococcal,Streptococcal infections,Bacterial infectious disorders,2,Moderate,2,Not Related,2,Resolved,Medication,2,No,2,No,4.3,2,No,178,197
085-050,4.4,6,streptococcal pharyngitis,Infections and infestations,Pharyngitis streptococcal,Streptococcal pharyngitis,Streptococcal infections,Bacterial infectious disorders,2,Moderate,2,Not Related,2,Resolved,Medication,2,No,2,No,4.4,2,No,193,199
085-065,3,1,upper respiratory infection,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,1,Mild,2,Not Related,2,Resolved,None,2,No,2,No,3,2,No,24,38
085-065,4,2,nasal congestion,"Respiratory, thoracic and mediastinal disorders",Nasal congestion,Nasal congestion,Nasal congestion and inflammations,Upper respiratory tract disorders (excl infections),1,Mild,2,Not Related,2,Resolved,None,2,No,2,No,4,2,No,99,99
085-019,2.1,1,mild ache injection site right thigh,General disorders and administration site conditions,Injection site pain,Injection site pain,Injection site reactions,Administration site reactions,1,Mild,1,Related,2,Resolved,None,2,No,2,No,2.1,2,No,8,29
085-019,2.1,2,mild ache injection site left thigh,General disorders and administration site conditions,Injection site pain,Injection site pain,Injection site reactions,Administration site reactions,1,Mild,1,Related,2,Resolved,None,2,No,2,No,2.1,2,No,8,29
085-019,2.1,3,right deltoid ache at injection site,General disorders and administration site conditions,Injection site pain,Injection site pain,Injection site reactions,Administration site reactions,1,Mild,1,Related,2,Resolved,None,2,No,2,No,2.1,2,No,9,29
085-019,2.1,4,mild ache left deltoid at inj. site,General disorders and administration site conditions,Injection site pain,Injection site pain,Injection site reactions,Administration site reactions,1,Mild,1,Related,2,Resolved,None,2,No,2,No,2.1,2,No,9,29
085-019,2.1,5,induration at injection site - right deltoid,General disorders and administration site conditions,Injection site induration,Injection site induration,Injection site reactions,Administration site reactions,1,Mild,1,Related,2,Resolved,None,2,No,2,No,2.1,2,No,9,29
085-019,5.1,6,viral illness,Infections and infestations,Viral infection,Viral infection,Viral infections NEC,Viral infectious disorders,2,Moderate,2,Not Related,2,Resolved,None,2,No,2,No,5.1,2,No,194,199
085-023,4,2,hyper sensitivity to nitrofurantoin,Immune system disorders,Drug hypersensitivity,Drug hypersensitivity,"Allergies to foods, food additives, drugs and other chemicals",Allergic conditions,3,Severe,2,Not Related,2,Resolved,Medication,2,No,2,No,4,2,No,71,117
085-023,4,3,impacted wisdom teeth,Gastrointestinal disorders,Tooth impacted,Impacted wisdom tooth,Dental disorders NEC,Dental and gingival conditions,2,Moderate,2,Not Related,2,Resolved,Medication,2,No,2,No,4,2,No,105,105
085-020,3,1,URI,Infections and infestations,Upper respiratory tract infection,Upper respiratory tract infection,Upper respiratory tract infections,Infections - pathogen unspecified,1,Mild,2,Not Related,2,Resolved,Medication,2,No,2,No,3,2,No,13,16
085-020,4,2,Hot tub folliculitis,Infections and infestations,Folliculitis,Folliculitis,Bacterial infections NEC,Bacterial infectious disorders,2,Moderate,2,Not Related,2,Resolved,Medication,2,No,2,No,4,2,No,129,143
085-020,4,3,Viral pharyngitis,Infections and infestations,Viral pharyngitis,Viral pharyngitis,Viral infections NEC,Viral infectious disorders,1,Mild,2,Not Related,2,Resolved,Medication,2,No,2,No,4,2,No,114,116
085-053,4,2,URI,Infections and infestations,Upper respiratory tract infection,Upper respiratory tract infection,Upper respiratory tract infections,Infections - pathogen unspecified,1,Mild,2,Not Related,2,Resolved,Medication,2,No,2,No,4,2,No,98,102
085-053,5,3,uti,Infections and infestations,Urinary tract infection,UTI,Urinary tract infections,Infections - pathogen unspecified,1,Mild,2,Not Related,2,Resolved,Medication,2,No,2,No,5,2,No,204,207
085-055,4,1,URI,Infections and infestations,Upper respiratory tract infection,URTI (upper respiratory tract infection),Upper respiratory tract infections,Infections - pathogen unspecified,1,Mild,2,Not Related,2,Resolved,Medication,2,No,2,No,4,2,No,22,28
085-055,4,2,scabies,Infections and infestations,Acarodermatitis,Scabies,Ectoparasitic infestations,Ectoparasitic disorders,1,Mild,2,Not Related,5,Continuing at End of Study,"Medication, Other",2,No,2,No,4,2,No,98,
085-062,3,1,left ankle sprain,"Injury, poisoning and procedural complications",Ligament sprain,Ankle sprain,"Muscle, tendon and ligament injuries",Injuries NEC,2,Moderate,2,Not Related,2,Resolved,Medication,2,No,2,No,3,2,No,19,49
085-063,2.1,1,bruise at injection site,General disorders and administration site conditions,Injection site bruising,Injection site bruising,Injection site reactions,Administration site reactions,1,Mild,2,Not Related,2,Resolved,None,2,No,2,No,2.1,2,No,0,10
085-063,2.2,3,induration - right thigh (skin),Skin and subcutaneous tissue disorders,Skin induration,Skin induration,Dermal and epidermal conditions NEC,Epidermal and dermal conditions,1,Mild,1,Related,2,Resolved,Other,2,No,2,No,2.2,2,No,10,17
085-063,2.2,4,erythema - right thigh,Skin and subcutaneous tissue disorders,Erythema,Skin erythema,Erythemas,Epidermal and dermal conditions,1,Mild,1,Related,2,Resolved,Other,2,No,2,No,2.2,2,No,10,12
085-063,3,6,headache,Nervous system disorders,Headache,Headache,Headaches NEC,Headaches,1,Mild,2,Not Related,2,Resolved,Medication,2,No,2,No,3,2,No,25,26
085-072,4,1,infected right upper molar,Infections and infestations,Tooth infection,Tooth infection,Dental and oral soft tissue infections,Infections - pathogen unspecified,1,Mild,2,Not Related,2,Resolved,Medication,2,No,2,No,4,2,No,89,117
085-072,4.1,4,bradycardia,Cardiac disorders,Bradycardia,Bradycardia,Rate and rhythm disorders NEC,Cardiac arrhythmias,3,Severe,2,Not Related,2,Resolved,None,2,No,2,No,4.1,2,No,185,187
085-072,4.1,5,benign positional vertigo (bpv),Ear and labyrinth disorders,Vertigo positional,Benign positional vertigo,Inner ear signs and symptoms,Inner ear and VIIIth cranial nerve disorders,1,Mild,2,Not Related,2,Resolved,Other,2,No,2,No,4.1,2,No,184,185
085-081,3,2,right thigh induration,General disorders and administration site conditions,Induration,Induration,General signs and symptoms NEC,General system disorders NEC,1,Mild,1,Related,2,Resolved,None,2,No,2,No,3,2,No,8,13
085-081,3,3,exudative pharyngitis,"Respiratory, thoracic and mediastinal disorders",Pharyngeal exudate,Pharyngeal exudate,Pharyngeal disorders (excl infections and neoplasms),Upper respiratory tract disorders (excl infections),2,Moderate,2,Not Related,2,Resolved,Medication,2,No,2,No,3,2,No,7,15
085-081,3,4,uri,Infections and infestations,Upper respiratory tract infection,URTI (upper respiratory tract infection),Upper respiratory tract infections,Infections - pathogen unspecified,1,Mild,2,Not Related,2,Resolved,Medication,2,No,2,No,3,2,No,16,19
085-081,3,5,right hand laceration,"Injury, poisoning and procedural complications",Laceration,Laceration of hand,Skin injuries NEC,Injuries NEC,1,Mild,2,Not Related,2,Resolved,Medication,2,No,2,No,3,2,No,27,35
085-073,2.1,2,upper respiratory viral illness,Infections and infestations,Viral upper respiratory tract infection,Viral upper respiratory tract infection,Viral infections NEC,Viral infectious disorders,2,Moderate,2,Not Related,2,Resolved,None,2,No,2,No,2.1,2,No,4,22
085-073,4,3,dental caries,Gastrointestinal disorders,Dental caries,Dental caries,Dental and periodontal infections and inflammations,Dental and gingival conditions,3,Severe,2,Not Related,5,Continuing at End of Study,Medication,2,No,2,No,4,2,No,99,
085-070,5,1,scabies,Infections and infestations,Acarodermatitis,Scabies,Ectoparasitic infestations,Ectoparasitic disorders,2,Moderate,2,Not Related,2,Resolved,Medication,2,No,2,No,5,2,No,150,159
085-028,3,1,dental abscess,Infections and infestations,Tooth abscess,Dental abscess,Dental and oral soft tissue infections,Infections - pathogen unspecified,1,Mild,2,Not Related,2,Resolved,Medication,2,No,2,No,3,2,No,20,39
085-040,3,1,bacterial vaginosis,Infections and infestations,Vaginitis bacterial,Bacterial vaginosis,Bacterial infections NEC,Bacterial infectious disorders,1,Mild,2,Not Related,5,Continuing at End of Study,Medication,2,No,2,No,3,2,No,21,
085-079,2,1,paresthesias - right hand,Nervous system disorders,Paraesthesia,Paresthesia hand,Paraesthesias and dysaesthesias,Neurological disorders NEC,1,Mild,1,Related,2,Resolved,None,2,No,2,No,2,2,No,7,69
085-079,2,2,pain - right deltoid,Musculoskeletal and connective tissue disorders,Pain in extremity,Pain in arm,Musculoskeletal and connective tissue pain and discomfort,Musculoskeletal and connective tissue disorders NEC,2,Moderate,1,Related,5,Continuing at End of Study,None,2,No,2,No,2,2,No,8,
085-079,4,3,viral upper respiratory tract infection,Infections and infestations,Viral upper respiratory tract infection,Viral upper respiratory tract infection,Viral infections NEC,Viral infectious disorders,1,Mild,2,Not Related,2,Resolved,Medication,2,No,2,No,4,2,No,80,82
085-079,4.1,4,neck pain,Musculoskeletal and connective tissue disorders,Neck pain,Neck pain,Musculoskeletal and connective tissue pain and discomfort,Musculoskeletal and connective tissue disorders NEC,1,Mild,2,Not Related,5,Continuing at End of Study,None,2,No,2,No,4.1,2,No,154,
085-089,4,1,gastroenteritis,Infections and infestations,Gastroenteritis,Gastroenteritis,Abdominal and gastrointestinal infections,Infections - pathogen unspecified,2,Moderate,2,Not Related,2,Resolved,None,2,No,2,No,4,2,No,82,84