AESEQ,AEDIAG,AESOC,AEMDRA,AEMDVER,LL_NAME,HL_NAME,HLG_NAME,AEVISIT,AESEVE,AESEVE_TXT,AEREL,AETREATMENT,AEOUTCC,AEICHC,AEDAIDSC,AESAERCTC,AEDRAD,AEDRADC,RX_CODE,RX_LABEL,PUB_ID
1,Hematuria,Renal and urinary disorders,Haematuria,,Hematuria,Urinary abnormalities,Urinary tract signs and symptoms,5,Moderate,Grade 2 (Moderate),Not Related,None,Resolved,No,No,No,1,IV,T2,PGDM1400 + VRC07-523LS mo 0,130-02
2,Elevated ALT,Investigations,Alanine aminotransferase increased,,ALT increased,Liver function analyses,Hepatobiliary investigations,9,Mild,Grade 1 (Mild),Not Related,None,Continuing at last scheduled clinic visit,No,No,No,1,IV,T2,PGDM1400 + VRC07-523LS mo 0,130-02
3,Respiratory Distress,"Respiratory, thoracic and mediastinal disorders",Respiratory distress,,Respiratory distress,Breathing abnormalities,Respiratory disorders NEC,9.2,Death,Grade 5 (Death),Not Related,Medication,Death,Yes,Yes,No,1,IV,T2,PGDM1400 + VRC07-523LS mo 0,130-02
1,decreased absolute lymphocyte count,Investigations,Lymphocyte count decreased,,Absolute lymphocyte count decreased,White blood cell analyses,Haematology investigations (incl blood groups),5,Moderate,Grade 2 (Moderate),Not Related,None,Resolved,No,No,No,1,IV,T4,"PGT121 + PGDM1400 + VRC07-523LS mo (0, 4)",130-03
2,pain post tooth extraction,"Injury, poisoning and procedural complications",Procedural pain,,Post procedural pain,Non-site specific procedural complications,Procedural related injuries and complications NEC,8,Moderate,Grade 2 (Moderate),Not Related,Medication,Resolved,No,No,No,1,IV,T4,"PGT121 + PGDM1400 + VRC07-523LS mo (0, 4)",130-03
3,asymptomatic oropharyngeal chlamydia,Infections and infestations,Pharyngeal chlamydia infection,,Pharyngeal chlamydia infection,Chlamydial infections,Chlamydial infectious disorders,13,Moderate,Grade 2 (Moderate),Not Related,Other: med prescribed will start asap,Continuing at last scheduled clinic visit,No,No,No,1,IV,T4,"PGT121 + PGDM1400 + VRC07-523LS mo (0, 4)",130-03
4,Depression,Psychiatric disorders,Depression,,Depression,Depressive disorders,Depressed mood disorders and disturbances,14,Mild,Grade 1 (Mild),Not Related,Other: Therapy,Continuing at last scheduled clinic visit,No,No,No,1,IV,T4,"PGT121 + PGDM1400 + VRC07-523LS mo (0, 4)",130-03
1,"tingling, bilateral hands",Nervous system disorders,Paraesthesia,,Paraesthesia hand,Paraesthesias and dysaesthesias,Neurological disorders NEC,3,Mild,Grade 1 (Mild),Related,None,Resolved,No,No,No,1,IV,T3,10-1074 + VRC07-523LS mo 0,130-05
2,non productive cough,"Respiratory, thoracic and mediastinal disorders",Cough,,Cough nonproductive,Coughing and associated symptoms,Respiratory disorders NEC,4,Mild,Grade 1 (Mild),Not Related,Medication,Resolved,No,No,No,1,IV,T3,10-1074 + VRC07-523LS mo 0,130-05
3,"platelets, low",Investigations,Platelet count decreased,,Low platelets,Platelet analyses,Haematology investigations (incl blood groups),5,Mild,Grade 1 (Mild),Not Related,None,Resolved,No,No,No,1,IV,T3,10-1074 + VRC07-523LS mo 0,130-05
4,"hemoglobin, low",Investigations,Haemoglobin decreased,,Hemoglobin low,Red blood cell analyses,Haematology investigations (incl blood groups),5,Mild,Grade 1 (Mild),Not Related,None,Resolved,No,No,No,1,IV,T3,10-1074 + VRC07-523LS mo 0,130-05
5,nonproductive cough,"Respiratory, thoracic and mediastinal disorders",Cough,,Cough nonproductive,Coughing and associated symptoms,Respiratory disorders NEC,7,Mild,Grade 1 (Mild),Not Related,Medication,Resolved,No,No,No,1,IV,T3,10-1074 + VRC07-523LS mo 0,130-05
6,"platelets, low",Investigations,Platelet count decreased,,Low platelets,Platelet analyses,Haematology investigations (incl blood groups),13,Mild,Grade 1 (Mild),Not Related,None,Continuing at last scheduled clinic visit,No,No,No,1,IV,T3,10-1074 + VRC07-523LS mo 0,130-05
1,COVID-19,Infections and infestations,COVID-19,,COVID-19,Coronavirus infections,Viral infectious disorders,12,Moderate,Grade 2 (Moderate),Not Related,None,Resolved,No,No,No,1,IV,T2,PGDM1400 + VRC07-523LS mo 0,130-06
1,Proteinuria,Renal and urinary disorders,Proteinuria,,Proteinuria,Urinary abnormalities,Urinary tract signs and symptoms,5,Mild,Grade 1 (Mild),Not Related,None,Resolved,No,No,No,1,IV,T3,10-1074 + VRC07-523LS mo 0,130-07
2,Burn on back of right hand,"Injury, poisoning and procedural complications",Thermal burn,,Burn of unspecified degree of back of hand,Thermal burns,Injuries by physical agents,13,Moderate,Grade 2 (Moderate),Not Related,None,Resolved,No,No,No,1,IV,T3,10-1074 + VRC07-523LS mo 0,130-07
1,Infiltration at IV site - right arm,General disorders and administration site conditions,Infusion site extravasation,,Infusion site infiltration,Infusion site reactions,Administration site reactions,2,Moderate,Grade 2 (Moderate),Not Related,Other: Stopping IV and applying warm pack.,Resolved,No,No,No,1,IV,T3,10-1074 + VRC07-523LS mo 0,130-08
2,Mosquito bites,"Injury, poisoning and procedural complications",Arthropod bite,,Mosquito bite,Non-site specific injuries NEC,Injuries NEC,3,Mild,Grade 1 (Mild),Not Related,None,Resolved,No,No,No,1,IV,T3,10-1074 + VRC07-523LS mo 0,130-08
1,Decreased platelets,Investigations,Platelet count decreased,,Platelets decreased,Platelet analyses,Haematology investigations (incl blood groups),7,Mild,Grade 1 (Mild),Not Related,None,Severity/frequency increased,No,No,No,1,IV,T1,PGT121 + VRC07-523LS mo 0,130-11
2,Decreased platelets,Investigations,Platelet count decreased,,Platelets decreased,Platelet analyses,Haematology investigations (incl blood groups),9,Moderate,Grade 2 (Moderate),Not Related,None,Resolved,No,No,No,1,IV,T1,PGT121 + VRC07-523LS mo 0,130-11
3,Decrease platelets,Investigations,Platelet count decreased,,Platelets decreased,Platelet analyses,Haematology investigations (incl blood groups),11,Mild,Grade 1 (Mild),Not Related,None,Resolved,No,No,No,1,IV,T1,PGT121 + VRC07-523LS mo 0,130-11
1,Light-headedness,Nervous system disorders,Dizziness,,Light headedness,Neurological signs and symptoms NEC,Neurological disorders NEC,9,Mild,Grade 1 (Mild),Not Related,None,Resolved,No,No,No,1,IV,T2,PGDM1400 + VRC07-523LS mo 0,130-12
2,Dog Bite,"Injury, poisoning and procedural complications",Animal bite,,Dog bite,Non-site specific injuries NEC,Injuries NEC,11,Moderate,Grade 2 (Moderate),Not Related,Medication,Resolved,No,No,No,1,IV,T2,PGDM1400 + VRC07-523LS mo 0,130-12
1,Infusion-related reaction.,"Injury, poisoning and procedural complications",Infusion related reaction,,Infusion related reaction,Non-site specific procedural complications,Procedural related injuries and complications NEC,2,Mild,Grade 1 (Mild),Related,None,Resolved,No,No,No,1,IV,T2,PGDM1400 + VRC07-523LS mo 0,130-14
1,Urinary tract infection,Infections and infestations,Urinary tract infection,,Urinary tract infection,Urinary tract infections,Infections - pathogen unspecified,12,Moderate,Grade 2 (Moderate),Not Related,Medication,Resolved,No,No,No,1,IV,T4,"PGT121 + PGDM1400 + VRC07-523LS mo (0, 4)",130-15
1,decreased platelets,Investigations,Platelet count decreased,,Platelets decreased,Platelet analyses,Haematology investigations (incl blood groups),7,Mild,Grade 1 (Mild),Not Related,None,Resolved,No,No,No,1,IV,T4,"PGT121 + PGDM1400 + VRC07-523LS mo (0, 4)",130-18
2,decreased platelet count,Investigations,Platelet count decreased,,Platelet count decreased,Platelet analyses,Haematology investigations (incl blood groups),14,Mild,Grade 1 (Mild),Not Related,None,Resolved,No,No,No,1,IV,T4,"PGT121 + PGDM1400 + VRC07-523LS mo (0, 4)",130-18
1,community-acquired URI,Infections and infestations,Upper respiratory tract infection,,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,7,Mild,Grade 1 (Mild),Not Related,None,Resolved,No,No,No,1,IV,T3,10-1074 + VRC07-523LS mo 0,130-20
2,Elevated serum ALT,Investigations,Alanine aminotransferase increased,,ALT increased,Liver function analyses,Hepatobiliary investigations,7,Mild,Grade 1 (Mild),Not Related,None,Resolved,No,No,No,1,IV,T3,10-1074 + VRC07-523LS mo 0,130-20
3,Upper respiratory infection,Infections and infestations,Upper respiratory tract infection,,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,11,Mild,Grade 1 (Mild),Not Related,None,Resolved,No,No,No,1,IV,T3,10-1074 + VRC07-523LS mo 0,130-20
4,eye infection (both eyes),Infections and infestations,Eye infection,,Eye infection,Eye and eyelid infections,Infections - pathogen unspecified,12,Moderate,Grade 2 (Moderate),Not Related,Medication,Resolved,No,No,No,1,IV,T3,10-1074 + VRC07-523LS mo 0,130-20
1,an upper respiratory infection,Infections and infestations,Upper respiratory tract infection,,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,3,Mild,Grade 1 (Mild),Not Related,None,Resolved,No,No,No,1,IV,T1,PGT121 + VRC07-523LS mo 0,130-21
2,Small rash upper Left Triceps area,Skin and subcutaneous tissue disorders,Rash,,Localized rash,"Rashes, eruptions and exanthems NEC",Epidermal and dermal conditions,9,Mild,Grade 1 (Mild),Not Related,None,Resolved,No,No,No,1,IV,T1,PGT121 + VRC07-523LS mo 0,130-21
1,"upper respiratory infection, community-acquired",Infections and infestations,Upper respiratory tract infection,,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,4,Moderate,Grade 2 (Moderate),Not Related,Medication,Resolved,No,No,No,1,IV,T1,PGT121 + VRC07-523LS mo 0,130-22
2,"upper respiratory infection, community-acquired",Infections and infestations,Upper respiratory tract infection,,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,9,Moderate,Grade 2 (Moderate),Not Related,Medication,Resolved,No,No,No,1,IV,T1,PGT121 + VRC07-523LS mo 0,130-22
3,ADD diagnosis,Psychiatric disorders,Attention deficit hyperactivity disorder,,ADD,Attention deficit and disruptive behaviour disorders,Cognitive and attention disorders and disturbances,13,Moderate,Grade 2 (Moderate),Not Related,Medication,Continuing at last scheduled clinic visit,No,No,No,1,IV,T1,PGT121 + VRC07-523LS mo 0,130-22
1,Upper respiratory infection,Infections and infestations,Upper respiratory tract infection,,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,4,Mild,Grade 1 (Mild),Not Related,None,Resolved,No,No,No,1,IV,T2,PGDM1400 + VRC07-523LS mo 0,130-23
2,urinary tract infection,Infections and infestations,Urinary tract infection,,Urinary tract infection,Urinary tract infections,Infections - pathogen unspecified,11,Moderate,Grade 2 (Moderate),Not Related,Medication,Resolved,No,No,No,1,IV,T2,PGDM1400 + VRC07-523LS mo 0,130-23
1,left foot pain,Musculoskeletal and connective tissue disorders,Pain in extremity,,Foot pain,Musculoskeletal and connective tissue pain and discomfort,Musculoskeletal and connective tissue disorders NEC,3,Moderate,Grade 2 (Moderate),Not Related,Referral,Resolved,No,No,No,1,IV,T1,PGT121 + VRC07-523LS mo 0,130-24
2,left buttock pain,Musculoskeletal and connective tissue disorders,Musculoskeletal pain,,Buttock pain,Musculoskeletal and connective tissue pain and discomfort,Musculoskeletal and connective tissue disorders NEC,3,Mild,Grade 1 (Mild),Not Related,None,Resolved,No,No,No,1,IV,T1,PGT121 + VRC07-523LS mo 0,130-24
3,Influenza VIRAL LIKE ILLNESS,General disorders and administration site conditions,Influenza like illness,,Influenza like illness,General signs and symptoms NEC,General system disorders NEC,11,Moderate,Grade 2 (Moderate),Not Related,Medication,Resolved,No,No,No,1,IV,T1,PGT121 + VRC07-523LS mo 0,130-24
1,Subjective Fever,General disorders and administration site conditions,Pyrexia,,Subjective fever,Febrile disorders,Body temperature conditions,12,Mild,Grade 1 (Mild),Not Related,Medication,Resolved,No,No,No,1,IV,T1,PGT121 + VRC07-523LS mo 0,130-25
2,Latent TB DIagnosis,Infections and infestations,Latent tuberculosis,,Latent tuberculosis,Tuberculous infections,Mycobacterial infectious disorders,14,Mild,Grade 1 (Mild),Not Related,None,Continuing at last scheduled clinic visit,No,No,No,1,IV,T1,PGT121 + VRC07-523LS mo 0,130-25
1,Neck Soreness,Musculoskeletal and connective tissue disorders,Neck pain,,Neck pain,Musculoskeletal and connective tissue pain and discomfort,Musculoskeletal and connective tissue disorders NEC,4,Mild,Grade 1 (Mild),Not Related,None,Resolved,No,No,No,1,IV,T4,"PGT121 + PGDM1400 + VRC07-523LS mo (0, 4)",130-26
2,Toothache Lower left Molar,Gastrointestinal disorders,Toothache,,Toothache,Dental pain and sensation disorders,Dental and gingival conditions,6,Moderate,Grade 2 (Moderate),Not Related,"Medication, Referral",Resolved,No,No,No,1,IV,T4,"PGT121 + PGDM1400 + VRC07-523LS mo (0, 4)",130-26
3,Situational Fatigue,General disorders and administration site conditions,Fatigue,,Fatigue,Asthenic conditions,General system disorders NEC,8,Mild,Grade 1 (Mild),Not Related,None,Resolved,No,No,No,1,IV,T4,"PGT121 + PGDM1400 + VRC07-523LS mo (0, 4)",130-26
4,infectious gastroenteritis,Infections and infestations,Gastroenteritis,,Infective gastroenteritis,Abdominal and gastrointestinal infections,Infections - pathogen unspecified,9,Moderate,Grade 2 (Moderate),Not Related,None,Resolved,No,No,No,1,IV,T4,"PGT121 + PGDM1400 + VRC07-523LS mo (0, 4)",130-26
5,viral laryngitis,Infections and infestations,Laryngitis viral,,Viral laryngitis,Viral infections NEC,Viral infectious disorders,9,Moderate,Grade 2 (Moderate),Not Related,Medication,Resolved,No,No,No,1,IV,T4,"PGT121 + PGDM1400 + VRC07-523LS mo (0, 4)",130-26
6,Androgenic Alopecia,Skin and subcutaneous tissue disorders,Androgenetic alopecia,,Androgenic alopecia,Alopecias,Skin appendage conditions,14,Mild,Grade 1 (Mild),Not Related,Medication,Continuing at last scheduled clinic visit,No,No,No,1,IV,T4,"PGT121 + PGDM1400 + VRC07-523LS mo (0, 4)",130-26
7,COVID-19,Infections and infestations,COVID-19,,COVID-19,Coronavirus infections,Viral infectious disorders,16,Mild,Grade 1 (Mild),Not Related,None,Resolved,No,No,No,1,IV,T4,"PGT121 + PGDM1400 + VRC07-523LS mo (0, 4)",130-26
8,Fever,General disorders and administration site conditions,Pyrexia,,Fever,Febrile disorders,Body temperature conditions,16,Mild,Grade 1 (Mild),Not Related,None,Resolved,No,No,No,1,IV,T4,"PGT121 + PGDM1400 + VRC07-523LS mo (0, 4)",130-26
1,increased urinary urgency,Renal and urinary disorders,Micturition urgency,,Urinary urgency,Bladder and urethral symptoms,Urinary tract signs and symptoms,7,Mild,Grade 1 (Mild),Not Related,None,Continuing at last scheduled clinic visit,No,No,No,1,IV,T2,PGDM1400 + VRC07-523LS mo 0,130-27