Study: NCT02067676

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 8 at risk

Adverse event: Vaccine site erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Related
Frequency: 3 affected / 8 at risk

Adverse event: Vaccine site induration
Serious: no
Organ System: General disorders
Notes: Related
Frequency: 2 affected / 8 at risk

Adverse event: Vaccine site pain
Serious: no
Organ System: General disorders
Notes: Related
Frequency: 2 affected / 8 at risk

Adverse event: Vaccine site tenderness
Serious: no
Organ System: General disorders
Notes: Related
Frequency: 3 affected / 8 at risk

Adverse event: Pericarditis
Serious: no
Organ System: Cardiac disorders
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Elevated ALT
Serious: no
Organ System: Investigations
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Elevated AST
Serious: no
Organ System: Investigations
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Elevated cosinophils
Serious: no
Organ System: Investigations
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Unrelated
Frequency: 4 affected / 8 at risk

Adverse event: Left eyelid twitching
Serious: no
Organ System: Nervous system disorders
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Loose stool
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Related
Frequency: 1 affected / 8 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Related
Frequency: 1 affected / 8 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Related
Frequency: 2 affected / 8 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Related
Frequency: 2 affected / 8 at risk

Adverse event: Sweats
Serious: no
Organ System: General disorders
Notes: Related
Frequency: 1 affected / 8 at risk

Adverse event: Vaccine site induration
Serious: no
Organ System: General disorders
Notes: Related
Frequency: 1 affected / 8 at risk

Adverse event: Vaccine site pain
Serious: no
Organ System: General disorders
Notes: Related
Frequency: 3 affected / 8 at risk

Adverse event: Vaccine site tenderness
Serious: no
Organ System: General disorders
Notes: Related
Frequency: 6 affected / 8 at risk

Adverse event: Allergy headache
Serious: no
Organ System: Nervous system disorders
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Ecchymosis LUE
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Elevated AST
Serious: no
Organ System: Investigations
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Elevated blood glucose
Serious: no
Organ System: Investigations
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Elevated cosinophils
Serious: no
Organ System: Investigations
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Elevated WBC
Serious: no
Organ System: Investigations
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Feverish chills
Serious: no
Organ System: General disorders
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Loose stool
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated
Frequency: 2 affected / 8 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated
Frequency: 2 affected / 8 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Sunburn
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated
Frequency: 2 affected / 8 at risk

Adverse event: Upper respiratory infection symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Related
Frequency: 1 affected / 8 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Related
Frequency: 1 affected / 8 at risk

Adverse event: Phantom sensation LUE
Serious: no
Organ System: General disorders
Notes: Related
Frequency: 1 affected / 8 at risk

Adverse event: Vaccine site erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Related
Frequency: 2 affected / 8 at risk

Adverse event: Vaccine site induration
Serious: no
Organ System: General disorders
Notes: Related
Frequency: 2 affected / 8 at risk

Adverse event: Vaccine site pain
Serious: no
Organ System: General disorders
Notes: Related
Frequency: 1 affected / 8 at risk

Adverse event: Vaccine site tenderness
Serious: no
Organ System: General disorders
Notes: Related
Frequency: 2 affected / 8 at risk

Adverse event: Abdominal pain/cramping
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Elevated blood glucose
Serious: no
Organ System: Investigations
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Sweats
Serious: no
Organ System: General disorders
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Related
Frequency: 1 affected / 8 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Related
Frequency: 1 affected / 8 at risk

Adverse event: LUE pain
Serious: no
Organ System: General disorders
Notes: Related
Frequency: 1 affected / 8 at risk

Adverse event: LUE tenderness
Serious: no
Organ System: General disorders
Notes: Related
Frequency: 1 affected / 8 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Related
Frequency: 1 affected / 8 at risk

Adverse event: Vaccine site erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Related
Frequency: 5 affected / 8 at risk

Adverse event: Vaccine site induration
Serious: no
Organ System: General disorders
Notes: Related
Frequency: 3 affected / 8 at risk

Adverse event: Vaccine site nodule
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Related
Frequency: 1 affected / 8 at risk

Adverse event: Vaccine site pain
Serious: no
Organ System: General disorders
Notes: Related
Frequency: 6 affected / 8 at risk

Adverse event: Vaccine site swelling
Serious: no
Organ System: General disorders
Notes: Related
Frequency: 1 affected / 8 at risk

Adverse event: Vaccine site tenderness
Serious: no
Organ System: General disorders
Notes: Related
Frequency: 8 affected / 8 at risk

Adverse event: Hemoglobin decrease
Serious: no
Organ System: Investigations
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Adbominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Related
Frequency: 1 affected / 8 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Related
Frequency: 1 affected / 8 at risk

Adverse event: Loose stool
Serious: no
Organ System: Gastrointestinal disorders
Notes: Related
Frequency: 1 affected / 8 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Related
Frequency: 1 affected / 8 at risk

Adverse event: Vaccine site erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Related
Frequency: 4 affected / 8 at risk

Adverse event: Vaccine site induration
Serious: no
Organ System: General disorders
Notes: Related
Frequency: 3 affected / 8 at risk

Adverse event: Vaccine site pain
Serious: no
Organ System: General disorders
Notes: Related
Frequency: 1 affected / 8 at risk

Adverse event: Vaccine site swelling
Serious: no
Organ System: General disorders
Notes: Related
Frequency: 1 affected / 8 at risk

Adverse event: Vaccine site tenderness
Serious: no
Organ System: General disorders
Notes: Related
Frequency: 7 affected / 8 at risk

Adverse event: Ankel sprain-right
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Decreased blood glucose
Serious: no
Organ System: Investigations
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Decreased platelets
Serious: no
Organ System: Investigations
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Hangover symptoms
Serious: no
Organ System: General disorders
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Hemoglobin decrease
Serious: no
Organ System: Investigations
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Increased cosinophil
Serious: no
Organ System: Investigations
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Loose stool
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 2 affected / 8 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated
Frequency: 2 affected / 8 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Right fingertip pareshesias
Serious: no
Organ System: Nervous system disorders
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Soft tissue chest muscle pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Sweats
Serious: no
Organ System: General disorders
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Related
Frequency: 1 affected / 8 at risk

Adverse event: Vaccine site ecchymosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Related
Frequency: 1 affected / 8 at risk

Adverse event: Vaccine site erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Related
Frequency: 2 affected / 8 at risk

Adverse event: Vaccine site induration
Serious: no
Organ System: General disorders
Notes: Related
Frequency: 2 affected / 8 at risk

Adverse event: Vaccine site pain
Serious: no
Organ System: General disorders
Notes: Related
Frequency: 1 affected / 8 at risk

Adverse event: Vaccine site swelling
Serious: no
Organ System: General disorders
Notes: Related
Frequency: 1 affected / 8 at risk

Adverse event: Vaccine site tenderness
Serious: no
Organ System: General disorders
Notes: Related
Frequency: 8 affected / 8 at risk

Adverse event: Abdominal pain/cramping
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Immune system disorders
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Hemoglobin decrease
Serious: no
Organ System: Investigations
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Loose stool
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 8 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 2 affected / 8 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated
Frequency: 1 affected / 8 at risk