Study: NCT02243371

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 51 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 51 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 51 at risk

Adverse event: Myocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 51 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Vaccination site erythema
Serious: no
Organ System: General disorders
Frequency: 46 affected / 51 at risk

Adverse event: Vaccination site induration
Serious: no
Organ System: General disorders
Frequency: 41 affected / 51 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 42 affected / 51 at risk

Adverse event: Vaccination site pruritus
Serious: no
Organ System: General disorders
Frequency: 36 affected / 51 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 38 affected / 51 at risk

Adverse event: Vaccination site pain
Serious: no
Organ System: General disorders
Frequency: 34 affected / 51 at risk

Adverse event: Vaccination site discomfort
Serious: no
Organ System: General disorders
Frequency: 22 affected / 51 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 23 affected / 51 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 13 affected / 51 at risk

Adverse event: Vaccination site oedema
Serious: no
Organ System: General disorders
Frequency: 9 affected / 51 at risk

Adverse event: Vaccination site swelling
Serious: no
Organ System: General disorders
Frequency: 3 affected / 51 at risk

Adverse event: Vaccination site vesicles
Serious: no
Organ System: General disorders
Frequency: 5 affected / 51 at risk

Adverse event: Vaccination site reaction
Serious: no
Organ System: General disorders
Frequency: 5 affected / 51 at risk

Adverse event: Vaccination site bruising
Serious: no
Organ System: General disorders
Frequency: 4 affected / 51 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 51 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 51 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 51 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 51 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 51 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 51 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 51 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 51 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 51 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 51 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 51 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 51 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 51 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 51 at risk

Adverse event: Listeria sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 42 at risk

Adverse event: Vaccination site erythema
Serious: no
Organ System: General disorders
Frequency: 40 affected / 42 at risk

Adverse event: Vaccination site induration
Serious: no
Organ System: General disorders
Frequency: 31 affected / 42 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 29 affected / 42 at risk

Adverse event: Vaccination site pruritus
Serious: no
Organ System: General disorders
Frequency: 30 affected / 42 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 27 affected / 42 at risk

Adverse event: Vaccination site pain
Serious: no
Organ System: General disorders
Frequency: 29 affected / 42 at risk

Adverse event: Vaccination site discomfort
Serious: no
Organ System: General disorders
Frequency: 21 affected / 42 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 12 affected / 42 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 8 affected / 42 at risk

Adverse event: Vaccination site oedema
Serious: no
Organ System: General disorders
Frequency: 8 affected / 42 at risk

Adverse event: Vaccination site swelling
Serious: no
Organ System: General disorders
Frequency: 5 affected / 42 at risk

Adverse event: Vaccination site vesicles
Serious: no
Organ System: General disorders
Frequency: 3 affected / 42 at risk

Adverse event: Vaccination site reaction
Serious: no
Organ System: General disorders
Frequency: 2 affected / 42 at risk

Adverse event: Vaccination site bruising
Serious: no
Organ System: General disorders
Frequency: 2 affected / 42 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 42 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 42 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 42 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 42 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 42 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 42 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 42 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 42 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 42 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 42 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 42 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 42 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 42 at risk