Study: NCT00914732

Adverse event: Colitis ischaemic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 165 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 81 affected / 165 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 31 affected / 165 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 83 affected / 165 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 40 affected / 165 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 90 affected / 165 at risk

Adverse event: Appetite disorder
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Solicited as "Change in appetite"
Frequency: 39 affected / 165 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 25 affected / 165 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 155 affected / 165 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 82 affected / 165 at risk

Adverse event: Axillary pain
Serious: no
Organ System: General disorders
Notes: Solicited as "Underarm pain"
Frequency: 25 affected / 165 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: Solicited as "Underarm swelling"
Frequency: 12 affected / 165 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 128 affected / 165 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 108 affected / 165 at risk

Adverse event: Vaccination site discolouration
Serious: no
Organ System: General disorders
Frequency: 16 affected / 165 at risk

Adverse event: Vaccination site haematoma
Serious: no
Organ System: General disorders
Frequency: 9 affected / 165 at risk

Adverse event: Vaccination site nodule
Serious: no
Organ System: General disorders
Frequency: 41 affected / 165 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 165 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 165 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 167 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 167 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 69 affected / 167 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 21 affected / 167 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 72 affected / 167 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 36 affected / 167 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 83 affected / 167 at risk

Adverse event: Appetite disorder
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Solicited as "Change in appetite"
Frequency: 25 affected / 167 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 167 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 152 affected / 167 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 81 affected / 167 at risk

Adverse event: Axillary pain
Serious: no
Organ System: General disorders
Notes: Solicited as "Underarm pain"
Frequency: 30 affected / 167 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: Solicited as "Underarm swelling"
Frequency: 10 affected / 167 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 136 affected / 167 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 116 affected / 167 at risk

Adverse event: Vaccination site discolouration
Serious: no
Organ System: General disorders
Frequency: 7 affected / 167 at risk

Adverse event: Vaccination site haematoma
Serious: no
Organ System: General disorders
Frequency: 6 affected / 167 at risk

Adverse event: Vaccination site nodule
Serious: no
Organ System: General disorders
Frequency: 34 affected / 167 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 167 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 167 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 191 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 58 affected / 191 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 28 affected / 191 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 79 affected / 191 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 44 affected / 191 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 98 affected / 191 at risk

Adverse event: Appetite disorder
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Solicited as "Change in appetite"
Frequency: 39 affected / 191 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 34 affected / 191 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 125 affected / 191 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 170 affected / 191 at risk

Adverse event: Axillary pain
Serious: no
Organ System: General disorders
Notes: Solicited as "Underarm pain"
Frequency: 40 affected / 191 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: Solicited as "Underarm swelling"
Frequency: 20 affected / 191 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 190 affected / 191 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 190 affected / 191 at risk

Adverse event: Vaccination site discolouration
Serious: no
Organ System: General disorders
Frequency: 122 affected / 191 at risk

Adverse event: Vaccination site haematoma
Serious: no
Organ System: General disorders
Frequency: 12 affected / 191 at risk

Adverse event: Vaccination site nodule
Serious: no
Organ System: General disorders
Frequency: 35 affected / 191 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 191 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 191 at risk