Study: NCT00963157

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 156 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 156 at risk

Adverse event: Endometrial cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 156 at risk

Adverse event: Major depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 156 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 156 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 156 at risk

Adverse event: Bladder cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 156 at risk

Adverse event: Post procedural complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 156 at risk

Adverse event: Blood pressure systolic increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 156 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 10 affected / 156 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 156 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 156 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 156 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Frequency: 35 affected / 156 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 66 affected / 156 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 55 affected / 156 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 59 affected / 156 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 156 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 22 affected / 156 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Solicited as "chills"
Frequency: 29 affected / 156 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Solicited as "shivering"
Frequency: 17 affected / 156 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 101 affected / 156 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Notes: Tenderness was solicited as a reaction at the vaccination site.
Frequency: 138 affected / 156 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 54 affected / 156 at risk

Adverse event: Injection site swelling (functional grading)
Serious: no
Organ System: General disorders
Notes: Injection site swelling was solicited separately for functional grading of impact on daily activities and as a measured reaction.
Frequency: 46 affected / 156 at risk

Adverse event: Injection site swelling (measured)
Serious: no
Organ System: General disorders
Notes: Injection site swelling was solicited separately for functional grading of impact on daily activities and as a measured reaction.
Frequency: 48 affected / 156 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 163 at risk

Adverse event: Non-small cell lung cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 163 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 163 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 163 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 163 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 163 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 163 at risk

Adverse event: Hysterectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 163 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 163 at risk

Adverse event: Blood pressure systolic increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 163 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 4 affected / 163 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 163 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 163 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 163 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Frequency: 35 affected / 163 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 67 affected / 163 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 67 affected / 163 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 68 affected / 163 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 163 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 27 affected / 163 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Solicited as "chills"
Frequency: 28 affected / 163 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Solicited as "shivering"
Frequency: 19 affected / 163 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 117 affected / 163 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Notes: Tenderness was solicited as a reaction at the vaccination site.
Frequency: 141 affected / 163 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 52 affected / 163 at risk

Adverse event: Injection site swelling (functional grading)
Serious: no
Organ System: General disorders
Notes: Injection site swelling was solicited separately for functional grading of impact on daily activities and as a measured reaction.
Frequency: 36 affected / 163 at risk

Adverse event: Injection site swelling (measured)
Serious: no
Organ System: General disorders
Notes: Injection site swelling was solicited separately for functional grading of impact on daily activities and as a measured reaction.
Frequency: 40 affected / 163 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 160 at risk

Adverse event: Generalised tonic-clonic seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 160 at risk

Adverse event: Gastric bypass
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 160 at risk

Adverse event: Aqueductal stenosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 160 at risk

Adverse event: Pulmonary tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 160 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 160 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 160 at risk

Adverse event: Pulmonary fibrosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 160 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 160 at risk

Adverse event: Lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 160 at risk

Adverse event: Myelopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 160 at risk

Adverse event: Cystocele
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 160 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 160 at risk

Adverse event: Blood pressure systolic increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 160 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 9 affected / 160 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 160 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 160 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Frequency: 11 affected / 160 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 37 affected / 160 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 22 affected / 160 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 54 affected / 160 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 160 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 160 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Solicited as "chills"
Frequency: 7 affected / 160 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Solicited as "shivering"
Frequency: 6 affected / 160 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 33 affected / 160 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Notes: Tenderness was solicited as a reaction at the vaccination site.
Frequency: 52 affected / 160 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 51 affected / 160 at risk

Adverse event: Injection site swelling (functional grading)
Serious: no
Organ System: General disorders
Notes: Injection site swelling was solicited separately for functional grading of impact on daily activities and as a measured reaction.
Frequency: 33 affected / 160 at risk

Adverse event: Injection site swelling (measured)
Serious: no
Organ System: General disorders
Notes: Injection site swelling was solicited separately for functional grading of impact on daily activities and as a measured reaction.
Frequency: 37 affected / 160 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 157 at risk

Adverse event: Spinal laminectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 157 at risk

Adverse event: Chronic lymphocytic leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 157 at risk

Adverse event: Respiratory fume inhalation disorder
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 157 at risk

Adverse event: Abdominal pain lower
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 157 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 157 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 157 at risk

Adverse event: Pharyngeal oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 157 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 157 at risk

Adverse event: Blood pressure systolic increased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 157 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 5 affected / 157 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 157 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 157 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 157 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Frequency: 44 affected / 157 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 61 affected / 157 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 60 affected / 157 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 47 affected / 157 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 157 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 26 affected / 157 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Solicited as "chills"
Frequency: 30 affected / 157 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Solicited as "shivering"
Frequency: 22 affected / 157 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 102 affected / 157 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Notes: Tenderness was solicited as a reaction at the vaccination site.
Frequency: 128 affected / 157 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 63 affected / 157 at risk

Adverse event: Injection site swelling (functional grading)
Serious: no
Organ System: General disorders
Notes: Injection site swelling was solicited separately for functional grading of impact on daily activities and as a measured reaction.
Frequency: 47 affected / 157 at risk

Adverse event: Injection site swelling (measured)
Serious: no
Organ System: General disorders
Notes: Injection site swelling was solicited separately for functional grading of impact on daily activities and as a measured reaction.
Frequency: 51 affected / 157 at risk

Adverse event: Aortic valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 153 at risk

Adverse event: Atrial septal defect repair
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 153 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 153 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 153 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 153 at risk

Adverse event: Dementia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 153 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 153 at risk

Adverse event: Implantable defibrillator insertion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 153 at risk

Adverse event: Hepatic cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 153 at risk

Adverse event: Haemophilus sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 153 at risk

Adverse event: Blood pressure systolic increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 153 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 8 affected / 153 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 153 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 153 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Frequency: 15 affected / 153 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 44 affected / 153 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 32 affected / 153 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 46 affected / 153 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 153 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 153 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Solicited as "chills"
Frequency: 17 affected / 153 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: Solicited as "shivering"
Frequency: 7 affected / 153 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 47 affected / 153 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Notes: Tenderness was solicited as a reaction at the vaccination site.
Frequency: 70 affected / 153 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 53 affected / 153 at risk

Adverse event: Injection site swelling (functional grading)
Serious: no
Organ System: General disorders
Notes: Injection site swelling was solicited separately for functional grading of impact on daily activities and as a measured reaction.
Frequency: 37 affected / 153 at risk

Adverse event: Injection site swelling (measured)
Serious: no
Organ System: General disorders
Notes: Injection site swelling was solicited separately for functional grading of impact on daily activities and as a measured reaction.
Frequency: 42 affected / 153 at risk