Study: NCT00943878

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 202 at risk

Adverse event: Gammopathy
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 202 at risk

Adverse event: Lower limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 202 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 202 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 202 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 202 at risk

Adverse event: Carotid artery stenosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 202 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 18 affected / 202 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 202 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 202 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 202 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Frequency: 26 affected / 202 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 59 affected / 202 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 42 affected / 202 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 64 affected / 202 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 202 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 66 affected / 202 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Notes: Tenderness was solicited as a reaction at the vaccination site.
Frequency: 98 affected / 202 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 73 affected / 202 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: 57 affected / 202 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: 61 affected / 202 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 200 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 200 at risk

Adverse event: Cervicobrachial syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 200 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 200 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 200 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 200 at risk

Adverse event: Tongue neoplasm malignant stage unspecified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 200 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 30 affected / 200 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 200 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 200 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 200 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Frequency: 24 affected / 200 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 61 affected / 200 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 40 affected / 200 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 62 affected / 200 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 200 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 87 affected / 200 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Notes: Tenderness was solicited as a reaction at the vaccination site.
Frequency: 115 affected / 200 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 67 affected / 200 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: 56 affected / 200 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: 59 affected / 200 at risk

Adverse event: Brain neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 203 at risk

Adverse event: Heavy menstrual bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 203 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 203 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 203 at risk

Adverse event: Tonsil cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 203 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 203 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 203 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 203 at risk

Adverse event: Coronary artery stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 203 at risk

Adverse event: Intestinal ischaemia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 203 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 203 at risk

Adverse event: Renal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 203 at risk

Adverse event: Carotid sinus syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 203 at risk

Adverse event: Oesophageal disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 203 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 20 affected / 203 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 203 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 203 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 203 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Frequency: 20 affected / 203 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 57 affected / 203 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 39 affected / 203 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 60 affected / 203 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 203 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 72 affected / 203 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Notes: Tenderness was solicited as a reaction at the vaccination site.
Frequency: 111 affected / 203 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 71 affected / 203 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: 50 affected / 203 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: 52 affected / 203 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 200 at risk

Adverse event: Knee arthroplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 200 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 200 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 200 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 200 at risk

Adverse event: Hypervitaminosis A
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 200 at risk

Adverse event: Myelopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 200 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 200 at risk

Adverse event: Radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 200 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 200 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 200 at risk

Adverse event: Metastasis
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 200 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 200 at risk

Adverse event: Hyperparathyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 200 at risk

Adverse event: Hypoaesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 200 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 200 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 18 affected / 200 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 200 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 200 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 200 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Frequency: 24 affected / 200 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 55 affected / 200 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 37 affected / 200 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 60 affected / 200 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 200 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 67 affected / 200 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Notes: Tenderness was solicited as a reaction at the vaccination site.
Frequency: 109 affected / 200 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 75 affected / 200 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: 59 affected / 200 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: 61 affected / 200 at risk