Study: NCT00321763

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: During the 30-day (Days 0 to 29) post vaccination period.
Frequency: 1 affected / 850 at risk

Adverse event: Cardiac valve disease
Serious: yes
Organ System: Cardiac disorders
Notes: During the 30-day (Days 0 to 29) post vaccination period.
Frequency: 1 affected / 850 at risk

Adverse event: Foot fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: During the 30-day (Days 0 to 29) post vaccination period.
Frequency: 1 affected / 850 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: During the 30-day (Days 0 to 29) post vaccination period.
Frequency: 1 affected / 850 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 2 affected / 844 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 4 affected / 844 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 844 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 2 affected / 844 at risk

Adverse event: Circulatory collapse
Serious: yes
Organ System: Vascular disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 844 at risk

Adverse event: Bile duct stone
Serious: yes
Organ System: Hepatobiliary disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 844 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 844 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Vascular disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 844 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 844 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 844 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 844 at risk

Adverse event: Endometrial cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 844 at risk

Adverse event: Foot deformity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 844 at risk

Adverse event: Foreign body
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 844 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 844 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 844 at risk

Adverse event: Hyperthyroidism
Serious: yes
Organ System: Endocrine disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 844 at risk

Adverse event: Iliac artery stenosis
Serious: yes
Organ System: Vascular disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 844 at risk

Adverse event: Lung disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 844 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 844 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 844 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 844 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 844 at risk

Adverse event: Spinal disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 844 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 844 at risk

Adverse event: Oedema
Serious: yes
Organ System: General disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 844 at risk

Adverse event: Hepatorenal failure
Serious: yes
Organ System: Hepatobiliary disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 844 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 470 affected / 850 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 324 affected / 850 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 241 affected / 850 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 130 affected / 850 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 251 affected / 850 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 45 affected / 850 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 182 affected / 850 at risk

Adverse event: Muscle aches
Serious: no
Organ System: General disorders
Frequency: 254 affected / 850 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 92 affected / 850 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: During the 30-day (Days 0 to 29) post vaccination period.
Frequency: 1 affected / 850 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: General disorders
Notes: During the 30-day (Days 0 to 29) post vaccination period.
Frequency: 1 affected / 850 at risk

Adverse event: Retinal artery embolism
Serious: yes
Organ System: Eye disorders
Notes: During the 30-day (Days 0 to 29) post vaccination period.
Frequency: 1 affected / 850 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Notes: During the 30-day (Days 0 to 29) post vaccination period.
Frequency: 1 affected / 850 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: During the 30-day (Days 0 to 29) post vaccination period.
Frequency: 1 affected / 850 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 2 affected / 848 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 848 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 848 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 2 affected / 848 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 848 at risk

Adverse event: Large intestine polyp
Serious: yes
Organ System: Gastrointestinal disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 848 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 848 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 848 at risk

Adverse event: Cardiovascular disorder
Serious: yes
Organ System: Cardiac disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 848 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 848 at risk

Adverse event: Forearm fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 848 at risk

Adverse event: Gastric cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 848 at risk

Adverse event: Hyperlipidaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 848 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 848 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 848 at risk

Adverse event: Nephrotic syndrome
Serious: yes
Organ System: Renal and urinary disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 848 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 848 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 848 at risk

Adverse event: Stress
Serious: yes
Organ System: Psychiatric disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 848 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 848 at risk

Adverse event: Tachyarrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 848 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 848 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 449 affected / 850 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 297 affected / 850 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 208 affected / 850 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 133 affected / 850 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 210 affected / 850 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 54 affected / 850 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 167 affected / 850 at risk

Adverse event: Muscle aches
Serious: no
Organ System: General disorders
Frequency: 234 affected / 850 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 93 affected / 850 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: During the 30-day (Days 0 to 29) post vaccination period.
Frequency: 1 affected / 854 at risk

Adverse event: Oesophageal stenosis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: During the 30-day (Days 0 to 29) post vaccination period.
Frequency: 1 affected / 854 at risk

Adverse event: Radius fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: During the 30-day (Days 0 to 29) post vaccination period.
Frequency: 1 affected / 854 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 848 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 848 at risk

Adverse event: Circulatory collapse
Serious: yes
Organ System: Vascular disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 848 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 2 affected / 848 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 2 affected / 848 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 848 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 848 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 848 at risk

Adverse event: Cholecystitis infective
Serious: yes
Organ System: Infections and infestations
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 848 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 848 at risk

Adverse event: Skin abrasion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 848 at risk

Adverse event: Mixed connective tissue disease
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 848 at risk

Adverse event: Pulmonary fibrosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 848 at risk

Adverse event: Renal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 848 at risk

Adverse event: Scoliosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 848 at risk

Adverse event: Tachycardia paroxysmal
Serious: yes
Organ System: Cardiac disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 848 at risk

Adverse event: Trigeminal neuralgia
Serious: yes
Organ System: Nervous system disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 848 at risk

Adverse event: Diabetic gangrene
Serious: yes
Organ System: Infections and infestations
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 848 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 848 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 456 affected / 854 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 338 affected / 854 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 238 affected / 854 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 133 affected / 854 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 233 affected / 854 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 44 affected / 854 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 182 affected / 854 at risk

Adverse event: Muscle aches
Serious: no
Organ System: General disorders
Frequency: 245 affected / 854 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 90 affected / 854 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: During the 30-day (Days 0 to 29) post vaccination period.
Frequency: 2 affected / 2554 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: General disorders
Notes: During the 30-day (Days 0 to 29) post vaccination period.
Frequency: 1 affected / 2554 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: During the 30-day (Days 0 to 29) post vaccination period.
Frequency: 1 affected / 2554 at risk

Adverse event: Cardiac valve disease
Serious: yes
Organ System: Cardiac disorders
Notes: During the 30-day (Days 0 to 29) post vaccination period.
Frequency: 1 affected / 2554 at risk

Adverse event: Foot fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: During the 30-day (Days 0 to 29) post vaccination period.
Frequency: 1 affected / 2554 at risk

Adverse event: Oesophageal stenosis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: During the 30-day (Days 0 to 29) post vaccination period.
Frequency: 1 affected / 2554 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: During the 30-day (Days 0 to 29) post vaccination period.
Frequency: 1 affected / 2554 at risk

Adverse event: Radius fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: During the 30-day (Days 0 to 29) post vaccination period.
Frequency: 1 affected / 2554 at risk

Adverse event: Retinal artery embolism
Serious: yes
Organ System: Eye disorders
Notes: During the 30-day (Days 0 to 29) post vaccination period.
Frequency: 1 affected / 2554 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Notes: During the 30-day (Days 0 to 29) post vaccination period.
Frequency: 1 affected / 2554 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: During the 30-day (Days 0 to 29) post vaccination period.
Frequency: 1 affected / 2554 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 5 affected / 2540 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 4 affected / 2540 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 2 affected / 2540 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 2 affected / 2540 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 2 affected / 2540 at risk

Adverse event: Circulatory collapse
Serious: yes
Organ System: Vascular disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 2 affected / 2540 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 2 affected / 2540 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 2 affected / 2540 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 2 affected / 2540 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 2 affected / 2540 at risk

Adverse event: Bile duct stone
Serious: yes
Organ System: Hepatobiliary disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Large intestine polyp
Serious: yes
Organ System: Gastrointestinal disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Vascular disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Cardiovascular disorder
Serious: yes
Organ System: Cardiac disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Cholecystitis infective
Serious: yes
Organ System: Infections and infestations
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Endometrial cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Skin abrasion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Foot deformity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Forearm fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Foreign body
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Gastric cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Hyperlipidaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Hyperthyroidism
Serious: yes
Organ System: Endocrine disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Iliac artery stenosis
Serious: yes
Organ System: Vascular disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Lung disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Mixed connective tissue disease
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Nephrotic syndrome
Serious: yes
Organ System: Renal and urinary disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Pulmonary fibrosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Renal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Scoliosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Spinal disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Stress
Serious: yes
Organ System: Psychiatric disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Tachyarrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Tachycardia paroxysmal
Serious: yes
Organ System: Cardiac disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Trigeminal neuralgia
Serious: yes
Organ System: Nervous system disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Oedema
Serious: yes
Organ System: General disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Hepatorenal failure
Serious: yes
Organ System: Hepatobiliary disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Diabetic gangrene
Serious: yes
Organ System: Infections and infestations
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 2540 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 1375 affected / 2554 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 959 affected / 2554 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 687 affected / 2554 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 396 affected / 2554 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 694 affected / 2554 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 143 affected / 2554 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 531 affected / 2554 at risk

Adverse event: Muscle aches
Serious: no
Organ System: General disorders
Frequency: 733 affected / 2554 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 275 affected / 2554 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Notes: During the 30-day (Days 0 to 29) post vaccination period.
Frequency: 1 affected / 570 at risk

Adverse event: Hand fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: During the 30-day (Days 0 to 29) post vaccination period.
Frequency: 1 affected / 570 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Notes: During the 30-day (Days 0 to 29) post vaccination period.
Frequency: 1 affected / 570 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: During the 30-day (Days 0 to 29) post vaccination period.
Frequency: 1 affected / 570 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 565 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 2 affected / 565 at risk

Adverse event: Bile duct stone
Serious: yes
Organ System: Hepatobiliary disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 565 at risk

Adverse event: Large intestine polyp
Serious: yes
Organ System: Gastrointestinal disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 565 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 565 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 565 at risk

Adverse event: Aortic aneurysm
Serious: yes
Organ System: Vascular disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 565 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 565 at risk

Adverse event: Arteriosclerosis coronary artery
Serious: yes
Organ System: Cardiac disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 565 at risk

Adverse event: Bladder cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 565 at risk

Adverse event: Gallstone ileus
Serious: yes
Organ System: Gastrointestinal disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 565 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 565 at risk

Adverse event: Neoplasm prostate
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 565 at risk

Adverse event: Oesophageal carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 565 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 565 at risk

Adverse event: Small intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 565 at risk

Adverse event: Uterine polyp
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 565 at risk

Adverse event: Rectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 565 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 565 at risk

Adverse event: Thrombotic stroke
Serious: yes
Organ System: Nervous system disorders
Notes: During the post vaccination period between Days 30 and 180.
Frequency: 1 affected / 565 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 170 affected / 570 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 162 affected / 570 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 87 affected / 570 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 47 affected / 570 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 101 affected / 570 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 570 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 77 affected / 570 at risk

Adverse event: Muscle aches
Serious: no
Organ System: General disorders
Frequency: 79 affected / 570 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 28 affected / 570 at risk