Study: NCT00492557

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 576 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 576 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 576 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 576 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 576 at risk

Adverse event: Endoscopy small intestine
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 576 at risk

Adverse event: Spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 576 at risk

Adverse event: Redness (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Redness (any) = present at site of vaccination
Frequency: 73 affected / 440 at risk

Adverse event: Redness (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Redness (mild) = 2.5 to 5.0 cm
Frequency: 63 affected / 438 at risk

Adverse event: Redness (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Redness (moderate) = 5.1 to 10.0 cm
Frequency: 26 affected / 433 at risk

Adverse event: Redness (severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Redness (severe) = \>10.0 cm
Frequency: 3 affected / 429 at risk

Adverse event: Swelling (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Swelling (any) = present at site of vaccination
Frequency: 61 affected / 441 at risk

Adverse event: Swelling (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Swelling (mild) = 2.5 to 5.0 cm
Frequency: 52 affected / 440 at risk

Adverse event: Swelling (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Swelling (moderate) = 5.1 to 10.0 cm
Frequency: 18 affected / 432 at risk

Adverse event: Swelling (severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Swelling (severe) = \>10.0 cm
Frequency: 1 affected / 428 at risk

Adverse event: Pain (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pain (any) = present at site of vaccination
Frequency: 192 affected / 480 at risk

Adverse event: Pain (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pain (mild) = awareness of symptoms but easily tolerated
Frequency: 161 affected / 470 at risk

Adverse event: Pain (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pain (moderate) = discomfort enough to cause interference with usual activity
Frequency: 66 affected / 447 at risk

Adverse event: Pain (severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pain (severe) = unable to move above shoulder
Frequency: 6 affected / 429 at risk

Adverse event: Limitation of arm movement (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Limitation of arm movement (any) = present
Frequency: 62 affected / 445 at risk

Adverse event: Limitation of arm movement (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Limitation of arm movement (mild) = some limitation
Frequency: 58 affected / 444 at risk

Adverse event: Limitation of arm movement (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Limitation of arm movement (moderate) = unable to move above head but able to move above shoulder
Frequency: 6 affected / 430 at risk

Adverse event: Limitation of arm movement (severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Limitation of arm movement (severe) = unable to move above shoulder
Frequency: 8 affected / 429 at risk

Adverse event: Fever ≥ 38 degrees C but < 38.5 degrees C
Serious: no
Organ System: General disorders
Frequency: 13 affected / 434 at risk

Adverse event: Fever ≥ 38.5 degrees C but < 39 degrees C
Serious: no
Organ System: General disorders
Frequency: 6 affected / 430 at risk

Adverse event: Fever > 40.0 degrees C
Serious: no
Organ System: General disorders
Frequency: 6 affected / 429 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 178 affected / 476 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 154 affected / 472 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 61 affected / 443 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Frequency: 30 affected / 433 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 13 affected / 432 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 76 affected / 450 at risk

Adverse event: New muscle pain
Serious: no
Organ System: General disorders
Frequency: 126 affected / 468 at risk

Adverse event: Any aggravated muscle pain
Serious: no
Organ System: General disorders
Frequency: 85 affected / 454 at risk

Adverse event: New joint pain
Serious: no
Organ System: General disorders
Frequency: 73 affected / 452 at risk

Adverse event: Any aggravated joint pain
Serious: no
Organ System: General disorders
Frequency: 71 affected / 452 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 576 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 576 at risk

Adverse event: Glaucoma
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 576 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 576 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 576 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 576 at risk

Adverse event: Colitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 576 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 576 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 2 affected / 576 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 576 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 576 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 576 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 576 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 576 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 576 at risk

Adverse event: Localised infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 576 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 576 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 576 at risk

Adverse event: Enterovirus infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 576 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 576 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 576 at risk

Adverse event: Tracheobronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 576 at risk

Adverse event: Traumatic haematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 576 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 576 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 576 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 576 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 576 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 576 at risk

Adverse event: Osteitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 576 at risk

Adverse event: Spinal osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 576 at risk

Adverse event: Tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 576 at risk

Adverse event: Cervicobrachial syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 576 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 576 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 576 at risk

Adverse event: Restless legs syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 576 at risk

Adverse event: Post-traumatic stress disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 576 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 576 at risk

Adverse event: Bartholin's cyst
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 576 at risk

Adverse event: Fibrocystic breast disease
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 576 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 576 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 576 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 576 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 576 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 576 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 576 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 576 at risk

Adverse event: Dermatitis bullous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 576 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 576 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 559 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 559 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 559 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 559 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 559 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 559 at risk

Adverse event: Electrocardiogram ST segment elevation
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 559 at risk

Adverse event: Bladder neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 559 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 559 at risk

Adverse event: Cardiac pacemaker insertion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 559 at risk

Adverse event: Redness (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Redness (any) = present at site of vaccination
Frequency: 6 affected / 393 at risk

Adverse event: Redness (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Redness (mild) = 2.5 to 5.0 cm
Frequency: 6 affected / 393 at risk

Adverse event: Swelling (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Swelling (any) = present at site of vaccination
Frequency: 4 affected / 394 at risk

Adverse event: Swelling (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Swelling (mild) = 2.5 to 5.0 cm
Frequency: 4 affected / 394 at risk

Adverse event: Swelling (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Swelling (moderate) = 5.1 to 10.0 cm
Frequency: 1 affected / 393 at risk

Adverse event: Pain (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pain (any) = present at site of vaccination
Frequency: 40 affected / 411 at risk

Adverse event: Pain (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pain (mild) = awareness of symptoms but easily tolerated
Frequency: 33 affected / 408 at risk

Adverse event: Pain (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pain (moderate) = discomfort enough to cause interference with usual activity
Frequency: 10 affected / 397 at risk

Adverse event: Limitation of arm movement (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Limitation of arm movement (any) = present
Frequency: 20 affected / 397 at risk

Adverse event: Limitation of arm movement (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Limitation of arm movement (mild) = some limitation
Frequency: 17 affected / 397 at risk

Adverse event: Limitation of arm movement (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Limitation of arm movement (moderate) = unable to move above head but able to move above shoulder
Frequency: 4 affected / 393 at risk

Adverse event: Limitation of arm movement (severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Limitation of arm movement (severe) = unable to move above shoulder
Frequency: 4 affected / 392 at risk

Adverse event: Fever ≥ 38 degrees C but < 38.5 degrees C
Serious: no
Organ System: General disorders
Frequency: 8 affected / 398 at risk

Adverse event: Fever ≥ 38.5 degrees C but < 39 degrees C
Serious: no
Organ System: General disorders
Frequency: 4 affected / 394 at risk

Adverse event: Fever ≥ 39 degrees C but ≤ 40.0 degrees C
Serious: no
Organ System: General disorders
Frequency: 3 affected / 394 at risk

Adverse event: Fever > 40.0 degrees C
Serious: no
Organ System: General disorders
Frequency: 4 affected / 393 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 120 affected / 434 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 114 affected / 436 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 32 affected / 404 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Frequency: 10 affected / 397 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 12 affected / 398 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 58 affected / 415 at risk

Adverse event: New muscle pain
Serious: no
Organ System: General disorders
Frequency: 47 affected / 413 at risk

Adverse event: Any aggravated muscle pain
Serious: no
Organ System: General disorders
Frequency: 44 affected / 410 at risk

Adverse event: New joint pain
Serious: no
Organ System: General disorders
Frequency: 45 affected / 408 at risk

Adverse event: Any aggravated joint pain
Serious: no
Organ System: General disorders
Frequency: 45 affected / 407 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 559 at risk

Adverse event: Cardiac disorder
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 559 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 559 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 559 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 559 at risk

Adverse event: Glaucoma
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 559 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 559 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 559 at risk

Adverse event: Cheilitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 559 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 559 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 559 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 559 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 559 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 559 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 559 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 559 at risk

Adverse event: Localised infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 559 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 559 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 559 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 559 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 559 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 559 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 559 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 559 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 559 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 559 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 559 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 559 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 559 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 559 at risk

Adverse event: Tonsillitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 559 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 559 at risk

Adverse event: Concussion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 559 at risk

Adverse event: Fibula fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 559 at risk

Adverse event: Joint dislocation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 559 at risk

Adverse event: Post procedural haematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 559 at risk

Adverse event: Ulna fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 559 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 559 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 559 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 559 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 559 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 559 at risk

Adverse event: Bursitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 559 at risk

Adverse event: Osteitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 559 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 559 at risk

Adverse event: Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 559 at risk

Adverse event: Myositis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 559 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 559 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 559 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 559 at risk

Adverse event: Vertebrobasilar insufficiency
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 559 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 559 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 559 at risk

Adverse event: Urge incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 559 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 559 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 559 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 559 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 559 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 559 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 559 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 559 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 559 at risk

Adverse event: Redness (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Redness (any) = present at site of vaccination
Frequency: 11 affected / 433 at risk

Adverse event: Redness (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Redness (mild) = 2.5 to 5.0 cm
Frequency: 6 affected / 433 at risk

Adverse event: Redness (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Redness (moderate) = 5.1 to 10.0 cm
Frequency: 5 affected / 431 at risk

Adverse event: Swelling (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Swelling (any) = present at site of vaccination
Frequency: 12 affected / 435 at risk

Adverse event: Swelling (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Swelling (mild) = 2.5 to 5.0 cm
Frequency: 9 affected / 434 at risk

Adverse event: Swelling (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Swelling (moderate) = 5.1 to 10.0 cm
Frequency: 5 affected / 433 at risk

Adverse event: Swelling (severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Swelling (severe) = \>10.0 cm
Frequency: 1 affected / 431 at risk

Adverse event: Pain (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pain (any) = present at site of vaccination
Frequency: 45 affected / 445 at risk

Adverse event: Pain (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pain (mild) = awareness of symptoms but easily tolerated
Frequency: 40 affected / 443 at risk

Adverse event: Pain (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pain (moderate) = discomfort enough to cause interference with usual activity
Frequency: 14 affected / 437 at risk

Adverse event: Limitation of arm movement (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Limitation of arm movement (any) = present
Frequency: 26 affected / 440 at risk

Adverse event: Limitation of arm movement (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Limitation of arm movement (mild) = some limitation
Frequency: 26 affected / 440 at risk

Adverse event: Limitation of arm movement (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Limitation of arm movement (moderate) = unable to move above head but able to move above shoulder
Frequency: 1 affected / 432 at risk

Adverse event: Fever ≥ 38 degrees C but < 38.5 degrees C
Serious: no
Organ System: General disorders
Frequency: 8 affected / 434 at risk

Adverse event: Fever ≥ 38.5 degrees C but < 39 degrees C
Serious: no
Organ System: General disorders
Frequency: 5 affected / 433 at risk

Adverse event: Fever ≥ 39 degrees C but ≤ 40.0 degrees C
Serious: no
Organ System: General disorders
Frequency: 1 affected / 431 at risk

Adverse event: Fever > 40.0 degrees C
Serious: no
Organ System: General disorders
Frequency: 10 affected / 438 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 154 affected / 483 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 139 affected / 468 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 40 affected / 440 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Frequency: 15 affected / 436 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 15 affected / 437 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 66 affected / 452 at risk

Adverse event: New muscle pain
Serious: no
Organ System: General disorders
Frequency: 76 affected / 456 at risk

Adverse event: Any aggravated muscle pain
Serious: no
Organ System: General disorders
Frequency: 63 affected / 449 at risk

Adverse event: New joint pain
Serious: no
Organ System: General disorders
Frequency: 59 affected / 451 at risk

Adverse event: Any aggravated joint pain
Serious: no
Organ System: General disorders
Frequency: 58 affected / 447 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 575 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 575 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 575 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 575 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 575 at risk

Adverse event: Oral pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 575 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 575 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 575 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 575 at risk

Adverse event: Sensation of foreign body
Serious: no
Organ System: General disorders
Frequency: 1 affected / 575 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 575 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 575 at risk

Adverse event: Localised infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 575 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 575 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 575 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 575 at risk

Adverse event: Eyelid infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 575 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 575 at risk

Adverse event: Oesophageal candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 575 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 575 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 575 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 575 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 575 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 575 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 575 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 575 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 575 at risk

Adverse event: Tendon rupture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 575 at risk

Adverse event: Wrist fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 575 at risk

Adverse event: Total lung capacity decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 575 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 575 at risk

Adverse event: Gout
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 575 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 575 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 575 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 575 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 575 at risk

Adverse event: Bursitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 575 at risk

Adverse event: Groin pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 575 at risk

Adverse event: Joint swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 575 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 575 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 575 at risk

Adverse event: Tenosynovitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 575 at risk

Adverse event: Balance disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 575 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 575 at risk

Adverse event: Transient ischaemic attack
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 575 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 575 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 575 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 575 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 575 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 575 at risk

Adverse event: Diaphragmatic hernia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 575 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 575 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 575 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 575 at risk

Adverse event: Drug eruption
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 575 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 575 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 575 at risk

Adverse event: Phlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 575 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 558 at risk

Adverse event: Duodenal ulcer perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 558 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 558 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 558 at risk

Adverse event: Sternal fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 558 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 558 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 558 at risk

Adverse event: Redness (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Redness (any) = present at site of vaccination
Frequency: 53 affected / 432 at risk

Adverse event: Redness (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Redness (mild) = 2.5 to 5.0 cm
Frequency: 42 affected / 432 at risk

Adverse event: Redness (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Redness (moderate) = 5.1 to 10.0 cm
Frequency: 26 affected / 424 at risk

Adverse event: Redness (severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Redness (severe) = \>10.0 cm
Frequency: 4 affected / 420 at risk

Adverse event: Swelling (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Swelling (any) = present at site of vaccination
Frequency: 44 affected / 431 at risk

Adverse event: Swelling (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Swelling (mild) = 2.5 to 5.0 cm
Frequency: 35 affected / 430 at risk

Adverse event: Swelling (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Swelling (moderate) = 5.1 to 10.0 cm
Frequency: 21 affected / 423 at risk

Adverse event: Pain (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pain (any) = present at site of vaccination
Frequency: 204 affected / 470 at risk

Adverse event: Pain (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pain (mild) = awareness of symptoms but easily tolerated
Frequency: 175 affected / 462 at risk

Adverse event: Pain (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pain (moderate) = discomfort enough to cause interference with usual activity
Frequency: 87 affected / 442 at risk

Adverse event: Pain (severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pain (severe) = unable to move above shoulder
Frequency: 11 affected / 421 at risk

Adverse event: Limitation of arm movement (any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Limitation of arm movement (any) = present
Frequency: 64 affected / 432 at risk

Adverse event: Limitation of arm movement (mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Limitation of arm movement (mild) = some limitation
Frequency: 58 affected / 432 at risk

Adverse event: Limitation of arm movement (moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Limitation of arm movement (moderate) = unable to move above head but able to move above shoulder
Frequency: 4 affected / 420 at risk

Adverse event: Limitation of arm movement (severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Limitation of arm movement (severe) = unable to move above shoulder
Frequency: 6 affected / 420 at risk

Adverse event: Fever ≥ 38 degrees C but < 38.5 degrees C
Serious: no
Organ System: General disorders
Frequency: 13 affected / 423 at risk

Adverse event: Fever ≥ 38.5 degrees C but < 39 degrees C
Serious: no
Organ System: General disorders
Frequency: 4 affected / 421 at risk

Adverse event: Fever > 40.0 degrees C
Serious: no
Organ System: General disorders
Frequency: 3 affected / 422 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 130 affected / 456 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 111 affected / 449 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 39 affected / 429 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Frequency: 29 affected / 427 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 7 affected / 424 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 49 affected / 434 at risk

Adverse event: New muscle pain
Serious: no
Organ System: General disorders
Frequency: 105 affected / 448 at risk

Adverse event: Any aggravated muscle pain
Serious: no
Organ System: General disorders
Frequency: 66 affected / 439 at risk

Adverse event: New joint pain
Serious: no
Organ System: General disorders
Frequency: 50 affected / 435 at risk

Adverse event: Any aggravated joint pain
Serious: no
Organ System: General disorders
Frequency: 37 affected / 428 at risk

Adverse event: Myocardial ischaemia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 558 at risk

Adverse event: Deafness unilateral
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 558 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 558 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 558 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 558 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 558 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 558 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 558 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 558 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 558 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 558 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 558 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 558 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 558 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 558 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 558 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 558 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 558 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 558 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 558 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 558 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 558 at risk

Adverse event: Erysipelas
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 558 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 558 at risk

Adverse event: Fungal skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 558 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 558 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 558 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 558 at risk

Adverse event: Traumatic haematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 558 at risk

Adverse event: Wrist fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 558 at risk

Adverse event: Corneal abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 558 at risk

Adverse event: Radius fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 558 at risk

Adverse event: Rib fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 558 at risk

Adverse event: Cardiac murmur
Serious: no
Organ System: Investigations
Frequency: 1 affected / 558 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 558 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 558 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 558 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 558 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 558 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 558 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 558 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 558 at risk

Adverse event: Nephrocalcinosis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 558 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 558 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 558 at risk

Adverse event: Dyspnoea exertional
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 558 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 558 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 558 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 558 at risk

Adverse event: Dental prosthesis user
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 558 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 558 at risk