Study: NCT00546572

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 463 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 463 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 463 at risk

Adverse event: Ischaemic cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 463 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 463 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 463 at risk

Adverse event: Hypoacusis
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 463 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 463 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 463 at risk

Adverse event: Abdominal pain lower
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 463 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 463 at risk

Adverse event: Large intestine polyp
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 463 at risk

Adverse event: Diverticulum
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 463 at risk

Adverse event: Duodenal ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 463 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 463 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 463 at risk

Adverse event: Melaena
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 463 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 463 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 463 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 463 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 463 at risk

Adverse event: Vaccination site haematoma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 463 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 463 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 463 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 463 at risk

Adverse event: Labyrinthitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 463 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 463 at risk

Adverse event: Borrelia infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 463 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 463 at risk

Adverse event: Vulvovaginal candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 463 at risk

Adverse event: Wound infecton
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 463 at risk

Adverse event: Animal bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 463 at risk

Adverse event: Hand fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 463 at risk

Adverse event: Foreign body in eye
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 463 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 463 at risk

Adverse event: Ligament rupture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 463 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 463 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 463 at risk

Adverse event: Gout
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 463 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 463 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 463 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 463 at risk

Adverse event: Bursitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 463 at risk

Adverse event: Joint swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 463 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 463 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 463 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 463 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 463 at risk

Adverse event: Pelvic deformity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 463 at risk

Adverse event: Lipoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 463 at risk

Adverse event: Seborrhoeic keratosis
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 463 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 463 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 463 at risk

Adverse event: Balance disorder
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 463 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 463 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 463 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 463 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 463 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 463 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 463 at risk

Adverse event: Rash erythematous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 463 at risk

Adverse event: Haemangioma of skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 463 at risk

Adverse event: Cutis laxa
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 463 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 463 at risk

Adverse event: Eczema nummular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 463 at risk

Adverse event: Ingrowing nail
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 463 at risk

Adverse event: Swelling face
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 463 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 463 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 463 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 33 affected / 306 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 29 affected / 304 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 14 affected / 301 at risk

Adverse event: Redness (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 5 affected / 299 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 32 affected / 307 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 27 affected / 305 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 12 affected / 299 at risk

Adverse event: Pain (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 187 affected / 362 at risk

Adverse event: Pain (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 180 affected / 359 at risk

Adverse event: Pain (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 23 affected / 306 at risk

Adverse event: Pain (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 4 affected / 299 at risk

Adverse event: Limitation of arm movement (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 33 affected / 313 at risk

Adverse event: Limitation of arm movement (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 32 affected / 312 at risk

Adverse event: Limitation of arm movement (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 1 affected / 297 at risk

Adverse event: Limitation of arm movement (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 2 affected / 298 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 18 affected / 185 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 15 affected / 182 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 8 affected / 182 at risk

Adverse event: Redness (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 2 affected / 179 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 17 affected / 185 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 12 affected / 182 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 6 affected / 179 at risk

Adverse event: Pain (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 142 affected / 258 at risk

Adverse event: Pain (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 133 affected / 251 at risk

Adverse event: Pain (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 16 affected / 187 at risk

Adverse event: Pain (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 3 affected / 179 at risk

Adverse event: Limitation of arm movement (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 19 affected / 195 at risk

Adverse event: Limitation of arm movement (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 18 affected / 194 at risk

Adverse event: Limitation of arm movement (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 1 affected / 178 at risk

Adverse event: Limitation of arm movement (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 1 affected / 178 at risk

Adverse event: Fever (Any) ≥ 38 degrees Celsius (C)
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 3 affected / 299 at risk

Adverse event: Fever (Mild) ≥ 38 degrees but < 38.5 degrees C
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 3 affected / 299 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 119 affected / 350 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 78 affected / 329 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 24 affected / 305 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 22 affected / 303 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 5 affected / 300 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 33 affected / 317 at risk

Adverse event: New generalized muscle pain
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 127 affected / 345 at risk

Adverse event: Aggravated generalized muscle pain
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 66 affected / 320 at risk

Adverse event: New generalized joint pain
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 39 affected / 310 at risk

Adverse event: Aggravated generalized joint pain
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 36 affected / 310 at risk

Adverse event: Fever (Any) ≥ 38 degrees C
Serious: no
Organ System: General disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 3 affected / 179 at risk

Adverse event: Fever (Mild) ≥ 38 degrees but < 38.5 degrees C
Serious: no
Organ System: General disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 3 affected / 179 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 72 affected / 215 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 46 affected / 200 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 17 affected / 182 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 15 affected / 183 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 2 affected / 178 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 16 affected / 190 at risk

Adverse event: New generalized muscle pain
Serious: no
Organ System: General disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 83 affected / 219 at risk

Adverse event: Aggravated generalized muscle pain
Serious: no
Organ System: General disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 41 affected / 198 at risk

Adverse event: New generalized joint pain
Serious: no
Organ System: General disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 21 affected / 187 at risk

Adverse event: Aggravated generalized joint pain
Serious: no
Organ System: General disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 21 affected / 188 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 473 at risk

Adverse event: Diverticulum intestinal haemorrhagic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 473 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 473 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 473 at risk

Adverse event: Bladder cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 473 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 473 at risk

Adverse event: Renal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 473 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 473 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 473 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 473 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 473 at risk

Adverse event: Cerumen impaction
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 473 at risk

Adverse event: Vertigo positional
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 473 at risk

Adverse event: Hyperthyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 473 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 473 at risk

Adverse event: Eye discharge
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 473 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 473 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 473 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 473 at risk

Adverse event: Haemorrhoidal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 473 at risk

Adverse event: Lip pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 473 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 3 affected / 473 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 473 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 2 affected / 473 at risk

Adverse event: Injection site movement impairment
Serious: no
Organ System: General disorders
Frequency: 2 affected / 473 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 473 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 473 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 473 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 473 at risk

Adverse event: Injection site mass
Serious: no
Organ System: General disorders
Frequency: 1 affected / 473 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 473 at risk

Adverse event: Vaccination site haematoma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 473 at risk

Adverse event: Vaccination site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 473 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 473 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 473 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 473 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 473 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 473 at risk

Adverse event: Eye infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 473 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 473 at risk

Adverse event: Labyrinthitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 473 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 473 at risk

Adverse event: Diverticulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 473 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 473 at risk

Adverse event: Tinea cruris
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 473 at risk

Adverse event: Animal bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 473 at risk

Adverse event: Hand fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 473 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 473 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 473 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 473 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 473 at risk

Adverse event: Tendon rupture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 473 at risk

Adverse event: Tibia fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 473 at risk

Adverse event: Biopsy skin
Serious: no
Organ System: Investigations
Frequency: 1 affected / 473 at risk

Adverse event: Blood parathyroid hormone increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 473 at risk

Adverse event: Gout
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 473 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 473 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 473 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 473 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 473 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 473 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 473 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 473 at risk

Adverse event: Joint range of motion decreased
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 473 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 473 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 473 at risk

Adverse event: Rotator cuff syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 473 at risk

Adverse event: Spinal stenosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 473 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 473 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 473 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 473 at risk

Adverse event: Sinus headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 473 at risk

Adverse event: Benign prostatic hyperplasia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 473 at risk

Adverse event: Prostatitis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 473 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 473 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 473 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 473 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 473 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 473 at risk

Adverse event: Actinic keratosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 473 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 473 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 473 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 473 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 72 affected / 324 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 42 affected / 311 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 36 affected / 314 at risk

Adverse event: Redness (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 15 affected / 310 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 77 affected / 333 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 44 affected / 315 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 44 affected / 323 at risk

Adverse event: Swelling (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 15 affected / 310 at risk

Adverse event: Pain (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 224 affected / 383 at risk

Adverse event: Pain (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 204 affected / 377 at risk

Adverse event: Pain (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 78 affected / 330 at risk

Adverse event: Pain (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 7 affected / 306 at risk

Adverse event: Limitation of arm movement (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 90 affected / 326 at risk

Adverse event: Limitation of arm movement (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 81 affected / 322 at risk

Adverse event: Limitation of arm movement (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 8 affected / 303 at risk

Adverse event: Limitation of arm movement (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 9 affected / 305 at risk

Adverse event: Fever (Any) ≥ 38 degrees Celsius (C)
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 13 affected / 309 at risk

Adverse event: Fever (Mild) ≥ 38 degrees but < 38.5 degrees C
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 6 affected / 303 at risk

Adverse event: Fever (Severe) ≥ 39 degrees but ≤ 40 degrees C
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 1 affected / 301 at risk

Adverse event: Fever (Potentially life threatening) > 40 degrees C
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 6 affected / 307 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 159 affected / 367 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 86 affected / 331 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 35 affected / 312 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 53 affected / 323 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 4 affected / 304 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 36 affected / 313 at risk

Adverse event: New generalized muscle pain
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 160 affected / 358 at risk

Adverse event: Aggravated generalized muscle pain
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 92 affected / 334 at risk

Adverse event: New generalized joint pain
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 48 affected / 323 at risk

Adverse event: Aggravated generalized joint pain
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 53 affected / 322 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 463 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 463 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 463 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 463 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 463 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 463 at risk

Adverse event: Diastolic dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 463 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 463 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 463 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 463 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 463 at risk

Adverse event: Streptococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 463 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 463 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 463 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 463 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 463 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 463 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 463 at risk

Adverse event: Musculoskeletal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 463 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 463 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 463 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 463 at risk

Adverse event: Parkinson's disease
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 463 at risk

Adverse event: Neurogenic bladder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 463 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 463 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 463 at risk

Adverse event: Obstructive airways disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 463 at risk

Adverse event: Aortic aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 463 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 463 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 463 at risk

Adverse event: Coronary artery disease
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 463 at risk

Adverse event: Mitral valve incompetence
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 463 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 463 at risk

Adverse event: Deafness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 463 at risk

Adverse event: Deafness neurosensory
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 463 at risk

Adverse event: Goitre
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 463 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 463 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 463 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 463 at risk

Adverse event: Macular degeneration
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 463 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 463 at risk

Adverse event: Diverticulum
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 463 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 463 at risk

Adverse event: Gastric mucosal lesion
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 463 at risk

Adverse event: Hiatus hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 463 at risk

Adverse event: Cyst
Serious: no
Organ System: General disorders
Frequency: 1 affected / 463 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 463 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 463 at risk

Adverse event: Genital herpes
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 463 at risk

Adverse event: Hand fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 463 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 463 at risk

Adverse event: Meniscus injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 463 at risk

Adverse event: Back injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 463 at risk

Adverse event: Joint dislocation
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 463 at risk

Adverse event: Heart rate irregular
Serious: no
Organ System: Investigations
Frequency: 1 affected / 463 at risk

Adverse event: Gout
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 463 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 463 at risk

Adverse event: Type 2 diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 463 at risk

Adverse event: Diabetic foot
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 463 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 463 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 463 at risk

Adverse event: Bursitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 463 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 463 at risk

Adverse event: Rotator cuff syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 463 at risk

Adverse event: Plantar fasciitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 463 at risk

Adverse event: Tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 463 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 463 at risk

Adverse event: Osteopenia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 463 at risk

Adverse event: Sacroiliitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 463 at risk

Adverse event: Trigger finger
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 463 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 463 at risk

Adverse event: Melanocytic naevus
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 463 at risk

Adverse event: Bladder neoplasm
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 463 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 463 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 463 at risk

Adverse event: Amnesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 463 at risk

Adverse event: Dementia Alzheimer's type
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 463 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 463 at risk

Adverse event: Senile dementia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 463 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 463 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 463 at risk

Adverse event: Hypertonic bladder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 463 at risk

Adverse event: Renal artery occlusion
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 463 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 463 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 463 at risk

Adverse event: Sleep apnoea syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 463 at risk

Adverse event: Emphysema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 463 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 463 at risk

Adverse event: Actinic keratosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 463 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 463 at risk

Adverse event: Eczema asteatotic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 463 at risk

Adverse event: Lichenoid keratosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 463 at risk

Adverse event: Skin lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 463 at risk

Adverse event: Skin wrinkling
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 463 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 463 at risk

Adverse event: Peripheral vascular disorder
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 463 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 473 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 473 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 473 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 473 at risk

Adverse event: Hyperthyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 473 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 473 at risk

Adverse event: Abdominal mass
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 473 at risk

Adverse event: Large intestinal stenosis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 473 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 473 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 473 at risk

Adverse event: Small intestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 473 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 473 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 473 at risk

Adverse event: Labyrinthitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 473 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 473 at risk

Adverse event: Post procedural pulmonary embolism
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 473 at risk

Adverse event: Wrist fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 473 at risk

Adverse event: Gout
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 473 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 473 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 473 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 473 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 473 at risk

Adverse event: Squamous cell carcinoma of skin
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 473 at risk

Adverse event: B-cell lymphoma recurrent
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 473 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 473 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 473 at risk

Adverse event: Neuroendocrine carcinoma of the skin
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 473 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 473 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 473 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 473 at risk

Adverse event: Uterovaginal prolapse
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 473 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 473 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 473 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 473 at risk

Adverse event: Coronary artery disease
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 473 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 473 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 473 at risk

Adverse event: Deafness neurosensory
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 473 at risk

Adverse event: Hyperparathyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 473 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 473 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 473 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 473 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 473 at risk

Adverse event: Barrett's oesophagus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 473 at risk

Adverse event: Coeliac disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 473 at risk

Adverse event: Gastric polyps
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 473 at risk

Adverse event: Oesophageal ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 473 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 473 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 473 at risk

Adverse event: Gait disturbance
Serious: no
Organ System: General disorders
Frequency: 1 affected / 473 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 473 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 473 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 473 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 473 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 473 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 473 at risk

Adverse event: Staphylococcal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 473 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 473 at risk

Adverse event: Meniscus injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 473 at risk

Adverse event: Factured sacrum
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 473 at risk

Adverse event: Skin injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 473 at risk

Adverse event: Prostatic specific antigen increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 473 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 473 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 473 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 473 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 473 at risk

Adverse event: Type 1 diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 473 at risk

Adverse event: Vitamin D deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 473 at risk

Adverse event: Fluid retention
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 473 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 473 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 473 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 473 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 473 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 473 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 473 at risk

Adverse event: Spinal stenosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 473 at risk

Adverse event: Plantar fasciitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 473 at risk

Adverse event: Dupuytren's contracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 473 at risk

Adverse event: Synovial cyst
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 473 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 473 at risk

Adverse event: Lipoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 473 at risk

Adverse event: Benign breast neoplasm
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 473 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 473 at risk

Adverse event: Amnesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 473 at risk

Adverse event: Anosmia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 473 at risk

Adverse event: Restless legs syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 473 at risk

Adverse event: Chronic kidney disease
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 473 at risk

Adverse event: Urethral stenosis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 473 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 473 at risk

Adverse event: Benign prostatic hyperplasia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 473 at risk

Adverse event: Breast mass
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 473 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 473 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 473 at risk

Adverse event: Sleep apnoea syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 473 at risk

Adverse event: Diaphragmatic hernia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 473 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 473 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 473 at risk

Adverse event: Rosacea
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 473 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 473 at risk

Adverse event: Aortic disorder
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 473 at risk

Adverse event: Vasoconstriction
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 473 at risk

Adverse event: Peripheral venous disease
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 473 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 391 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 391 at risk

Adverse event: Cholecystitis chronic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 391 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 391 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 391 at risk

Adverse event: Coronary artery disease
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 391 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 391 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 391 at risk

Adverse event: Keratitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 391 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 391 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 391 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 391 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 391 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 391 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 391 at risk

Adverse event: Swollen tongue
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 391 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 391 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 3 affected / 391 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 391 at risk

Adverse event: Vaccination site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 391 at risk

Adverse event: Inflammation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 391 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 391 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 391 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 391 at risk

Adverse event: Allergy to arthropod sting
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 391 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 391 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 391 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 391 at risk

Adverse event: Eye infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 391 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 391 at risk

Adverse event: Fungal skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 391 at risk

Adverse event: Otitis externa
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 391 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 391 at risk

Adverse event: Ligament rupture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 391 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 391 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 391 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 391 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 391 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 391 at risk

Adverse event: Red blood cell sedimentation rate increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 391 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 391 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 391 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 391 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 391 at risk

Adverse event: Rotator cuff syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 391 at risk

Adverse event: Spinal stenosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 391 at risk

Adverse event: Plantar fasciitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 391 at risk

Adverse event: Tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 391 at risk

Adverse event: Seborrhoeic keratosis
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 391 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 391 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 391 at risk

Adverse event: Hemianopia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 391 at risk

Adverse event: Loss of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 391 at risk

Adverse event: Narcolepsy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 391 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 391 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 391 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 391 at risk

Adverse event: Breast calcification
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 391 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 391 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 391 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 391 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 391 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 391 at risk

Adverse event: Actinic keratosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 391 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 391 at risk

Adverse event: Pruritus generalising
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 391 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 391 at risk

Adverse event: Peripheral venous disease
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 391 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 30 affected / 236 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 16 affected / 233 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 16 affected / 231 at risk

Adverse event: Redness (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 4 affected / 227 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 29 affected / 236 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 24 affected / 234 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 8 affected / 229 at risk

Adverse event: Swelling (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 2 affected / 227 at risk

Adverse event: Pain (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 173 affected / 297 at risk

Adverse event: Pain (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 158 affected / 291 at risk

Adverse event: Pain (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 31 affected / 239 at risk

Adverse event: Pain (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 1 affected / 226 at risk

Adverse event: Limitation of arm movement (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 40 affected / 247 at risk

Adverse event: Limitation of arm movement (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 38 affected / 245 at risk

Adverse event: Limitation of arm movement (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 2 affected / 228 at risk

Adverse event: Limitation of arm movement (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 2 affected / 228 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 23 affected / 185 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 11 affected / 182 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 13 affected / 182 at risk

Adverse event: Redness (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 3 affected / 179 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 20 affected / 185 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 16 affected / 182 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 5 affected / 179 at risk

Adverse event: Pain (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 148 affected / 258 at risk

Adverse event: Pain (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 136 affected / 251 at risk

Adverse event: Pain (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 21 affected / 187 at risk

Adverse event: Pain (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 1 affected / 179 at risk

Adverse event: Limitation of arm movement (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 26 affected / 195 at risk

Adverse event: Limitation of arm movement (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 26 affected / 194 at risk

Adverse event: Limitation of arm movement (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 1 affected / 178 at risk

Adverse event: Fever (Any) ≥ 38 degrees Celsius (C)
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 8 affected / 229 at risk

Adverse event: Fever (Mild) ≥ 38 degrees but < 38.5 degrees C
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 2 affected / 227 at risk

Adverse event: Fever (Moderate) ≥ 38.5 degrees but < 39 degrees C
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 2 affected / 227 at risk

Adverse event: Fever (Severe) ≥ 39 degrees but ≤ 40 degrees C
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 1 affected / 226 at risk

Adverse event: Fever (Potentially life threatening) > 40 degrees C
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 3 affected / 227 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 73 affected / 255 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 47 affected / 246 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 17 affected / 234 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 14 affected / 232 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 1 affected / 226 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 21 affected / 237 at risk

Adverse event: New generalized muscle pain
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 90 affected / 260 at risk

Adverse event: Aggravated generalized muscle pain
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 44 affected / 245 at risk

Adverse event: New generalized joint pain
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 25 affected / 238 at risk

Adverse event: Aggravated generalized joint pain
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 30 affected / 239 at risk

Adverse event: Fever (Any) ≥ 38 degrees C
Serious: no
Organ System: General disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 4 affected / 179 at risk

Adverse event: Fever (Mild) ≥ 38 degrees but < 38.5 degrees C
Serious: no
Organ System: General disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 1 affected / 179 at risk

Adverse event: Fever (Severe) ≥ 39 degrees but ≤ 40 degrees C
Serious: no
Organ System: General disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 1 affected / 177 at risk

Adverse event: Fever (Potentially life threatening) > 40 degrees C
Serious: no
Organ System: General disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 2 affected / 177 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 61 affected / 215 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 38 affected / 200 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 8 affected / 182 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 11 affected / 183 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 15 affected / 190 at risk

Adverse event: New generalized muscle pain
Serious: no
Organ System: General disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 78 affected / 219 at risk

Adverse event: Aggravated generalized muscle pain
Serious: no
Organ System: General disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 32 affected / 198 at risk

Adverse event: New generalized joint pain
Serious: no
Organ System: General disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 14 affected / 187 at risk

Adverse event: Aggravated generalized joint pain
Serious: no
Organ System: General disorders
Notes: 13vPnC (Vax 1 / Year 0) and 13vPnC / 13vPnC (Vax 2 / Year 1)
Frequency: 19 affected / 188 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 404 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 404 at risk

Adverse event: Muscle rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 404 at risk

Adverse event: Spinal fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 404 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 404 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 404 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 404 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 404 at risk

Adverse event: Lumbar spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 404 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 404 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 404 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 404 at risk

Adverse event: Ear discomfort
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 404 at risk

Adverse event: Hypermetropia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 404 at risk

Adverse event: Astigmatism
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 404 at risk

Adverse event: Presbyopia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 404 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 404 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 404 at risk

Adverse event: Anal incontinence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 404 at risk

Adverse event: Food poisoning
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 404 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 404 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 3 affected / 404 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 404 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 404 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 404 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 404 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 404 at risk

Adverse event: Diverticulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 404 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 404 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 404 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 404 at risk

Adverse event: Skin infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 404 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 404 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 404 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 404 at risk

Adverse event: Skin injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 404 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 404 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 404 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 404 at risk

Adverse event: Arthropod sting
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 404 at risk

Adverse event: Foot fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 404 at risk

Adverse event: Joint injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 404 at risk

Adverse event: Heart rate irregular
Serious: no
Organ System: Investigations
Frequency: 1 affected / 404 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 404 at risk

Adverse event: Faecal occult blood positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 404 at risk

Adverse event: Gout
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 404 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 404 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 404 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 404 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 404 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 404 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 404 at risk

Adverse event: Spinal stenosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 404 at risk

Adverse event: Plantar fasciitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 404 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 404 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 404 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 404 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 404 at risk

Adverse event: Nervousness
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 404 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 404 at risk

Adverse event: Bladder spasm
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 404 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 404 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 404 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 404 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 404 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 404 at risk

Adverse event: Upper respiratory tract congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 404 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 404 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 404 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 404 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 404 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 404 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 23 affected / 228 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 20 affected / 226 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 8 affected / 223 at risk

Adverse event: Redness (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 2 affected / 222 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 34 affected / 241 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 28 affected / 236 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 11 affected / 229 at risk

Adverse event: Swelling (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 1 affected / 222 at risk

Adverse event: Pain (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 171 affected / 302 at risk

Adverse event: Pain (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 159 affected / 297 at risk

Adverse event: Pain (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 31 affected / 236 at risk

Adverse event: Pain (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 2 affected / 221 at risk

Adverse event: Limitation of arm movement (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 50 affected / 251 at risk

Adverse event: Limitation of arm movement (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 47 affected / 249 at risk

Adverse event: Limitation of arm movement (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 2 affected / 222 at risk

Adverse event: Limitation of arm movement (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 3 affected / 222 at risk

Adverse event: Fever (Any) ≥ 38 degrees Celsius (C)
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 5 affected / 224 at risk

Adverse event: Fever (Mild) ≥ 38 degrees but < 38.5 degrees C
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 4 affected / 224 at risk

Adverse event: Fever (Severe) ≥ 39 degrees but ≤ 40 degrees C
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 1 affected / 222 at risk

Adverse event: Fever (Potentially life threatening) > 40 degrees C
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 1 affected / 221 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 91 affected / 265 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 56 affected / 248 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 23 affected / 233 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 16 affected / 226 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 7 affected / 226 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 17 affected / 230 at risk

Adverse event: New generalized muscle pain
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 92 affected / 263 at risk

Adverse event: Aggravated generalized muscle pain
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 52 affected / 248 at risk

Adverse event: New generalized joint pain
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 28 affected / 234 at risk

Adverse event: Aggravated generalized joint pain
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS (Vax 1 / Year 0); 13vPnC / 13vPnC and 23vPS / 13vPnC (Vax 2/ Year 1)
Frequency: 27 affected / 231 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 391 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 391 at risk

Adverse event: Arteriosclerosis coronary artery
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 391 at risk

Adverse event: Sinus arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 391 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 391 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 391 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 391 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 391 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 391 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 391 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 391 at risk

Adverse event: Bowen's disease
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 391 at risk

Adverse event: Breast cancer in situ
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 391 at risk

Adverse event: Gastrointestinal tract adenoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 391 at risk

Adverse event: Metastatic neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 391 at risk

Adverse event: Non-small cell lung cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 391 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 391 at risk

Adverse event: Benign prostatic hyperplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 391 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 391 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 391 at risk

Adverse event: Coronary artery disease
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 391 at risk

Adverse event: Hypertensive heart disease
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 391 at risk

Adverse event: Cerumen impaction
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 391 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 391 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 391 at risk

Adverse event: Large intestine polyp
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 391 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 391 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 391 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 391 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 391 at risk

Adverse event: Wound
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 391 at risk

Adverse event: Upper limb fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 391 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 391 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 391 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 391 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 391 at risk

Adverse event: Plantar fasciitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 391 at risk

Adverse event: Dupuytren's contracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 391 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 391 at risk

Adverse event: Amnesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 391 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 391 at risk

Adverse event: Restless legs syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 391 at risk

Adverse event: Hypertonia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 391 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 391 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 391 at risk

Adverse event: Renal artery arteriosclerosis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 391 at risk

Adverse event: Bladder neck obstruction
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 391 at risk

Adverse event: Stress urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 391 at risk

Adverse event: Prostatomegaly
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 391 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 391 at risk

Adverse event: Aortic stenosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 391 at risk

Adverse event: Immune thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 404 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 404 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 404 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 404 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 404 at risk

Adverse event: Diverticular perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 404 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 404 at risk

Adverse event: Subileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 404 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 404 at risk

Adverse event: Gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 404 at risk

Adverse event: Atypical pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 404 at risk

Adverse event: Pneumonia viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 404 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 404 at risk

Adverse event: Compression fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 404 at risk

Adverse event: Squamous cell carcinoma of skin
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 404 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 404 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 404 at risk

Adverse event: Bowen's disease
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 404 at risk

Adverse event: Laryngeal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 404 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 404 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 404 at risk

Adverse event: Orthopnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 404 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 404 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 404 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 404 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 404 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 404 at risk

Adverse event: Atrioventricular block first degree
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 404 at risk

Adverse event: Sinus node dysfunction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 404 at risk

Adverse event: Deafness
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 404 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 404 at risk

Adverse event: Open angle glaucoma
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 404 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 404 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 404 at risk

Adverse event: Staphylococcal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 404 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 404 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 404 at risk

Adverse event: Bursitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 404 at risk

Adverse event: Rotator cuff syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 404 at risk

Adverse event: Spinal stenosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 404 at risk

Adverse event: Plantar fasciitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 404 at risk

Adverse event: Dupuytren's contracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 404 at risk

Adverse event: Synovial cyst
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 404 at risk

Adverse event: Benign neoplasm of thyroid gland
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 404 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 404 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 404 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 404 at risk

Adverse event: Post herpetic neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 404 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 404 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 404 at risk

Adverse event: Renal impairment
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 404 at risk

Adverse event: Benign prostatic hyperplasia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 404 at risk

Adverse event: Sleep apnoea syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 404 at risk

Adverse event: Bronchial hyperreactivity
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 404 at risk

Adverse event: Nasal septum perforation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 404 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 404 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 404 at risk

Adverse event: Peripheral venous disease
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 404 at risk