Study: NCT00427895

Adverse event: Haemangioma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 417 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 39 affected / 193 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 30 affected / 189 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 185 at risk

Adverse event: Redness (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 178 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 38 affected / 197 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 30 affected / 192 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 184 at risk

Adverse event: Swelling (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 178 at risk

Adverse event: Pain (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 265 affected / 331 at risk

Adverse event: Pain (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 254 affected / 323 at risk

Adverse event: Pain (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 48 affected / 206 at risk

Adverse event: Pain (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 178 at risk

Adverse event: Limitation of arm movement (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 61 affected / 214 at risk

Adverse event: Limitation of arm movement (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 57 affected / 212 at risk

Adverse event: Limitation of arm movement (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 179 at risk

Adverse event: Limitation of arm movement (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 180 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 175 affected / 277 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 136 affected / 252 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 48 affected / 204 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Frequency: 32 affected / 194 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 7 affected / 180 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 43 affected / 202 at risk

Adverse event: New generalized muscle pain
Serious: no
Organ System: General disorders
Frequency: 140 affected / 249 at risk

Adverse event: Aggravated generalized muscle pain
Serious: no
Organ System: General disorders
Frequency: 70 affected / 215 at risk

Adverse event: New generalized joint pain
Serious: no
Organ System: General disorders
Frequency: 48 affected / 197 at risk

Adverse event: Aggravated generalized joint pain
Serious: no
Organ System: General disorders
Frequency: 51 affected / 205 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 417 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 417 at risk

Adverse event: Tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 417 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 417 at risk

Adverse event: Ear congestion
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 417 at risk

Adverse event: Ear discomfort
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 417 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 417 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 417 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 417 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 417 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 417 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 417 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 417 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 417 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 417 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 417 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 417 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 417 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 417 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 417 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 417 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 417 at risk

Adverse event: Bacterial infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 417 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 417 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 417 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 417 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 417 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 417 at risk

Adverse event: Staphylococcal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 417 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 417 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 417 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 417 at risk

Adverse event: Lower limb fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 417 at risk

Adverse event: Rib fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 417 at risk

Adverse event: Prostatic specific antigen increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 417 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 417 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 417 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 417 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 417 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 417 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 417 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 417 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 417 at risk

Adverse event: Benign breast neoplasm
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 417 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 417 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 417 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 417 at risk

Adverse event: Depressive symptom
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 417 at risk

Adverse event: Testicular pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 417 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 417 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 417 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 417 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 417 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 417 at risk

Adverse event: Diaphragmalgia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 417 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 417 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 417 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 417 at risk

Adverse event: Petechiae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 417 at risk

Adverse event: Precancerous skin lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 417 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 417 at risk

Adverse event: Fever Any (>=38 degrees C)
Serious: no
Organ System: General disorders
Frequency: 14 affected / 181 at risk

Adverse event: Fever Mild (>=38 degrees C but <38.5 degrees C)
Serious: no
Organ System: General disorders
Frequency: 7 affected / 179 at risk

Adverse event: Fever Moderate (>=38.5 degrees C but <39 degrees C)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 178 at risk

Adverse event: Fever Potentially life threatening (>40 degrees C)
Serious: no
Organ System: General disorders
Notes: All reports of fever \>40 degrees C in 13vPnC and 23vPS for Cohort 1 were confirmed as data entry errors.
Frequency: 8 affected / 180 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 417 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 417 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 417 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 417 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 417 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 417 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 417 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 417 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 417 at risk

Adverse event: Spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 417 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 417 at risk

Adverse event: Hepatic cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 417 at risk

Adverse event: Pancreatic carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 417 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 417 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 414 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 414 at risk

Adverse event: Procedural pain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 414 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 414 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 27 affected / 190 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 21 affected / 187 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 182 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 25 affected / 191 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 189 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 181 at risk

Adverse event: Swelling (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 180 at risk

Adverse event: Pain (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 221 affected / 301 at risk

Adverse event: Pain (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 199 affected / 290 at risk

Adverse event: Pain (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 63 affected / 210 at risk

Adverse event: Pain (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 187 at risk

Adverse event: Limitation of arm movement (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 65 affected / 211 at risk

Adverse event: Limitation of arm movement (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 61 affected / 208 at risk

Adverse event: Limitation of arm movement (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 182 at risk

Adverse event: Limitation of arm movement (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 185 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 168 affected / 273 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 141 affected / 259 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 48 affected / 199 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Frequency: 25 affected / 192 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 10 affected / 186 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 45 affected / 207 at risk

Adverse event: New generalized muscle pain
Serious: no
Organ System: General disorders
Frequency: 155 affected / 268 at risk

Adverse event: Aggravated generalized muscle pain
Serious: no
Organ System: General disorders
Frequency: 84 affected / 225 at risk

Adverse event: New generalized joint pain
Serious: no
Organ System: General disorders
Frequency: 65 affected / 216 at risk

Adverse event: Aggravated generalized joint pain
Serious: no
Organ System: General disorders
Frequency: 44 affected / 206 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 414 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 414 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 414 at risk

Adverse event: Ear congestion
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 414 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 414 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 414 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 414 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 414 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 414 at risk

Adverse event: Chapped lips
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 414 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 414 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 414 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 414 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 414 at risk

Adverse event: Adverse drug reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 414 at risk

Adverse event: Axillary pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 414 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 414 at risk

Adverse event: Injection site injury
Serious: no
Organ System: General disorders
Frequency: 1 affected / 414 at risk

Adverse event: Injury associated with device
Serious: no
Organ System: General disorders
Frequency: 1 affected / 414 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 414 at risk

Adverse event: Mass
Serious: no
Organ System: General disorders
Frequency: 1 affected / 414 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 414 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 414 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 414 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 414 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 414 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 414 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 414 at risk

Adverse event: Localised infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 414 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 414 at risk

Adverse event: Gingivitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 414 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 414 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 414 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 414 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 414 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 414 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 414 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 414 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 414 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 414 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 414 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 414 at risk

Adverse event: Pain in jaw
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 414 at risk

Adverse event: Rotator cuff syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 414 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 414 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 414 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 414 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 414 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 414 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 414 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 414 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 414 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 414 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 414 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 414 at risk

Adverse event: Paranasal sinus hypersecretion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 414 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 414 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 414 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 414 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 414 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 414 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 414 at risk

Adverse event: Swelling face
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 414 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 414 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 414 at risk

Adverse event: Fever Any (>=38 degrees C)
Serious: no
Organ System: General disorders
Frequency: 11 affected / 185 at risk

Adverse event: Fever Mild (>=38 degrees C but <38.5 degrees C)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 180 at risk

Adverse event: Fever Potentially life threatening (>40 degrees C)
Serious: no
Organ System: General disorders
Notes: All reports of fever \>40 degrees C in 13vPnC and 23vPS for Cohort 1 were confirmed as data entry errors.
Frequency: 9 affected / 184 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 414 at risk

Adverse event: Abdominal mass
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 414 at risk

Adverse event: Crohn's disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 414 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 414 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 414 at risk

Adverse event: Biliary obstruction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 414 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 414 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 414 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 414 at risk

Adverse event: Bipolar disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 414 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 414 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 414 at risk

Adverse event: Lymphadenitis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 414 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 414 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 414 at risk

Adverse event: Head injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 414 at risk

Adverse event: Procedural dizziness
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 414 at risk

Adverse event: Tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 414 at risk

Adverse event: Aphonia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 414 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 403 at risk

Adverse event: Ovarian cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 403 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 24 affected / 152 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 23 affected / 151 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 140 at risk

Adverse event: Redness (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 137 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 35 affected / 161 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 33 affected / 160 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 138 at risk

Adverse event: Pain (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 286 affected / 322 at risk

Adverse event: Pain (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 263 affected / 306 at risk

Adverse event: Pain (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 75 affected / 190 at risk

Adverse event: Pain (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 139 at risk

Adverse event: Limitation of arm movement (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 79 affected / 194 at risk

Adverse event: Limitation of arm movement (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 73 affected / 189 at risk

Adverse event: Limitation of arm movement (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 140 at risk

Adverse event: Limitation of arm movement (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 139 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 157 affected / 248 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 162 affected / 246 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 31 affected / 158 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Frequency: 21 affected / 148 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 10 affected / 144 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 42 affected / 166 at risk

Adverse event: New generalized muscle pain
Serious: no
Organ System: General disorders
Frequency: 147 affected / 238 at risk

Adverse event: Aggravated generalized muscle pain
Serious: no
Organ System: General disorders
Frequency: 75 affected / 188 at risk

Adverse event: New generalized joint pain
Serious: no
Organ System: General disorders
Frequency: 52 affected / 165 at risk

Adverse event: Aggravated generalized joint pain
Serious: no
Organ System: General disorders
Frequency: 43 affected / 168 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 403 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 403 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 403 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 403 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 403 at risk

Adverse event: Abdominal pain lower
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 403 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 403 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 403 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 2 affected / 403 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 2 affected / 403 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 403 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 403 at risk

Adverse event: Vessel puncture site haematoma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 403 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 403 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 403 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 403 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 403 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 403 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 403 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 403 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 403 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 403 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 403 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 403 at risk

Adverse event: Acarodermatitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 403 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 403 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 403 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 403 at risk

Adverse event: Arthropod sting
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 403 at risk

Adverse event: Skin injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 403 at risk

Adverse event: Tendon rupture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 403 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 403 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 403 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 403 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 403 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 403 at risk

Adverse event: Tenosynovitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 403 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 403 at risk

Adverse event: Paranasal sinus hypersecretion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 403 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 403 at risk

Adverse event: Pulmonary congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 403 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 403 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 403 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 403 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 403 at risk

Adverse event: Fever Any (>=38 degrees C)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 137 at risk

Adverse event: Fever Mild (>=38 degrees C but <38.5 degrees C)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 137 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 403 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 403 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 403 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 403 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 403 at risk

Adverse event: Meningioma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 403 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 403 at risk

Adverse event: Lymphadenectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 403 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 403 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 403 at risk

Adverse event: Joint injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 403 at risk

Adverse event: Joint stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 403 at risk

Adverse event: Muscle tightness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 403 at risk

Adverse event: Erythema multiforme
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 108 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 50 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 50 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 48 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 53 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 52 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 49 at risk

Adverse event: Pain (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 62 affected / 79 at risk

Adverse event: Pain (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 58 affected / 76 at risk

Adverse event: Pain (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 53 at risk

Adverse event: Pain (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 48 at risk

Adverse event: Limitation of arm movement (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 54 at risk

Adverse event: Limitation of arm movement (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 54 at risk

Adverse event: Limitation of arm movement (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 47 at risk

Adverse event: Limitation of arm movement (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 47 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 35 affected / 69 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 23 affected / 60 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 12 affected / 52 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Frequency: 12 affected / 51 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 4 affected / 48 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 11 affected / 52 at risk

Adverse event: New generalized muscle pain
Serious: no
Organ System: General disorders
Frequency: 33 affected / 60 at risk

Adverse event: Aggravated generalized muscle pain
Serious: no
Organ System: General disorders
Frequency: 14 affected / 51 at risk

Adverse event: New generalized joint pain
Serious: no
Organ System: General disorders
Frequency: 10 affected / 53 at risk

Adverse event: Aggravated generalized joint pain
Serious: no
Organ System: General disorders
Frequency: 7 affected / 51 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 108 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 108 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 108 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 108 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 108 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 108 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 108 at risk

Adverse event: Clostridial infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 108 at risk

Adverse event: Pyelonephritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 108 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 108 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 108 at risk

Adverse event: Upper limb fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 108 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 108 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 108 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 108 at risk

Adverse event: Nipple exudate bloody
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 108 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 108 at risk

Adverse event: Upper-airway cough syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 108 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 108 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 108 at risk

Adverse event: Erythema multiforme
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 108 at risk

Adverse event: Fever Any (>=38 degrees C)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 48 at risk

Adverse event: Fever Moderate (>=38.5 degrees C but <39 degrees C)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 48 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 108 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 108 at risk

Adverse event: Deafness bilateral
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 108 at risk

Adverse event: Ligament rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 108 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 51 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 49 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 44 at risk

Adverse event: Redness (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 42 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 49 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 48 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 43 at risk

Adverse event: Swelling (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 42 at risk

Adverse event: Pain (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 73 affected / 87 at risk

Adverse event: Pain (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 68 affected / 83 at risk

Adverse event: Pain (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 26 affected / 59 at risk

Adverse event: Pain (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 44 at risk

Adverse event: Limitation of arm movement (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 24 affected / 57 at risk

Adverse event: Limitation of arm movement (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 23 affected / 57 at risk

Adverse event: Limitation of arm movement (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 43 at risk

Adverse event: Limitation of arm movement (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 41 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 43 affected / 68 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 32 affected / 64 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 19 affected / 56 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Frequency: 9 affected / 49 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 2 affected / 43 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 17 affected / 54 at risk

Adverse event: New generalized muscle pain
Serious: no
Organ System: General disorders
Frequency: 43 affected / 66 at risk

Adverse event: Aggravated generalized muscle pain
Serious: no
Organ System: General disorders
Frequency: 24 affected / 58 at risk

Adverse event: New generalized joint pain
Serious: no
Organ System: General disorders
Frequency: 13 affected / 53 at risk

Adverse event: Aggravated generalized joint pain
Serious: no
Organ System: General disorders
Frequency: 11 affected / 49 at risk

Adverse event: Herpes simplex
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 108 at risk

Adverse event: Ear congestion
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 108 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 108 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 108 at risk

Adverse event: Inguinal hernia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 108 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 108 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 108 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 108 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 108 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 108 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 108 at risk

Adverse event: Hordeolum
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 108 at risk

Adverse event: Tooth abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 108 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 108 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 108 at risk

Adverse event: Melanocytic naevus
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 108 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 108 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 108 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 108 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 108 at risk

Adverse event: Fever Any (>=38 degrees C)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 43 at risk

Adverse event: Fever Mild (>=38 degrees C but <38.5 degrees C)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 42 at risk

Adverse event: Fever Moderate (>=38.5 degrees C but <39 degrees C)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 42 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 108 at risk

Adverse event: Cataract
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 108 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 108 at risk

Adverse event: Diverticulum
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 108 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 108 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 39 affected / 109 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 28 affected / 101 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 91 at risk

Adverse event: Redness (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 85 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 37 affected / 104 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 91 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 23 affected / 95 at risk

Adverse event: Swelling (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 82 at risk

Adverse event: Pain (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 139 affected / 164 at risk

Adverse event: Pain (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 125 affected / 156 at risk

Adverse event: Pain (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 57 affected / 111 at risk

Adverse event: Pain (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 86 at risk

Adverse event: Limitation of arm movement (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 54 affected / 112 at risk

Adverse event: Limitation of arm movement (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 51 affected / 110 at risk

Adverse event: Limitation of arm movement (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 81 at risk

Adverse event: Limitation of arm movement (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 84 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 72 affected / 125 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 64 affected / 118 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 34 affected / 99 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Frequency: 31 affected / 95 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 1 affected / 79 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 22 affected / 93 at risk

Adverse event: New generalized muscle pain
Serious: no
Organ System: General disorders
Frequency: 92 affected / 136 at risk

Adverse event: Aggravated generalized muscle pain
Serious: no
Organ System: General disorders
Frequency: 40 affected / 101 at risk

Adverse event: New generalized joint pain
Serious: no
Organ System: General disorders
Frequency: 21 affected / 91 at risk

Adverse event: Aggravated generalized joint pain
Serious: no
Organ System: General disorders
Frequency: 16 affected / 91 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 189 at risk

Adverse event: Joint injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 189 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 189 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 189 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 189 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 189 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 189 at risk

Adverse event: Injection site pallor
Serious: no
Organ System: General disorders
Frequency: 1 affected / 189 at risk

Adverse event: Injection site rash
Serious: no
Organ System: General disorders
Frequency: 1 affected / 189 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 189 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 189 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 189 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 189 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 189 at risk

Adverse event: Diverticulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 189 at risk

Adverse event: Skin candida
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 189 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 189 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 189 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 189 at risk

Adverse event: Ligament rupture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 189 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 189 at risk

Adverse event: Gout
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 189 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 189 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 189 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 189 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 189 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 189 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 189 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 189 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 189 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 189 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 189 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 189 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 189 at risk

Adverse event: Fever Any (>=38 degrees C)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 79 at risk

Adverse event: Fever Mild (>=38 degrees C but <38.5 degrees C)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 79 at risk

Adverse event: Lumbar vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 189 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 189 at risk

Adverse event: Endometrial cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 189 at risk

Adverse event: Nystagmus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 189 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 189 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 189 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 189 at risk

Adverse event: Tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 189 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 189 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 189 at risk

Adverse event: Dementia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 189 at risk

Adverse event: Generalised anxiety disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 189 at risk

Adverse event: Chronic kidney disease
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 189 at risk

Adverse event: Breast mass
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 189 at risk

Adverse event: Rosacea
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 189 at risk

Adverse event: Rash pruritic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 189 at risk

Adverse event: Peripheral venous disease
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 189 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 189 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 84 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 15 affected / 83 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 75 at risk

Adverse event: Redness (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 73 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 84 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 84 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 73 at risk

Adverse event: Swelling (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 73 at risk

Adverse event: Pain (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 161 affected / 173 at risk

Adverse event: Pain (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 150 affected / 165 at risk

Adverse event: Pain (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 60 affected / 112 at risk

Adverse event: Pain (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 75 at risk

Adverse event: Limitation of arm movement (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 56 affected / 109 at risk

Adverse event: Limitation of arm movement (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 51 affected / 106 at risk

Adverse event: Limitation of arm movement (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 77 at risk

Adverse event: Limitation of arm movement (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 77 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 76 affected / 125 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 76 affected / 123 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 24 affected / 93 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Frequency: 11 affected / 81 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 3 affected / 76 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 22 affected / 89 at risk

Adverse event: New generalized muscle pain
Serious: no
Organ System: General disorders
Frequency: 89 affected / 128 at risk

Adverse event: Aggravated generalized muscle pain
Serious: no
Organ System: General disorders
Frequency: 33 affected / 95 at risk

Adverse event: New generalized joint pain
Serious: no
Organ System: General disorders
Frequency: 31 affected / 93 at risk

Adverse event: Aggravated generalized joint pain
Serious: no
Organ System: General disorders
Frequency: 22 affected / 88 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 214 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 214 at risk

Adverse event: Large intestine polyp
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 214 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 214 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 214 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 214 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 214 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 214 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 214 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 214 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 214 at risk

Adverse event: Tinea infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 214 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 214 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 214 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 214 at risk

Adverse event: Neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 214 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 214 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 214 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 214 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 214 at risk

Adverse event: Precancerous skin lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 214 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 214 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 214 at risk

Adverse event: Fever Any (>=38 degrees C)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 75 at risk

Adverse event: Fever Mild (>=38 degrees C but <38.5 degrees C)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 75 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 214 at risk

Adverse event: Herpes simplex
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 214 at risk

Adverse event: Atrophic vulvovaginitis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 214 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 214 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 899 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 899 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 81 affected / 266 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 68 affected / 258 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 27 affected / 227 at risk

Adverse event: Redness (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 211 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 119 affected / 302 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 109 affected / 293 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 36 affected / 238 at risk

Adverse event: Swelling (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 209 at risk

Adverse event: Pain (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 761 affected / 787 at risk

Adverse event: Pain (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 672 affected / 721 at risk

Adverse event: Pain (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 360 affected / 467 at risk

Adverse event: Pain (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 38 affected / 238 at risk

Adverse event: Limitation of arm movement (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 375 affected / 499 at risk

Adverse event: Limitation of arm movement (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 333 affected / 466 at risk

Adverse event: Limitation of arm movement (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 44 affected / 238 at risk

Adverse event: Limitation of arm movement (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 37 affected / 237 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 446 affected / 554 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 429 affected / 527 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 109 affected / 286 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Frequency: 53 affected / 249 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 36 affected / 240 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 202 affected / 363 at risk

Adverse event: New generalized muscle pain
Serious: no
Organ System: General disorders
Frequency: 460 affected / 561 at risk

Adverse event: Aggravated generalized muscle pain
Serious: no
Organ System: General disorders
Frequency: 207 affected / 370 at risk

Adverse event: New generalized joint pain
Serious: no
Organ System: General disorders
Frequency: 128 affected / 307 at risk

Adverse event: Aggravated generalized joint pain
Serious: no
Organ System: General disorders
Frequency: 77 affected / 269 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 899 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 899 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 899 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 899 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 899 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 899 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 899 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 899 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 899 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 2 affected / 899 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 899 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 899 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 899 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 899 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 899 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 899 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 899 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 899 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 899 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 899 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 899 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 899 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 899 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 899 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 899 at risk

Adverse event: Tooth abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 899 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 899 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 899 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 899 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 899 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 899 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 899 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 899 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 899 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 899 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 899 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 899 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 899 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 899 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 899 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 899 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 899 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 899 at risk

Adverse event: Upper-airway cough syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 899 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 899 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 899 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 899 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 899 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 899 at risk

Adverse event: Fever Any (>=38 degrees C)
Serious: no
Organ System: General disorders
Frequency: 16 affected / 221 at risk

Adverse event: Fever Mild (>=38 degrees C but <38.5 degrees C)
Serious: no
Organ System: General disorders
Frequency: 9 affected / 214 at risk

Adverse event: Fever Moderate (>=38.5 degrees C but <39 degrees C)
Serious: no
Organ System: General disorders
Frequency: 4 affected / 211 at risk

Adverse event: Fever Severe (>=39 degrees C but <=40 degrees C)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 210 at risk

Adverse event: Fever Potentially life threatening (>40 degrees C)
Serious: no
Organ System: General disorders
Notes: All reports of fever \>40 degrees C in 13vPnC and 23vPS for Cohort 1 were confirmed as data entry errors.
Frequency: 1 affected / 208 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 899 at risk

Adverse event: Lymph node pain
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 899 at risk

Adverse event: Cerumen impaction
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 899 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 899 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 899 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 899 at risk

Adverse event: Injection site warmth
Serious: no
Organ System: General disorders
Frequency: 4 affected / 899 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 3 affected / 899 at risk

Adverse event: Injection site irritation
Serious: no
Organ System: General disorders
Frequency: 2 affected / 899 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 899 at risk

Adverse event: Allergy to vaccine
Serious: no
Organ System: Immune system disorders
Frequency: 2 affected / 899 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 899 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 899 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 899 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 899 at risk

Adverse event: Heart rate increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 899 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 899 at risk

Adverse event: Polydipsia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 899 at risk

Adverse event: Medial tibial stress syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 899 at risk

Adverse event: Muscle twitching
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 899 at risk

Adverse event: Nerve compression
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 899 at risk

Adverse event: Neuritis
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 899 at risk

Adverse event: Tension headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 899 at risk

Adverse event: Mood altered
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 899 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 899 at risk

Adverse event: Bronchial hyperreactivity
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 899 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 899 at risk

Adverse event: Upper respiratory tract congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 899 at risk

Adverse event: Dermatitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 899 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 899 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 899 at risk

Adverse event: Hand fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 899 at risk

Adverse event: Bipolar disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 899 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 899 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 899 at risk

Adverse event: Ovarian cyst ruptured
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 899 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 899 at risk