Study: NCT00574548

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 478 at risk

Adverse event: Squamous cell carcinoma of skin
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 478 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 478 at risk

Adverse event: Cerumen impaction
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 478 at risk

Adverse event: Middle ear effusion
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 478 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 478 at risk

Adverse event: Eyelid pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 478 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 478 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 478 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 478 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 478 at risk

Adverse event: Large intestine polyp
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 478 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 478 at risk

Adverse event: Gingivitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 478 at risk

Adverse event: Haematochezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 478 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 4 affected / 478 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 3 affected / 478 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 478 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 478 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 478 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 478 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 478 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 478 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 478 at risk

Adverse event: Allergy to vaccine
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 478 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 478 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 478 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 478 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 478 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 478 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 478 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 478 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 478 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 478 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 478 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 478 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 478 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 478 at risk

Adverse event: Vascular injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 478 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 478 at risk

Adverse event: Blood pressure decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 478 at risk

Adverse event: Blood triglycerides increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 478 at risk

Adverse event: Body temperature decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 478 at risk

Adverse event: Haemoglobin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 478 at risk

Adverse event: Diabetic foot
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 478 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 478 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 478 at risk

Adverse event: Osteopenia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 478 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 478 at risk

Adverse event: Bursa disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 478 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 478 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 478 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 478 at risk

Adverse event: Synovial cyst
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 478 at risk

Adverse event: Tendon disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 478 at risk

Adverse event: Seborrhoeic keratosis
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 478 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 478 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 478 at risk

Adverse event: Sinus headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 478 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 478 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 478 at risk

Adverse event: Benign prostatic hyperplasia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 478 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 478 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 478 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 478 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 478 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 478 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 478 at risk

Adverse event: Bronchial hyperreactivity
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 478 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 478 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 478 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 478 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 478 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 478 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS Year 0; Redness (Any) redness present
Frequency: 33 affected / 270 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS Year 0; Redness (Mild) 2.5 to 5.0 cm
Frequency: 22 affected / 266 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS Year 0; Redness (Moderate) 5.1 to 10.0 cm
Frequency: 17 affected / 264 at risk

Adverse event: Redness (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS Year 0; Redness (Severe) \>10 cm
Frequency: 3 affected / 259 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS Year 0; Swelling (Any) swelling present
Frequency: 27 affected / 270 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS Year 0; Swelling (Mild) 2.5 to 5.0 cm
Frequency: 22 affected / 268 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS Year 0; Swelling (Moderate) 5.1 to 10.0 cm
Frequency: 10 affected / 263 at risk

Adverse event: Pain (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS Year 0; Pain (Any) pain present
Frequency: 256 affected / 370 at risk

Adverse event: Pain (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS Year 0; Pain (Mild) awareness of pain; easily tolerated
Frequency: 238 affected / 360 at risk

Adverse event: Pain (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS Year 0; Pain (Moderate) discomfort enough to cause interference with usual activity
Frequency: 57 affected / 284 at risk

Adverse event: Pain (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS Year 0; Pain (Severe) incapacitating
Frequency: 6 affected / 261 at risk

Adverse event: Limitation of arm movement (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS Year 0; Limitation of arm movement (Any) limitation present
Frequency: 68 affected / 289 at risk

Adverse event: Limitation of arm movement (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS Year 0; Limitation of arm movement (Mild) some limitation
Frequency: 65 affected / 286 at risk

Adverse event: Limitation of arm movement (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS Year 0; Limitation of arm movement (Moderate) unable to move arm above head; able to move arm above shoulder
Frequency: 3 affected / 260 at risk

Adverse event: Limitation of arm movement (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS Year 0; Limitation of arm movement (Severe) unable to move arm above shoulder
Frequency: 3 affected / 261 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); Redness (Any)
Frequency: 9 affected / 61 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); Redness (Mild)
Frequency: 4 affected / 57 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); Redness (Moderate)
Frequency: 5 affected / 58 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); Swelling (Any)
Frequency: 6 affected / 60 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); Swelling (Mild)
Frequency: 4 affected / 59 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); Swelling (Moderate)
Frequency: 1 affected / 55 at risk

Adverse event: Pain (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); Pain (Any)
Frequency: 83 affected / 108 at risk

Adverse event: Pain (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); Pain (Mild)
Frequency: 73 affected / 101 at risk

Adverse event: Pain (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); Pain (Moderate)
Frequency: 13 affected / 61 at risk

Adverse event: Limitation of arm movement (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); Limitation of arm movement (Any)
Frequency: 17 affected / 65 at risk

Adverse event: Limitation of arm movement (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); Limitation of arm movement (Mild)
Frequency: 17 affected / 65 at risk

Adverse event: Limitation of arm movement (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); Limitation of arm movement (Moderate)
Frequency: 1 affected / 56 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Redness (Any)
Frequency: 33 affected / 270 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Redness (Mild)
Frequency: 22 affected / 266 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Redness (Moderate)
Frequency: 17 affected / 264 at risk

Adverse event: Redness (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Redness (Severe)
Frequency: 3 affected / 259 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Swelling (Any)
Frequency: 27 affected / 270 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Swelling (Mild)
Frequency: 22 affected / 268 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Swelling (Moderate)
Frequency: 10 affected / 263 at risk

Adverse event: Pain (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Pain (Any)
Frequency: 256 affected / 370 at risk

Adverse event: Pain (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Pain (Mild)
Frequency: 238 affected / 360 at risk

Adverse event: Pain (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Pain (Moderate)
Frequency: 57 affected / 284 at risk

Adverse event: Pain (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Pain (Severe)
Frequency: 6 affected / 261 at risk

Adverse event: Limitation of arm movement (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Limitation of arm movement (Any)
Frequency: 68 affected / 289 at risk

Adverse event: Limitation of arm movement (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Limitation of arm movement (Mild)
Frequency: 65 affected / 286 at risk

Adverse event: Limitation of arm movement (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Limitation of arm movement (Moderate)
Frequency: 3 affected / 260 at risk

Adverse event: Limitation of arm movement (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Limitation of arm movement (Severe)
Frequency: 3 affected / 261 at risk

Adverse event: Fever (Any)
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS Year 0; Fever (Any) ≥38 degrees C
Frequency: 12 affected / 263 at risk

Adverse event: Fever (Mild)
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS Year 0; Fever (Mild) ≥38 but \<38.5 degrees C
Frequency: 10 affected / 263 at risk

Adverse event: Fever (Moderate)
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS Year 0; Fever (Moderate) ≥38.5 but \<39 degrees C
Frequency: 2 affected / 259 at risk

Adverse event: Fever (Severe)
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS Year 0; Fever (Severe) ≥39 but ≤40 degrees C
Frequency: 1 affected / 259 at risk

Adverse event: Fever (Potentially life threatening)
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS Year 0; Fever (Potentially life threatening) \>40C
Frequency: 1 affected / 258 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS Year 0; Fatigue
Frequency: 162 affected / 321 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS Year 0; Headache
Frequency: 163 affected / 328 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS Year 0; Chills
Frequency: 57 affected / 286 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS Year 0; Rash
Frequency: 23 affected / 267 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS Year 0; Vomiting
Frequency: 8 affected / 261 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS Year 0; Decreased appetite
Frequency: 41 affected / 278 at risk

Adverse event: New generalized muscle pain
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS Year 0; New generalized muscle pain
Frequency: 152 affected / 324 at risk

Adverse event: Aggravated generalized muscle pain
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS Year 0; Aggravated generalized muscle pain
Frequency: 63 affected / 286 at risk

Adverse event: New generalized joint pain
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS Year 0; New generalized joint pain
Frequency: 43 affected / 278 at risk

Adverse event: Aggravated generalized joint pain
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS Year 0; Aggravated generalized joint pain
Frequency: 38 affected / 272 at risk

Adverse event: Fever (Any)
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); Fever (Any)
Frequency: 5 affected / 55 at risk

Adverse event: Fever (Mild)
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); Fever (Mild)
Frequency: 4 affected / 55 at risk

Adverse event: Fever (Potentially life threatening)
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); Fever (Potentially life threatening)
Frequency: 1 affected / 55 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); Fatigue
Frequency: 43 affected / 76 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); Headache
Frequency: 40 affected / 76 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); Chills
Frequency: 11 affected / 61 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); Rash
Frequency: 5 affected / 60 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); Vomiting
Frequency: 4 affected / 56 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); Decreased appetite
Frequency: 8 affected / 61 at risk

Adverse event: New generalized muscle pain
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); New generalized muscle pain
Frequency: 40 affected / 84 at risk

Adverse event: Aggravated generalized muscle pain
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); Aggravated generalized muscle pain
Frequency: 18 affected / 68 at risk

Adverse event: New generalized joint pain
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); New generalized joint pain
Frequency: 9 affected / 62 at risk

Adverse event: Aggravated generalized joint pain
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); Aggravated generalized joint pain
Frequency: 10 affected / 62 at risk

Adverse event: Fever (Any)
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Fever (Any)
Frequency: 12 affected / 263 at risk

Adverse event: Fever (Mild)
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Fever (Mild)
Frequency: 10 affected / 263 at risk

Adverse event: Fever (Moderate)
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Fever (Moderate)
Frequency: 2 affected / 259 at risk

Adverse event: Fever (Severe)
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Fever (Severe)
Frequency: 1 affected / 259 at risk

Adverse event: Fever (Potentially life threatening)
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Fever (Potentially life threatening)
Frequency: 1 affected / 258 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Fatigue
Frequency: 162 affected / 321 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Headache
Frequency: 163 affected / 328 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Chills
Frequency: 57 affected / 286 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Rash
Frequency: 23 affected / 267 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Vomiting
Frequency: 8 affected / 261 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Decreased appetite
Frequency: 41 affected / 278 at risk

Adverse event: New generalized muscle pain
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); New generalized muscle pain
Frequency: 152 affected / 324 at risk

Adverse event: Aggravated generalized muscle pain
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Aggravated generalized muscle pain
Frequency: 63 affected / 286 at risk

Adverse event: New generalized joint pain
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); New generalized joint pain
Frequency: 43 affected / 278 at risk

Adverse event: Aggravated generalized joint pain
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Aggravated generalized joint pain
Frequency: 38 affected / 272 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 237 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 237 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 237 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 237 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 237 at risk

Adverse event: Coronary artery disease
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 237 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 237 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 237 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 237 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 237 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 237 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 237 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 237 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 237 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 237 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 237 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 237 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 237 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 237 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 237 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 237 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 237 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 237 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 237 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 237 at risk

Adverse event: Onychomycosis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 237 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 237 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 237 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 237 at risk

Adverse event: Tooth abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 237 at risk

Adverse event: Foot fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 237 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 237 at risk

Adverse event: Hypomagnesaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 237 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 237 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 237 at risk

Adverse event: Osteopenia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 237 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 237 at risk

Adverse event: Intervertebral disc protrusion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 237 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 237 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 237 at risk

Adverse event: Tension headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 237 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 237 at risk

Adverse event: Hypertonic bladder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 237 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 237 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 237 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 237 at risk

Adverse event: Respiratory disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 237 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 237 at risk

Adverse event: Sleep apnoea syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 237 at risk

Adverse event: Upper respiratory tract congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 237 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 237 at risk

Adverse event: Lichen planus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 237 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 237 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS Year 0; Redness (Any) redness present
Frequency: 15 affected / 134 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS Year 0; Redness (Mild) 2.5 to 5.0 cm
Frequency: 13 affected / 134 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS Year 0; Redness (Moderate) 5.1 to 10.0 cm
Frequency: 5 affected / 128 at risk

Adverse event: Redness (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS Year 0; Redness (Severe) \>10 cm
Frequency: 1 affected / 127 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS Year 0; Swelling (Any) swelling present
Frequency: 14 affected / 135 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS Year 0; Swelling (Mild) 2.5 to 5.0 cm
Frequency: 8 affected / 132 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS Year 0; Swelling (Moderate) 5.1 to 10.0 cm
Frequency: 10 affected / 132 at risk

Adverse event: Pain (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS Year 0; Pain (Any) pain present
Frequency: 102 affected / 175 at risk

Adverse event: Pain (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS Year 0; Pain (Mild) awareness of pain; easily tolerated
Frequency: 90 affected / 170 at risk

Adverse event: Pain (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS Year 0; Pain (Moderate) discomfort enough to cause interference with usual activity
Frequency: 31 affected / 143 at risk

Adverse event: Pain (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS Year 0; Pain (Severe) incapacitating
Frequency: 1 affected / 127 at risk

Adverse event: Limitation of arm movement (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS Year 0; Limitation of arm movement (Any) limitation present
Frequency: 40 affected / 142 at risk

Adverse event: Limitation of arm movement (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS Year 0; Limitation of arm movement (Mild) some limitation
Frequency: 37 affected / 142 at risk

Adverse event: Limitation of arm movement (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS Year 0; Limitation of arm movement (Moderate) unable to move arm above head; able to move arm above shoulder
Frequency: 4 affected / 127 at risk

Adverse event: Limitation of arm movement (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC and 23vPS Year 0; Limitation of arm movement (Severe) unable to move arm above shoulder
Frequency: 3 affected / 128 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Redness (Any)
Frequency: 15 affected / 134 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Redness (Mild)
Frequency: 13 affected / 134 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Redness (Moderate)
Frequency: 5 affected / 128 at risk

Adverse event: Redness (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Redness (Severe)
Frequency: 1 affected / 127 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Swelling (Any)
Frequency: 14 affected / 135 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Swelling (Mild)
Frequency: 8 affected / 132 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Swelling (Moderate)
Frequency: 10 affected / 132 at risk

Adverse event: Pain (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Pain (Any)
Frequency: 102 affected / 175 at risk

Adverse event: Pain (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Pain (Mild)
Frequency: 90 affected / 170 at risk

Adverse event: Pain (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Pain (Moderate)
Frequency: 31 affected / 143 at risk

Adverse event: Pain (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Pain (Severe)
Frequency: 1 affected / 127 at risk

Adverse event: Limitation of arm movement (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Limitation of arm movement (Any)
Frequency: 40 affected / 142 at risk

Adverse event: Limitation of arm movement (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Limitation of arm movement (Mild)
Frequency: 37 affected / 142 at risk

Adverse event: Limitation of arm movement (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Limitation of arm movement (Moderate)
Frequency: 4 affected / 127 at risk

Adverse event: Limitation of arm movement (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Limitation of arm movement (Severe)
Frequency: 3 affected / 128 at risk

Adverse event: Fever (Any)
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS Year 0; Fever (Any) ≥38 degrees C
Frequency: 2 affected / 127 at risk

Adverse event: Fever (Mild)
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS Year 0; Fever (Mild) ≥38 but \<38.5 degrees C
Frequency: 1 affected / 127 at risk

Adverse event: Fever (Severe)
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS Year 0; Fever (Severe) ≥39 but ≤40 degrees C
Frequency: 1 affected / 127 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS Year 0; Fatigue
Frequency: 85 affected / 173 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS Year 0; Headache
Frequency: 77 affected / 167 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS Year 0; Chills
Frequency: 39 affected / 145 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS Year 0; Rash
Frequency: 18 affected / 134 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS Year 0; Vomiting
Frequency: 4 affected / 131 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS Year 0; Decreased appetite
Frequency: 34 affected / 148 at risk

Adverse event: New generalized muscle pain
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS Year 0; New generalized muscle pain
Frequency: 86 affected / 167 at risk

Adverse event: Aggravated generalized muscle pain
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS Year 0; Aggravated generalized muscle pain
Frequency: 50 affected / 154 at risk

Adverse event: New generalized joint pain
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS Year 0; New generalized joint pain
Frequency: 35 affected / 147 at risk

Adverse event: Aggravated generalized joint pain
Serious: no
Organ System: General disorders
Notes: 13vPnC and 23vPS Year 0; Aggravated generalized joint pain
Frequency: 30 affected / 142 at risk

Adverse event: Fever (Any)
Serious: no
Organ System: General disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Fever (Any)
Frequency: 2 affected / 127 at risk

Adverse event: Fever (Mild)
Serious: no
Organ System: General disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Fever (Mild)
Frequency: 1 affected / 127 at risk

Adverse event: Fever (Severe)
Serious: no
Organ System: General disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Fever (Severe)
Frequency: 1 affected / 127 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Fatigue
Frequency: 85 affected / 173 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Headache
Frequency: 77 affected / 167 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Chills
Frequency: 39 affected / 145 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Rash
Frequency: 18 affected / 134 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Vomiting
Frequency: 4 affected / 131 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Decreased appetite
Frequency: 34 affected / 148 at risk

Adverse event: New generalized muscle pain
Serious: no
Organ System: General disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); New generalized muscle pain
Frequency: 86 affected / 167 at risk

Adverse event: Aggravated generalized muscle pain
Serious: no
Organ System: General disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Aggravated generalized muscle pain
Frequency: 50 affected / 154 at risk

Adverse event: New generalized joint pain
Serious: no
Organ System: General disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); New generalized joint pain
Frequency: 35 affected / 147 at risk

Adverse event: Aggravated generalized joint pain
Serious: no
Organ System: General disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Aggravated generalized joint pain
Frequency: 30 affected / 142 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 478 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 478 at risk

Adverse event: Vertigo positional
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 478 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 478 at risk

Adverse event: Intestinal infarction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 478 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 478 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 478 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 478 at risk

Adverse event: Cellulitis orbital
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 478 at risk

Adverse event: Perirectal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 478 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 478 at risk

Adverse event: Post procedural bile leak
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 478 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 478 at risk

Adverse event: Squamous cell carcinoma of skin
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 478 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 478 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 478 at risk

Adverse event: Gastrointestinal stromal tumour
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 478 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 478 at risk

Adverse event: Endometriosis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 478 at risk

Adverse event: Ovarian adhesion
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 478 at risk

Adverse event: Uterine polyp
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 478 at risk

Adverse event: Haemothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 478 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 478 at risk

Adverse event: Coronary artery disease
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 478 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 478 at risk

Adverse event: Aortic valve incompetence
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 478 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 478 at risk

Adverse event: Diverticulum
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 478 at risk

Adverse event: Anal fissure
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 478 at risk

Adverse event: Ileus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 478 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 478 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 478 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 478 at risk

Adverse event: Onychomycosis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 478 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 478 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 478 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 478 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 478 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 478 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 478 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 478 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 478 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 478 at risk

Adverse event: Gout
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 478 at risk

Adverse event: Periarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 478 at risk

Adverse event: Rotator cuff syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 478 at risk

Adverse event: Bladder cancer
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 478 at risk

Adverse event: Lipoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 478 at risk

Adverse event: Lung neoplasm
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 478 at risk

Adverse event: Restless legs syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 478 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 478 at risk

Adverse event: Sleep disorder due to a general medical condition
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 478 at risk

Adverse event: Hypertonic bladder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 478 at risk

Adverse event: Cervical dysplasia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 478 at risk

Adverse event: Sexual dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 478 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 478 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 478 at risk

Adverse event: Acute respiratory distress syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 478 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 478 at risk

Adverse event: Dyspnoea exertional
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 478 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 478 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 478 at risk

Adverse event: Orthostatic hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 478 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 237 at risk

Adverse event: Staphylococcal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 237 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 237 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 237 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 237 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 237 at risk

Adverse event: Cardiomegaly
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 237 at risk

Adverse event: Ear pruritus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 237 at risk

Adverse event: Glaucoma
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 237 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 237 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 1 affected / 237 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 237 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 237 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 237 at risk

Adverse event: Blood testosterone decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 237 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 237 at risk

Adverse event: Gout
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 237 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 237 at risk

Adverse event: Type 2 diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 237 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 237 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 237 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 237 at risk

Adverse event: Intervertebral disc protrusion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 237 at risk

Adverse event: Exostosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 237 at risk

Adverse event: Carpal tunnel syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 237 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 237 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 237 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 237 at risk

Adverse event: Urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 237 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 237 at risk

Adverse event: Upper respiratory tract congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 237 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 237 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 237 at risk

Adverse event: Cutaneous lupus erythematosus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 237 at risk

Adverse event: Rosacea
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 237 at risk

Adverse event: Xanthoma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 237 at risk

Adverse event: Postmenopause
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 237 at risk

Adverse event: Peripheral venous disease
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 237 at risk

Adverse event: Gastrointestinal malformation
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 160 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 160 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 160 at risk

Adverse event: Malabsorption
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 160 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 160 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 160 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 160 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 160 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 160 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 160 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 160 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 160 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 160 at risk

Adverse event: Type 2 diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 160 at risk

Adverse event: Vitamin B12 deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 160 at risk

Adverse event: Vitamin D deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 160 at risk

Adverse event: Restless legs syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 160 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 160 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 160 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 160 at risk

Adverse event: Sleep apnoea syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 160 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 160 at risk

Adverse event: Nasal cyst
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 160 at risk

Adverse event: Dermal cyst
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 160 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 160 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); Redness (Any)
Frequency: 7 affected / 61 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); Redness (Mild)
Frequency: 5 affected / 57 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); Redness (Moderate)
Frequency: 2 affected / 58 at risk

Adverse event: Redness (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); Redness (Severe)
Frequency: 2 affected / 57 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); Swelling (Any)
Frequency: 7 affected / 60 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); Swelling (Mild)
Frequency: 5 affected / 59 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); Swelling (Moderate)
Frequency: 2 affected / 55 at risk

Adverse event: Swelling (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); Swelling (Severe)
Frequency: 1 affected / 56 at risk

Adverse event: Pain (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); Pain (Any)
Frequency: 82 affected / 108 at risk

Adverse event: Pain (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); Pain (Mild)
Frequency: 73 affected / 101 at risk

Adverse event: Pain (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); Pain (Moderate)
Frequency: 16 affected / 61 at risk

Adverse event: Pain (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); Pain (Severe)
Frequency: 2 affected / 57 at risk

Adverse event: Limitation of arm movement (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); Limitation of arm movement (Any)
Frequency: 16 affected / 65 at risk

Adverse event: Limitation of arm movement (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); Limitation of arm movement (Mild)
Frequency: 16 affected / 65 at risk

Adverse event: Limitation of arm movement (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); Limitation of arm movement (Severe)
Frequency: 1 affected / 56 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Redness (Any)
Frequency: 11 affected / 86 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Redness (Mild)
Frequency: 6 affected / 83 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Redness (Moderate)
Frequency: 6 affected / 83 at risk

Adverse event: Redness (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Redness (Severe)
Frequency: 2 affected / 83 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Swelling (Any)
Frequency: 12 affected / 86 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Swelling (Mild)
Frequency: 9 affected / 85 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Swelling (Moderate)
Frequency: 5 affected / 82 at risk

Adverse event: Swelling (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Swelling (Severe)
Frequency: 1 affected / 82 at risk

Adverse event: Pain (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Pain (Any)
Frequency: 97 affected / 129 at risk

Adverse event: Pain (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Pain (Mild)
Frequency: 89 affected / 123 at risk

Adverse event: Pain (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Pain (Moderate)
Frequency: 22 affected / 91 at risk

Adverse event: Pain (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Pain (Severe)
Frequency: 2 affected / 83 at risk

Adverse event: Limitation of arm movement (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Limitation of arm movement (Any)
Frequency: 26 affected / 93 at risk

Adverse event: Limitation of arm movement (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Limitation of arm movement (Mild)
Frequency: 25 affected / 92 at risk

Adverse event: Limitation of arm movement (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Limitation of arm movement (Moderate)
Frequency: 3 affected / 83 at risk

Adverse event: Limitation of arm movement (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Limitation of arm movement (Severe)
Frequency: 1 affected / 82 at risk

Adverse event: Fever (Any)
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); Fever (Any)
Frequency: 2 affected / 55 at risk

Adverse event: Fever (Moderate)
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); Fever (Moderate)
Frequency: 1 affected / 55 at risk

Adverse event: Fever (Potentially life threatening)
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); Fever (Potentially life threatening)
Frequency: 1 affected / 55 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); Fatigue
Frequency: 33 affected / 76 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); Headache
Frequency: 34 affected / 76 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); Chills
Frequency: 12 affected / 61 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); Rash
Frequency: 6 affected / 60 at risk

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

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); Decreased appetite
Frequency: 13 affected / 61 at risk

Adverse event: New generalized muscle pain
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); New generalized muscle pain
Frequency: 43 affected / 84 at risk

Adverse event: Aggravated generalized muscle pain
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); Aggravated generalized muscle pain
Frequency: 21 affected / 68 at risk

Adverse event: New generalized joint pain
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); New generalized joint pain
Frequency: 10 affected / 62 at risk

Adverse event: Aggravated generalized joint pain
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 13vPnC / 13vPnC (Year 1); Aggravated generalized joint pain
Frequency: 12 affected / 62 at risk

Adverse event: Fever (Any)
Serious: no
Organ System: General disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Fever (Any)
Frequency: 2 affected / 81 at risk

Adverse event: Fever (Moderate)
Serious: no
Organ System: General disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Fever (Moderate)
Frequency: 1 affected / 81 at risk

Adverse event: Fever (Potentially life threatening)
Serious: no
Organ System: General disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Fever (Potentially life threatening)
Frequency: 1 affected / 81 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Fatigue
Frequency: 39 affected / 100 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Headache
Frequency: 40 affected / 96 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Chills
Frequency: 17 affected / 90 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Rash
Frequency: 9 affected / 86 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Vomiting
Frequency: 3 affected / 82 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Decreased appetite
Frequency: 16 affected / 89 at risk

Adverse event: New generalized muscle pain
Serious: no
Organ System: General disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); New generalized muscle pain
Frequency: 54 affected / 108 at risk

Adverse event: Aggravated generalized muscle pain
Serious: no
Organ System: General disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Aggravated generalized muscle pain
Frequency: 25 affected / 94 at risk

Adverse event: New generalized joint pain
Serious: no
Organ System: General disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); New generalized joint pain
Frequency: 13 affected / 87 at risk

Adverse event: Aggravated generalized joint pain
Serious: no
Organ System: General disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Aggravated generalized joint pain
Frequency: 16 affected / 91 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 267 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 267 at risk

Adverse event: Coronary artery stenosis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 267 at risk

Adverse event: Eyelid irritation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 267 at risk

Adverse event: Maculopathy
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 267 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 267 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 267 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 267 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 267 at risk

Adverse event: Cyst
Serious: no
Organ System: General disorders
Frequency: 1 affected / 267 at risk

Adverse event: Injection site rash
Serious: no
Organ System: General disorders
Frequency: 1 affected / 267 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 267 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 267 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 267 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 267 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 267 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 267 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 267 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 267 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 267 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 267 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 267 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 267 at risk

Adverse event: Upper limb fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 267 at risk

Adverse event: Gout
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 267 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 267 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 267 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 267 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 267 at risk

Adverse event: Arthropathy
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 267 at risk

Adverse event: Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 267 at risk

Adverse event: Joint range of motion decreased
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 267 at risk

Adverse event: Joint swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 267 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 267 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 267 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 267 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 267 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 267 at risk

Adverse event: Hypertonic bladder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 267 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 267 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 267 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 267 at risk

Adverse event: Pulmonary congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 267 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 267 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 267 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 267 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 267 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 267 at risk

Adverse event: Venous valve ruptured
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 267 at risk

Adverse event: Diverticulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 267 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Redness (Any)
Frequency: 42 affected / 151 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Redness (Mild)
Frequency: 28 affected / 144 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Redness (Moderate)
Frequency: 17 affected / 138 at risk

Adverse event: Redness (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Redness (Severe)
Frequency: 9 affected / 131 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Swelling (Any)
Frequency: 40 affected / 155 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Swelling (Mild)
Frequency: 30 affected / 149 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Swelling (Moderate)
Frequency: 17 affected / 138 at risk

Adverse event: Swelling (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Swelling (Severe)
Frequency: 8 affected / 132 at risk

Adverse event: Pain (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Pain (Any)
Frequency: 198 affected / 231 at risk

Adverse event: Pain (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Pain (Mild)
Frequency: 161 affected / 205 at risk

Adverse event: Pain (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Pain (Moderate)
Frequency: 87 affected / 176 at risk

Adverse event: Pain (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Pain (Severe)
Frequency: 18 affected / 140 at risk

Adverse event: Limitation of arm movement (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Limitation of arm movement (Any)
Frequency: 95 affected / 178 at risk

Adverse event: Limitation of arm movement (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Limitation of arm movement (Mild)
Frequency: 81 affected / 171 at risk

Adverse event: Limitation of arm movement (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Limitation of arm movement (Moderate)
Frequency: 14 affected / 134 at risk

Adverse event: Limitation of arm movement (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Limitation of arm movement (Severe)
Frequency: 11 affected / 135 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Redness (Any)
Frequency: 42 affected / 151 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Redness (Mild)
Frequency: 28 affected / 144 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Redness (Moderate)
Frequency: 17 affected / 138 at risk

Adverse event: Redness (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Redness (Severe)
Frequency: 9 affected / 131 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Swelling (Any)
Frequency: 40 affected / 155 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Swelling (Mild)
Frequency: 30 affected / 149 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Swelling (Moderate)
Frequency: 17 affected / 138 at risk

Adverse event: Swelling (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Swelling (Severe)
Frequency: 8 affected / 132 at risk

Adverse event: Pain (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Pain (Any)
Frequency: 198 affected / 231 at risk

Adverse event: Pain (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Pain (Mild)
Frequency: 161 affected / 205 at risk

Adverse event: Pain (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Pain (Moderate)
Frequency: 87 affected / 176 at risk

Adverse event: Pain (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Pain (Severe)
Frequency: 18 affected / 140 at risk

Adverse event: Limitation of arm movement (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Limitation of arm movement (Any)
Frequency: 95 affected / 178 at risk

Adverse event: Limitation of arm movement (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Limitation of arm movement (Mild)
Frequency: 81 affected / 171 at risk

Adverse event: Limitation of arm movement (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Limitation of arm movement (Moderate)
Frequency: 14 affected / 134 at risk

Adverse event: Limitation of arm movement (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Limitation of arm movement (Severe)
Frequency: 11 affected / 135 at risk

Adverse event: Fever (Any)
Serious: no
Organ System: General disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Fever (Any)
Frequency: 4 affected / 129 at risk

Adverse event: Fever (Mild)
Serious: no
Organ System: General disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Fever (Mild)
Frequency: 4 affected / 129 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Fatigue
Frequency: 96 affected / 185 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Headache
Frequency: 87 affected / 175 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Chills
Frequency: 45 affected / 155 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Rash
Frequency: 35 affected / 146 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Vomiting
Frequency: 6 affected / 131 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Decreased appetite
Frequency: 24 affected / 141 at risk

Adverse event: New generalized muscle pain
Serious: no
Organ System: General disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); New generalized muscle pain
Frequency: 120 affected / 196 at risk

Adverse event: Aggravated generalized muscle pain
Serious: no
Organ System: General disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Aggravated generalized muscle pain
Frequency: 68 affected / 164 at risk

Adverse event: New generalized joint pain
Serious: no
Organ System: General disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); New generalized joint pain
Frequency: 39 affected / 153 at risk

Adverse event: Aggravated generalized joint pain
Serious: no
Organ System: General disorders
Notes: 23vPS (Year 0) and 13vPnC / 23vPS (Year 1); Aggravated generalized joint pain
Frequency: 25 affected / 143 at risk

Adverse event: Fever (Any)
Serious: no
Organ System: General disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Fever (Any)
Frequency: 4 affected / 129 at risk

Adverse event: Fever (Mild)
Serious: no
Organ System: General disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Fever (Mild)
Frequency: 4 affected / 129 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Fatigue
Frequency: 96 affected / 185 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Headache
Frequency: 87 affected / 175 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Chills
Frequency: 45 affected / 155 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Rash
Frequency: 35 affected / 146 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Vomiting
Frequency: 6 affected / 131 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Decreased appetite
Frequency: 24 affected / 141 at risk

Adverse event: New generalized muscle pain
Serious: no
Organ System: General disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); New generalized muscle pain
Frequency: 120 affected / 196 at risk

Adverse event: Aggravated generalized muscle pain
Serious: no
Organ System: General disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Aggravated generalized muscle pain
Frequency: 68 affected / 164 at risk

Adverse event: New generalized joint pain
Serious: no
Organ System: General disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); New generalized joint pain
Frequency: 39 affected / 153 at risk

Adverse event: Aggravated generalized joint pain
Serious: no
Organ System: General disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Aggravated generalized joint pain
Frequency: 25 affected / 143 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 223 at risk

Adverse event: Type V hyperlipidaemia
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 223 at risk

Adverse event: Testicular failure
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 223 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 223 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 223 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 2 affected / 223 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 223 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 223 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 223 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 223 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 223 at risk

Adverse event: Tooth abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 223 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 223 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 223 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 223 at risk

Adverse event: Avulsion fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 223 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 223 at risk

Adverse event: Meniscus injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 223 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 223 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 223 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 223 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 223 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 223 at risk

Adverse event: Intervertebral disc protrusion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 223 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 223 at risk

Adverse event: Seborrhoeic keratosis
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 223 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 223 at risk

Adverse event: Hallucination
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 223 at risk

Adverse event: Sleep disorder due to general medical condition, insomnia type
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 223 at risk

Adverse event: Benign prostatic hyperplasia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 223 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 223 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 223 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 223 at risk

Adverse event: Pulmonary congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 223 at risk

Adverse event: Precancerous skin lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 223 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 223 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Redness (Any)
Frequency: 5 affected / 115 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Redness (Mild)
Frequency: 5 affected / 115 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Redness (Moderate)
Frequency: 1 affected / 115 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Swelling (Any)
Frequency: 6 affected / 119 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Swelling (Mild)
Frequency: 6 affected / 119 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Swelling (Moderate)
Frequency: 1 affected / 116 at risk

Adverse event: Pain (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Pain (Any)
Frequency: 118 affected / 169 at risk

Adverse event: Pain (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Pain (Mild)
Frequency: 113 affected / 166 at risk

Adverse event: Pain (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Pain (Moderate)
Frequency: 23 affected / 129 at risk

Adverse event: Pain (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Pain (Severe)
Frequency: 1 affected / 116 at risk

Adverse event: Limitation of arm movement (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Limitation of arm movement (Any)
Frequency: 24 affected / 130 at risk

Adverse event: Limitation of arm movement (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Limitation of arm movement (Mild)
Frequency: 22 affected / 130 at risk

Adverse event: Limitation of arm movement (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Limitation of arm movement (Severe)
Frequency: 2 affected / 115 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Redness (Any)
Frequency: 5 affected / 115 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Redness (Mild)
Frequency: 5 affected / 115 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Redness (Moderate)
Frequency: 1 affected / 115 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Swelling (Any)
Frequency: 6 affected / 119 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Swelling (Mild)
Frequency: 6 affected / 119 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Swelling (Moderate)
Frequency: 1 affected / 116 at risk

Adverse event: Pain (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Pain (Any)
Frequency: 118 affected / 169 at risk

Adverse event: Pain (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Pain (Mild)
Frequency: 113 affected / 166 at risk

Adverse event: Pain (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Pain (Moderate)
Frequency: 23 affected / 129 at risk

Adverse event: Pain (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Pain (Severe)
Frequency: 1 affected / 116 at risk

Adverse event: Limitation of arm movement (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Limitation of arm movement (Any)
Frequency: 24 affected / 130 at risk

Adverse event: Limitation of arm movement (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Limitation of arm movement (Mild)
Frequency: 22 affected / 130 at risk

Adverse event: Limitation of arm movement (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Limitation of arm movement (Severe)
Frequency: 2 affected / 115 at risk

Adverse event: Fever (Any)
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Fever (Any)
Frequency: 1 affected / 116 at risk

Adverse event: Fever (Mild)
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Fever (Mild)
Frequency: 1 affected / 116 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Fatigue
Frequency: 58 affected / 141 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Headache
Frequency: 56 affected / 139 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Chills
Frequency: 25 affected / 127 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Rash
Frequency: 10 affected / 121 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Vomiting
Frequency: 8 affected / 118 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Decreased appetite
Frequency: 16 affected / 123 at risk

Adverse event: New generalized muscle pain
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); New generalized muscle pain
Frequency: 68 affected / 151 at risk

Adverse event: Aggravated generalized muscle pain
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Aggravated generalized muscle pain
Frequency: 39 affected / 136 at risk

Adverse event: New generalized joint pain
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); New generalized joint pain
Frequency: 25 affected / 128 at risk

Adverse event: Aggravated generalized joint pain
Serious: no
Organ System: General disorders
Notes: 13vPnC (Year 0) and 23vPS / 13vPnC (Year 1); Aggravated generalized joint pain
Frequency: 28 affected / 131 at risk

Adverse event: Fever (Any)
Serious: no
Organ System: General disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Fever (Any)
Frequency: 1 affected / 116 at risk

Adverse event: Fever (Mild)
Serious: no
Organ System: General disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Fever (Mild)
Frequency: 1 affected / 116 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Fatigue
Frequency: 58 affected / 141 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Headache
Frequency: 56 affected / 139 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Chills
Frequency: 25 affected / 127 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Rash
Frequency: 10 affected / 121 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Vomiting
Frequency: 8 affected / 118 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Decreased appetite
Frequency: 16 affected / 123 at risk

Adverse event: New generalized muscle pain
Serious: no
Organ System: General disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); New generalized muscle pain
Frequency: 68 affected / 151 at risk

Adverse event: Aggravated generalized muscle pain
Serious: no
Organ System: General disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Aggravated generalized muscle pain
Frequency: 39 affected / 136 at risk

Adverse event: New generalized joint pain
Serious: no
Organ System: General disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); New generalized joint pain
Frequency: 25 affected / 128 at risk

Adverse event: Aggravated generalized joint pain
Serious: no
Organ System: General disorders
Notes: 13vPnC / 13vPnC (Year 1), 13vPnC / 23vPS (Year 1), and 23vPS / 13vPnC (Year 1); Aggravated generalized joint pain
Frequency: 28 affected / 131 at risk

Adverse event: Foot fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 160 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 160 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 160 at risk

Adverse event: Uterine cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 160 at risk

Adverse event: Atrioventricular block first degree
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 160 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 160 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 160 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 160 at risk

Adverse event: Diverticulum intestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 160 at risk

Adverse event: Crohn's disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 160 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 160 at risk

Adverse event: Cyst
Serious: no
Organ System: General disorders
Frequency: 1 affected / 160 at risk

Adverse event: Cholelithiasis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 160 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 160 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 160 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 160 at risk

Adverse event: Lung neoplasm
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 160 at risk

Adverse event: Benign breast neoplasm
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 160 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 160 at risk

Adverse event: Hypertonic bladder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 160 at risk

Adverse event: Chronic kidney disease
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 160 at risk

Adverse event: Atrophic vulvovaginitis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 160 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 160 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 160 at risk

Adverse event: Obstructive airways disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 160 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 267 at risk

Adverse event: Goitre
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 267 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 267 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 267 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 267 at risk

Adverse event: Intervertebral disc degeneration
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 267 at risk

Adverse event: Lumbar spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 267 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 267 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 267 at risk

Adverse event: Polycythaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 267 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 267 at risk

Adverse event: Vertigo positional
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 267 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 267 at risk

Adverse event: Diverticulum
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 267 at risk

Adverse event: Diverticulum intestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 267 at risk

Adverse event: Ascites
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 267 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 267 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 267 at risk

Adverse event: Dyslipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 267 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 267 at risk

Adverse event: Osteopenia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 267 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 267 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 267 at risk

Adverse event: Tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 267 at risk

Adverse event: Spinal osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 267 at risk

Adverse event: Nodal osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 267 at risk

Adverse event: Carpal tunnel syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 267 at risk

Adverse event: Diabetic neuropathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 267 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 267 at risk

Adverse event: Atrophic vulvovaginitis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 267 at risk

Adverse event: Prostatitis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 267 at risk

Adverse event: Sleep apnoea syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 267 at risk

Adverse event: Eczema nummular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 267 at risk

Adverse event: Nail discolouration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 267 at risk

Adverse event: Psoriasis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 267 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 267 at risk

Adverse event: Arteriosclerosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 267 at risk

Adverse event: Peripheral vascular disorder
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 267 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 223 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 223 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 223 at risk

Adverse event: Accidental overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 223 at risk

Adverse event: Benign neoplasm of skin
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 223 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 223 at risk

Adverse event: Androgen deficiency
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 223 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 223 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 223 at risk

Adverse event: Cholelithiasis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 223 at risk

Adverse event: Infectious mononucleosis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 223 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 223 at risk

Adverse event: Meniscus injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 223 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 223 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 223 at risk

Adverse event: Type 2 diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 223 at risk

Adverse event: Vitamin D deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 223 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 223 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 223 at risk

Adverse event: Tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 223 at risk

Adverse event: Enthesopathy
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 223 at risk

Adverse event: Intervertebral disc degeneration
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 223 at risk

Adverse event: Patellofemoral pain syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 223 at risk

Adverse event: Tenosynovitis stenosans
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 223 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 223 at risk

Adverse event: Restless legs syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 223 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 223 at risk

Adverse event: Lumbar radiculopathy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 223 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 223 at risk

Adverse event: Benign prostatic hyperplasia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 223 at risk

Adverse event: Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 223 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 223 at risk

Adverse event: Sleep apnoea syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 223 at risk

Adverse event: Diverticulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 223 at risk