Study: NCT01646398

Adverse event: Pancreatic carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 382 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 382 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 382 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 382 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 382 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 382 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 382 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 382 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 382 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 382 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 382 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 382 at risk

Adverse event: Vaccination site pruritus
Serious: no
Organ System: General disorders
Frequency: 1 affected / 382 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 382 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 382 at risk

Adverse event: Foot fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 382 at risk

Adverse event: Rib fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 382 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 382 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 382 at risk

Adverse event: Intervertebral disc protrusion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 382 at risk

Adverse event: Periarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 382 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 382 at risk

Adverse event: Intercostal neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 382 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 382 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 382 at risk

Adverse event: Prurigo
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 382 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 382 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 102 affected / 355 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 78 affected / 352 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 61 affected / 353 at risk

Adverse event: Redness (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 349 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 76 affected / 353 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 58 affected / 351 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 34 affected / 351 at risk

Adverse event: Swelling (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 349 at risk

Adverse event: Pain (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 165 affected / 362 at risk

Adverse event: Pain (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 164 affected / 362 at risk

Adverse event: Pain (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 349 at risk

Adverse event: Limitation of arm movement (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 58 affected / 355 at risk

Adverse event: Limitation of arm movement (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 55 affected / 355 at risk

Adverse event: Limitation of arm movement (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 348 at risk

Adverse event: Limitation of arm movement (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 348 at risk

Adverse event: Fever >=37.5 to <38.5 degrees C
Serious: no
Organ System: General disorders
Frequency: 9 affected / 348 at risk

Adverse event: Fever >=38.5 to <39 degrees C
Serious: no
Organ System: General disorders
Frequency: 1 affected / 348 at risk

Adverse event: Fever >40 degrees C
Serious: no
Organ System: General disorders
Notes: All reports of fever \>=39 degrees C in 13vPnC and 23vPS were confirmed as data entry errors.
Frequency: 3 affected / 348 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 61 affected / 352 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 33 affected / 351 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 10 affected / 348 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Frequency: 31 affected / 350 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 4 affected / 348 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 13 affected / 348 at risk

Adverse event: New muscle pain
Serious: no
Organ System: General disorders
Frequency: 65 affected / 354 at risk

Adverse event: Aggravated muscle pain
Serious: no
Organ System: General disorders
Frequency: 14 affected / 350 at risk

Adverse event: New joint pain
Serious: no
Organ System: General disorders
Frequency: 27 affected / 350 at risk

Adverse event: Aggravated joint pain
Serious: no
Organ System: General disorders
Frequency: 10 affected / 349 at risk

Adverse event: Meniere's disease
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 382 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 382 at risk

Adverse event: Periodontal disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 382 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 382 at risk

Adverse event: Feeling hot
Serious: no
Organ System: General disorders
Frequency: 1 affected / 382 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 382 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 382 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 382 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 382 at risk

Adverse event: Conjunctivitis bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 382 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 382 at risk

Adverse event: Paronychia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 382 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 382 at risk

Adverse event: Lip injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 382 at risk

Adverse event: Tooth fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 382 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 382 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 382 at risk

Adverse event: Spinal stenosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 382 at risk

Adverse event: Upper respiratory tract inflammation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 382 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 382 at risk

Adverse event: Haemorrhage subcutaneous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 382 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 382 at risk

Adverse event: Redness (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 38 affected / 363 at risk

Adverse event: Redness (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 28 affected / 362 at risk

Adverse event: Redness (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 360 at risk

Adverse event: Redness (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 359 at risk

Adverse event: Swelling (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 24 affected / 360 at risk

Adverse event: Swelling (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 18 affected / 360 at risk

Adverse event: Swelling (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 359 at risk

Adverse event: Swelling (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 359 at risk

Adverse event: Pain (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 141 affected / 368 at risk

Adverse event: Pain (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 138 affected / 368 at risk

Adverse event: Pain (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 20 affected / 361 at risk

Adverse event: Pain (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 359 at risk

Adverse event: Limitation of arm movement (Any)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 61 affected / 362 at risk

Adverse event: Limitation of arm movement (Mild)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 57 affected / 361 at risk

Adverse event: Limitation of arm movement (Moderate)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 360 at risk

Adverse event: Limitation of arm movement (Severe)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 359 at risk

Adverse event: Fever >=37.5 to <38.5 degrees C
Serious: no
Organ System: General disorders
Frequency: 10 affected / 359 at risk

Adverse event: Fever >=38.5 to <39 degrees C
Serious: no
Organ System: General disorders
Frequency: 1 affected / 359 at risk

Adverse event: Fever >=39 to <=40 degrees C
Serious: no
Organ System: General disorders
Notes: All reports of fever \>=39 degrees C in 13vPnC and 23vPS were confirmed as data entry errors.
Frequency: 2 affected / 359 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 58 affected / 362 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 42 affected / 361 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 4 affected / 359 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Frequency: 13 affected / 359 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 2 affected / 359 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: General disorders
Frequency: 18 affected / 360 at risk

Adverse event: New muscle pain
Serious: no
Organ System: General disorders
Frequency: 63 affected / 362 at risk

Adverse event: Aggravated muscle pain
Serious: no
Organ System: General disorders
Frequency: 14 affected / 359 at risk

Adverse event: New joint pain
Serious: no
Organ System: General disorders
Frequency: 25 affected / 359 at risk

Adverse event: Aggravated joint pain
Serious: no
Organ System: General disorders
Frequency: 11 affected / 359 at risk