Study: NCT02628444

Adverse event: Branchial cyst
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 348 at risk

Adverse event: Thyroid cyst
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 348 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 348 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 348 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 348 at risk

Adverse event: Gun shot wound
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 348 at risk

Adverse event: Jaw fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 348 at risk

Adverse event: Pathological fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 348 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 348 at risk

Adverse event: Threatened labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 348 at risk

Adverse event: Calculus urinary
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 348 at risk

Adverse event: Renal colic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 348 at risk

Adverse event: Uterine polyp
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 348 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 348 at risk

Adverse event: Toxic skin eruption
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 348 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 98 affected / 348 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 29 affected / 348 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 109 affected / 348 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Events of malaise that occurred after 14 days post-vaccination were considered as unsolicited AE.
Frequency: 114 affected / 348 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Events of myalgia that occurred after 14 days post-vaccination were considered as unsolicited AE.
Frequency: 110 affected / 348 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Events of headache that occurred after 14 days post-vaccination were considered as unsolicited AE.
Frequency: 129 affected / 348 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 348 at risk

Adverse event: Food poisoning
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 348 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 348 at risk

Adverse event: Groin abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 348 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 348 at risk

Adverse event: Pneumonia staphylococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 348 at risk

Adverse event: Animal bite
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 348 at risk

Adverse event: Forearm fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 348 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 348 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 348 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 348 at risk

Adverse event: Intervertebral disc degeneration
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 348 at risk

Adverse event: Rheumatoid arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 348 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 348 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 348 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 348 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 348 at risk

Adverse event: Abortion spontaneous incomplete
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 348 at risk

Adverse event: Adenomyosis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 348 at risk

Adverse event: Bartholin's cyst
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 348 at risk

Adverse event: Abnormal uterine bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 348 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 348 at risk

Adverse event: Arteriosclerosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 348 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 80 affected / 348 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 21 affected / 348 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 114 affected / 348 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Events of malaise that occurred after 14 days post-vaccination were considered as unsolicited AE.
Frequency: 98 affected / 348 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Events of myalgia that occurred after 14 days post-vaccination were considered as unsolicited AE.
Frequency: 92 affected / 348 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Events of headache that occurred after 14 days post-vaccination were considered as unsolicited AE.
Frequency: 123 affected / 348 at risk

Adverse event: Food allergy
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 352 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 352 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 352 at risk

Adverse event: Diarrhoea infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 352 at risk

Adverse event: Orchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 352 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 352 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 352 at risk

Adverse event: Gun shot wound
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 352 at risk

Adverse event: Radius fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 352 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 352 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 352 at risk

Adverse event: Papillary thyroid cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 352 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 352 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 352 at risk

Adverse event: Abortion spontaneous incomplete
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 352 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 352 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 352 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 71 affected / 352 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 31 affected / 352 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 97 affected / 352 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Events of malaise that occurred after 14 days post-vaccination were considered as unsolicited AE.
Frequency: 103 affected / 352 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Events of myalgia that occurred after 14 days post-vaccination were considered as unsolicited AE.
Frequency: 87 affected / 352 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Events of headache that occurred after 14 days post-vaccination were considered as unsolicited AE.
Frequency: 124 affected / 352 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 55 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 55 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 55 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 55 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 55 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 55 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Events of malaise that occurred after 14 days post-vaccination were considered as unsolicited AE.
Frequency: 5 affected / 55 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Events of myalgia that occurred after 14 days post-vaccination were considered as unsolicited AE.
Frequency: 5 affected / 55 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Events of headache that occurred after 14 days post-vaccination were considered as unsolicited AE.
Frequency: 5 affected / 55 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 53 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 53 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 53 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 7 affected / 53 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Events of malaise that occurred after 14 days post-vaccination were considered as unsolicited AE.
Frequency: 7 affected / 53 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Events of myalgia that occurred after 14 days post-vaccination were considered as unsolicited AE.
Frequency: 9 affected / 53 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Events of headache that occurred after 14 days post-vaccination were considered as unsolicited AE.
Frequency: 7 affected / 53 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 59 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 7 affected / 59 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Events of malaise that occurred after 14 days post-vaccination were considered as unsolicited AE.
Frequency: 9 affected / 59 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Events of myalgia that occurred after 14 days post-vaccination were considered as unsolicited AE.
Frequency: 8 affected / 59 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Events of headache that occurred after 14 days post-vaccination were considered as unsolicited AE.
Frequency: 11 affected / 59 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 56 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 56 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 12 affected / 56 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Events of malaise that occurred after 14 days post-vaccination were considered as unsolicited AE.
Frequency: 9 affected / 56 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Events of myalgia that occurred after 14 days post-vaccination were considered as unsolicited AE.
Frequency: 12 affected / 56 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Events of headache that occurred after 14 days post-vaccination were considered as unsolicited AE.
Frequency: 12 affected / 56 at risk

Adverse event: Hepatitis A
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 62 at risk

Adverse event: Forearm fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 62 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 62 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 62 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 11 affected / 62 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Events of malaise that occurred after 14 days post-vaccination were considered as unsolicited AE.
Frequency: 7 affected / 62 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Events of myalgia that occurred after 14 days post-vaccination were considered as unsolicited AE.
Frequency: 9 affected / 62 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Events of headache that occurred after 14 days post-vaccination were considered as unsolicited AE.
Frequency: 7 affected / 62 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 53 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 10 affected / 53 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Events of malaise that occurred after 14 days post-vaccination were considered as unsolicited AE.
Frequency: 5 affected / 53 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Events of myalgia that occurred after 14 days post-vaccination were considered as unsolicited AE.
Frequency: 6 affected / 53 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Events of headache that occurred after 14 days post-vaccination were considered as unsolicited AE.
Frequency: 7 affected / 53 at risk