Study: NCT02993757

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 263 at risk

Adverse event: Chikungunya virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 263 at risk

Adverse event: Dengue fever
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 263 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 263 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 263 at risk

Adverse event: Pneumonia mycoplasmal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 263 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 263 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 263 at risk

Adverse event: Tendon rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 263 at risk

Adverse event: Glomerulonephritis acute
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 263 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 263 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 133 affected / 263 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 45 affected / 263 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 206 affected / 263 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 43 affected / 263 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 111 affected / 263 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Pyrexia events that occurred after 14 days post-vaccination were considered as unsolicited AE.
Frequency: 39 affected / 263 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 263 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 127 affected / 263 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headache events that occurred after 14 days post-vaccination were considered as unsolicited AE.
Frequency: 126 affected / 263 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 260 at risk

Adverse event: Dengue fever
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 260 at risk

Adverse event: Gingival abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 260 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 260 at risk

Adverse event: Sports injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 260 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 260 at risk

Adverse event: Tonsillar hypertrophy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 260 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 132 affected / 260 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 38 affected / 260 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 193 affected / 260 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 31 affected / 260 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 137 affected / 260 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Pyrexia events that occurred after 14 days post-vaccination were considered as unsolicited AE.
Frequency: 53 affected / 260 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 30 affected / 260 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 156 affected / 260 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headache events that occurred after 14 days post-vaccination were considered as unsolicited AE.
Frequency: 147 affected / 260 at risk