Study: NCT04138056

Adverse event: Radius fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 101 at risk

Adverse event: Ulna fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 101 at risk

Adverse event: Wrist fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 101 at risk

Adverse event: Injection site pain - Primary Study
Serious: no
Organ System: General disorders
Frequency: 86 affected / 101 at risk

Adverse event: Fatigue - Primary Study
Serious: no
Organ System: General disorders
Frequency: 42 affected / 101 at risk

Adverse event: Injection site erythema - Primary Study
Serious: no
Organ System: General disorders
Frequency: 7 affected / 101 at risk

Adverse event: Injection site swelling - Primary Study
Serious: no
Organ System: General disorders
Frequency: 5 affected / 101 at risk

Adverse event: Pyrexia - Primary Study
Serious: no
Organ System: General disorders
Frequency: 2 affected / 101 at risk

Adverse event: Injection site bruising - Primary Study
Serious: no
Organ System: General disorders
Frequency: 2 affected / 101 at risk

Adverse event: Administration site pain - Primary Study
Serious: no
Organ System: General disorders
Frequency: 2 affected / 101 at risk

Adverse event: Injection site pruritus - Primary Study
Serious: no
Organ System: General disorders
Frequency: 1 affected / 101 at risk

Adverse event: Administration site swelling - Primary Study
Serious: no
Organ System: General disorders
Frequency: 1 affected / 101 at risk

Adverse event: Vaccination site nodule - Primary Study
Serious: no
Organ System: General disorders
Frequency: 1 affected / 101 at risk

Adverse event: Malaise - Primary Study
Serious: no
Organ System: General disorders
Frequency: 1 affected / 101 at risk

Adverse event: Pain - Primary Study
Serious: no
Organ System: General disorders
Frequency: 1 affected / 101 at risk

Adverse event: Axillary pain - Primary Study
Serious: no
Organ System: General disorders
Frequency: 1 affected / 101 at risk

Adverse event: Injection site induration - Primary Study
Serious: no
Organ System: General disorders
Frequency: 1 affected / 101 at risk

Adverse event: Headache - Primary Study
Serious: no
Organ System: Nervous system disorders
Frequency: 47 affected / 101 at risk

Adverse event: Dizziness - Primary Study
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 101 at risk

Adverse event: Disturbance in attention - Primary Study
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 101 at risk

Adverse event: Sciatica - Primary Study
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 101 at risk

Adverse event: Gastrointestinal disorder - Primary Study
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 101 at risk

Adverse event: Nausea - Primary Study
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 101 at risk

Adverse event: Dyspepsia - Primary Study
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 101 at risk

Adverse event: Upper respiratory tract infection - Primary Study
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 101 at risk

Adverse event: Nasopharyngitis - Primary Study
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Urinary tract infection - Primary Study
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Rhinitis - Primary Study
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Pharyngitis - Primary Study
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Tooth infection - Primary Study
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Myalgia - Primary Study
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 101 at risk

Adverse event: Back pain - Primary Study
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 101 at risk

Adverse event: Neck pain - Primary Study
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 101 at risk

Adverse event: Muscle tightness - Primary Study
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 101 at risk

Adverse event: Pain in extremity - Primary Study
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 101 at risk

Adverse event: Musculoskeletal pain - Primary Study
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 101 at risk

Adverse event: Oropharyngeal pain - Primary Study
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 101 at risk

Adverse event: Dermatitis - Primary Study
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 101 at risk

Adverse event: Dermatitis allergic - Primary Study
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 101 at risk

Adverse event: Lymphadenopathy - Primary Study
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 101 at risk

Adverse event: Lymphadenitis - Primary Study
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 101 at risk

Adverse event: Procedural pain - Primary Study
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 101 at risk

Adverse event: Thermal burn - Primary Study
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 101 at risk

Adverse event: Dysmenorrhoea - Primary Study
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 101 at risk

Adverse event: Drug hypersensitivity - Primary Study
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 101 at risk

Adverse event: Injection site pain - Extension Study
Serious: no
Organ System: General disorders
Frequency: 34 affected / 39 at risk

Adverse event: Fatigue - Extension Study
Serious: no
Organ System: General disorders
Frequency: 10 affected / 39 at risk

Adverse event: Injection site erythema - Extension Study
Serious: no
Organ System: General disorders
Frequency: 7 affected / 39 at risk

Adverse event: Injection site swelling - Extension Study
Serious: no
Organ System: General disorders
Frequency: 5 affected / 39 at risk

Adverse event: Malaise - Extension Study
Serious: no
Organ System: General disorders
Frequency: 1 affected / 39 at risk

Adverse event: Administration site pain - Extension Study
Serious: no
Organ System: General disorders
Frequency: 1 affected / 39 at risk

Adverse event: Injection site induration - Extension Study
Serious: no
Organ System: General disorders
Frequency: 1 affected / 39 at risk

Adverse event: Headache - Extension Study
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 39 at risk

Adverse event: Gastrointestinal disorder - Extension Study
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 39 at risk

Adverse event: Abdominal pain - Extension Study
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Diarrhoea - Extension Study
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Vomiting - Extension Study
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Limb discomfort - Extension Study
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 39 at risk

Adverse event: Arthralgia - Extension Study
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 39 at risk

Adverse event: Injection site pain - Primary Study
Serious: no
Organ System: General disorders
Frequency: 62 affected / 101 at risk

Adverse event: Fatigue - Primary Study
Serious: no
Organ System: General disorders
Frequency: 40 affected / 101 at risk

Adverse event: Injection site erythema - Primary Study
Serious: no
Organ System: General disorders
Frequency: 6 affected / 101 at risk

Adverse event: Injection site swelling - Primary Study
Serious: no
Organ System: General disorders
Frequency: 8 affected / 101 at risk

Adverse event: Pyrexia - Primary Study
Serious: no
Organ System: General disorders
Frequency: 4 affected / 101 at risk

Adverse event: Injection site bruising - Primary Study
Serious: no
Organ System: General disorders
Frequency: 2 affected / 101 at risk

Adverse event: Administration site pain - Primary Study
Serious: no
Organ System: General disorders
Frequency: 1 affected / 101 at risk

Adverse event: Administration site erythema - Primary Study
Serious: no
Organ System: General disorders
Frequency: 3 affected / 101 at risk

Adverse event: Injection site pruritus - Primary Study
Serious: no
Organ System: General disorders
Frequency: 2 affected / 101 at risk

Adverse event: Injection site haemorrhage - Primary Study
Serious: no
Organ System: General disorders
Frequency: 2 affected / 101 at risk

Adverse event: Malaise - Primary Study
Serious: no
Organ System: General disorders
Frequency: 2 affected / 101 at risk

Adverse event: Injection site warmth - Primary Study
Serious: no
Organ System: General disorders
Frequency: 1 affected / 101 at risk

Adverse event: Chills - Primary Study
Serious: no
Organ System: General disorders
Frequency: 1 affected / 101 at risk

Adverse event: Feeling cold - Primary Study
Serious: no
Organ System: General disorders
Frequency: 1 affected / 101 at risk

Adverse event: Hangover - Primary Study
Serious: no
Organ System: General disorders
Frequency: 1 affected / 101 at risk

Adverse event: Injection site discomfort - Primary Study
Serious: no
Organ System: General disorders
Frequency: 1 affected / 101 at risk

Adverse event: Injection site haematoma - Primary Study
Serious: no
Organ System: General disorders
Frequency: 1 affected / 101 at risk

Adverse event: Headache - Primary Study
Serious: no
Organ System: Nervous system disorders
Frequency: 47 affected / 101 at risk

Adverse event: Dizziness - Primary Study
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 101 at risk

Adverse event: Migraine - Primary Study
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 101 at risk

Adverse event: Gastrointestinal disorder - Primary Study
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 101 at risk

Adverse event: Toothache - Primary Study
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 101 at risk

Adverse event: Abdominal distension - Primary Study
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 101 at risk

Adverse event: Diarrhoea - Primary Study
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 101 at risk

Adverse event: Upper respiratory tract infection - Primary Study
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 101 at risk

Adverse event: Nasopharyngitis - Primary Study
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Rhinitis - Primary Study
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Gastroenteritis - Primary Study
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Conjunctivitis - Primary Study
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Pharyngitis bacterial - Primary Study
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Pharyngitis streptococcal - Primary Study
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Viral infection - Primary Study
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Myalgia - Primary Study
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 101 at risk

Adverse event: Arthralgia - Primary Study
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 101 at risk

Adverse event: Oropharyngeal pain - Primary Study
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 101 at risk

Adverse event: Cough - Primary Study
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 101 at risk

Adverse event: Rhinorrhoea - Primary Study
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 101 at risk

Adverse event: Rash - Primary Study
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 101 at risk

Adverse event: Procedural pain - Primary Study
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 101 at risk

Adverse event: Insomnia - Primary Study
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 101 at risk

Adverse event: Injection site pain - Extension Study
Serious: no
Organ System: General disorders
Frequency: 36 affected / 41 at risk

Adverse event: Fatigue - Extension Study
Serious: no
Organ System: General disorders
Frequency: 15 affected / 41 at risk

Adverse event: Injection site erythema - Extension Study
Serious: no
Organ System: General disorders
Frequency: 4 affected / 41 at risk

Adverse event: Injection site swelling - Extension Study
Serious: no
Organ System: General disorders
Frequency: 3 affected / 41 at risk

Adverse event: Injection site pruritus - Extension Study
Serious: no
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Inflammation - Extension Study
Serious: no
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Headache - Extension Study
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 41 at risk

Adverse event: Gastrointestinal disorder - Extension Study
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 41 at risk

Adverse event: Tonsillitis - Extension Study
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Oropharyngeal pain - Extension Study
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 41 at risk

Adverse event: Myalgia - Extension Study
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Night sweats - Extension Study
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Injection site pain - Primary Study
Serious: no
Organ System: General disorders
Frequency: 84 affected / 103 at risk

Adverse event: Fatigue - Primary Study
Serious: no
Organ System: General disorders
Frequency: 39 affected / 103 at risk

Adverse event: Injection site erythema - Primary Study
Serious: no
Organ System: General disorders
Frequency: 8 affected / 103 at risk

Adverse event: Injection site swelling - Primary Study
Serious: no
Organ System: General disorders
Frequency: 3 affected / 103 at risk

Adverse event: Pyrexia - Primary Study
Serious: no
Organ System: General disorders
Frequency: 3 affected / 103 at risk

Adverse event: Injection site bruising - Primary Study
Serious: no
Organ System: General disorders
Frequency: 4 affected / 103 at risk

Adverse event: Administration site pain - Primary Study
Serious: no
Organ System: General disorders
Frequency: 3 affected / 103 at risk

Adverse event: Administration site erythema - Primary Study
Serious: no
Organ System: General disorders
Frequency: 4 affected / 103 at risk

Adverse event: Administration site swelling - Primary Study
Serious: no
Organ System: General disorders
Frequency: 4 affected / 103 at risk

Adverse event: Injection site haemorrhage - Primary Study
Serious: no
Organ System: General disorders
Frequency: 1 affected / 103 at risk

Adverse event: Vaccination site nodule - Primary Study
Serious: no
Organ System: General disorders
Frequency: 2 affected / 103 at risk

Adverse event: Axillary pain - Primary Study
Serious: no
Organ System: General disorders
Frequency: 1 affected / 103 at risk

Adverse event: Influenza like illness - Primary Study
Serious: no
Organ System: General disorders
Frequency: 1 affected / 103 at risk

Adverse event: Headache - Primary Study
Serious: no
Organ System: Nervous system disorders
Frequency: 38 affected / 103 at risk

Adverse event: Post-traumatic headache - Primary Study
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 103 at risk

Adverse event: Gastrointestinal disorder - Primary Study
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 103 at risk

Adverse event: Nausea - Primary Study
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Toothache - Primary Study
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Abdominal pain - Primary Study
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Upper respiratory tract infection - Primary Study
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 103 at risk

Adverse event: Urinary tract infection - Primary Study
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Pharyngitis - Primary Study
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Oral herpes - Primary Study
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Otitis media - Primary Study
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Otitis media acute - Primary Study
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Vaginitis chlamydial - Primary Study
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Vulvovaginal mycotic infection - Primary Study
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 103 at risk

Adverse event: Myalgia - Primary Study
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 103 at risk

Adverse event: Back pain - Primary Study
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 103 at risk

Adverse event: Neck pain - Primary Study
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 103 at risk

Adverse event: Pain in extremity - Primary Study
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 103 at risk

Adverse event: Oropharyngeal pain - Primary Study
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Cough - Primary Study
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Nasal congestion - Primary Study
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 103 at risk

Adverse event: Rash - Primary Study
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 103 at risk

Adverse event: Lymphadenopathy - Primary Study
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 103 at risk

Adverse event: Intermenstrual bleeding - Primary Study
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 103 at risk

Adverse event: Vaginal discharge - Primary Study
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 103 at risk

Adverse event: Insomnia - Primary Study
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 103 at risk

Adverse event: Injection site pain - Extension Study
Serious: no
Organ System: General disorders
Frequency: 37 affected / 46 at risk

Adverse event: Fatigue - Extension Study
Serious: no
Organ System: General disorders
Frequency: 17 affected / 46 at risk

Adverse event: Injection site erythema - Extension Study
Serious: no
Organ System: General disorders
Frequency: 4 affected / 46 at risk

Adverse event: Injection site swelling - Extension Study
Serious: no
Organ System: General disorders
Frequency: 4 affected / 46 at risk

Adverse event: Pyrexia - Extension Study
Serious: no
Organ System: General disorders
Frequency: 1 affected / 46 at risk

Adverse event: Malaise - Extension Study
Serious: no
Organ System: General disorders
Frequency: 1 affected / 46 at risk

Adverse event: Administration site swelling - Extension Study
Serious: no
Organ System: General disorders
Frequency: 1 affected / 46 at risk

Adverse event: Headache - Extension Study
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 46 at risk

Adverse event: Migraine with aura - Extension Study
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 46 at risk

Adverse event: Gastrointestinal disorder - Extension Study
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 46 at risk

Adverse event: Oesophageal spasm - Extension Study
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Nasopharyngitis - Extension Study
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 46 at risk

Adverse event: Sinusitis - Extension Study
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 46 at risk

Adverse event: Upper respiratory tract infection - Extension Study
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 46 at risk

Adverse event: Oropharyngeal pain - Extension Study
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Contusion - Extension Study
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 46 at risk

Adverse event: Poor quality sleep - Extension Study
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 46 at risk

Adverse event: Vision blurred - Extension Study
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 46 at risk

Adverse event: Seasonal allergy - Extension Study
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 46 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Injection site pain - Primary Study
Serious: no
Organ System: General disorders
Frequency: 60 affected / 102 at risk

Adverse event: Fatigue - Primary Study
Serious: no
Organ System: General disorders
Frequency: 34 affected / 102 at risk

Adverse event: Injection site erythema - Primary Study
Serious: no
Organ System: General disorders
Frequency: 7 affected / 102 at risk

Adverse event: Injection site swelling - Primary Study
Serious: no
Organ System: General disorders
Frequency: 6 affected / 102 at risk

Adverse event: Pyrexia - Primary Study
Serious: no
Organ System: General disorders
Frequency: 4 affected / 102 at risk

Adverse event: Injection site bruising - Primary Study
Serious: no
Organ System: General disorders
Frequency: 1 affected / 102 at risk

Adverse event: Administration site pain - Primary Study
Serious: no
Organ System: General disorders
Frequency: 1 affected / 102 at risk

Adverse event: Administration site erythema - Primary Study
Serious: no
Organ System: General disorders
Frequency: 1 affected / 102 at risk

Adverse event: Injection site pruritus - Primary Study
Serious: no
Organ System: General disorders
Frequency: 1 affected / 102 at risk

Adverse event: Injection site haemorrhage - Primary Study
Serious: no
Organ System: General disorders
Frequency: 1 affected / 102 at risk

Adverse event: Pain - Primary Study
Serious: no
Organ System: General disorders
Frequency: 1 affected / 102 at risk

Adverse event: Axillary pain - Primary Study
Serious: no
Organ System: General disorders
Frequency: 1 affected / 102 at risk

Adverse event: Chills - Primary Study
Serious: no
Organ System: General disorders
Frequency: 1 affected / 102 at risk

Adverse event: Influenza like illness - Primary Study
Serious: no
Organ System: General disorders
Frequency: 1 affected / 102 at risk

Adverse event: Headache - Primary Study
Serious: no
Organ System: Nervous system disorders
Frequency: 42 affected / 102 at risk

Adverse event: Dizziness - Primary Study
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 102 at risk

Adverse event: Sleep deficit - Primary Study
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 102 at risk

Adverse event: Gastrointestinal disorder - Primary Study
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 102 at risk

Adverse event: Nausea - Primary Study
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Hyperchlorhydria - Primary Study
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Upper respiratory tract infection - Primary Study
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 102 at risk

Adverse event: Nasopharyngitis - Primary Study
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 102 at risk

Adverse event: Urinary tract infection - Primary Study
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Sinusitis - Primary Study
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 102 at risk

Adverse event: Rhinitis - Primary Study
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Gastroenteritis - Primary Study
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 102 at risk

Adverse event: Pharyngitis - Primary Study
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Cystitis - Primary Study
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Ear infection - Primary Study
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Gingivitis - Primary Study
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Myalgia - Primary Study
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 102 at risk

Adverse event: Back pain - Primary Study
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 102 at risk

Adverse event: Arthralgia - Primary Study
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 102 at risk

Adverse event: Musculoskeletal stiffness - Primary Study
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 102 at risk

Adverse event: Oropharyngeal pain - Primary Study
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Cough - Primary Study
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 102 at risk

Adverse event: Rhinorrhoea - Primary Study
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Night sweats - Primary Study
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 102 at risk

Adverse event: Lymphadenopathy - Primary Study
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 102 at risk

Adverse event: Dysmenorrhoea - Primary Study
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 102 at risk

Adverse event: Insomnia - Primary Study
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 102 at risk

Adverse event: Palpitations - Primary Study
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 102 at risk

Adverse event: Injection site pain - Extension Study
Serious: no
Organ System: General disorders
Frequency: 35 affected / 41 at risk

Adverse event: Fatigue - Extension Study
Serious: no
Organ System: General disorders
Frequency: 19 affected / 41 at risk

Adverse event: Injection site erythema - Extension Study
Serious: no
Organ System: General disorders
Frequency: 6 affected / 41 at risk

Adverse event: Injection site swelling - Extension Study
Serious: no
Organ System: General disorders
Frequency: 2 affected / 41 at risk

Adverse event: Pyrexia - Extension Study
Serious: no
Organ System: General disorders
Frequency: 5 affected / 41 at risk

Adverse event: Injection site pruritus - Extension Study
Serious: no
Organ System: General disorders
Frequency: 2 affected / 41 at risk

Adverse event: Influenza like illness - Extension Study
Serious: no
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Injection site haemorrhage - Extension Study
Serious: no
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Pain - Extension Study
Serious: no
Organ System: General disorders
Frequency: 1 affected / 41 at risk

Adverse event: Headache - Extension Study
Serious: no
Organ System: Nervous system disorders
Frequency: 23 affected / 41 at risk

Adverse event: Gastrointestinal disorder - Extension Study
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 41 at risk

Adverse event: Pharyngitis - Extension Study
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 41 at risk

Adverse event: Nasopharyngitis - Extension Study
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Bronchitis - Extension Study
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Ear infection - Extension Study
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Gastroenteritis - Extension Study
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Pyelonephritis - Extension Study
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Nasal congestion - Extension Study
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Muscle strain - Extension Study
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 41 at risk

Adverse event: Affect lability - Extension Study
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 41 at risk

Adverse event: Ear pain - Extension Study
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 41 at risk

Adverse event: Dysmenorrhoea - Extension Study
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 41 at risk

Adverse event: Injection site pain - Primary Study
Serious: no
Organ System: General disorders
Frequency: 81 affected / 102 at risk

Adverse event: Fatigue - Primary Study
Serious: no
Organ System: General disorders
Frequency: 38 affected / 102 at risk

Adverse event: Injection site erythema - Primary Study
Serious: no
Organ System: General disorders
Frequency: 6 affected / 102 at risk

Adverse event: Injection site swelling - Primary Study
Serious: no
Organ System: General disorders
Frequency: 4 affected / 102 at risk

Adverse event: Pyrexia - Primary Study
Serious: no
Organ System: General disorders
Frequency: 7 affected / 102 at risk

Adverse event: Injection site bruising - Primary Study
Serious: no
Organ System: General disorders
Frequency: 2 affected / 102 at risk

Adverse event: Administration site pain - Primary Study
Serious: no
Organ System: General disorders
Frequency: 1 affected / 102 at risk

Adverse event: Injection site pruritus - Primary Study
Serious: no
Organ System: General disorders
Frequency: 3 affected / 102 at risk

Adverse event: Vaccination site nodule - Primary Study
Serious: no
Organ System: General disorders
Frequency: 1 affected / 102 at risk

Adverse event: Pain - Primary Study
Serious: no
Organ System: General disorders
Frequency: 1 affected / 102 at risk

Adverse event: Injection site warmth - Primary Study
Serious: no
Organ System: General disorders
Frequency: 2 affected / 102 at risk

Adverse event: Injection site induration - Primary Study
Serious: no
Organ System: General disorders
Frequency: 1 affected / 102 at risk

Adverse event: Injection site discolouration - Primary Study
Serious: no
Organ System: General disorders
Frequency: 1 affected / 102 at risk

Adverse event: Injection site rash - Primary Study
Serious: no
Organ System: General disorders
Frequency: 1 affected / 102 at risk

Adverse event: Headache - Primary Study
Serious: no
Organ System: Nervous system disorders
Frequency: 37 affected / 102 at risk

Adverse event: Dizziness - Primary Study
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 102 at risk

Adverse event: Head discomfort - Primary Study
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 102 at risk

Adverse event: Neuralgia - Primary Study
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 102 at risk

Adverse event: Gastrointestinal disorder - Primary Study
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 28 affected / 102 at risk

Adverse event: Dyspepsia - Primary Study
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 102 at risk

Adverse event: Upper respiratory tract infection - Primary Study
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 102 at risk

Adverse event: Nasopharyngitis - Primary Study
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 102 at risk

Adverse event: Urinary tract infection - Primary Study
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 102 at risk

Adverse event: Sinusitis - Primary Study
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 102 at risk

Adverse event: Rhinitis - Primary Study
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Gastroenteritis - Primary Study
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Tooth infection - Primary Study
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Bacterial vaginosis - Primary Study
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Chlamydial infection - Primary Study
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Back pain - Primary Study
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 102 at risk

Adverse event: Neck pain - Primary Study
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 102 at risk

Adverse event: Pain in jaw - Primary Study
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 102 at risk

Adverse event: Rash - Primary Study
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 102 at risk

Adverse event: Thermal burn - Primary Study
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 102 at risk

Adverse event: Injection site pain - Extension Study
Serious: no
Organ System: General disorders
Frequency: 18 affected / 46 at risk

Adverse event: Fatigue - Extension Study
Serious: no
Organ System: General disorders
Frequency: 16 affected / 46 at risk

Adverse event: Injection site erythema - Extension Study
Serious: no
Organ System: General disorders
Frequency: 1 affected / 46 at risk

Adverse event: Injection site swelling - Extension Study
Serious: no
Organ System: General disorders
Frequency: 1 affected / 46 at risk

Adverse event: Pyrexia - Extension Study
Serious: no
Organ System: General disorders
Frequency: 1 affected / 46 at risk

Adverse event: Injection site lymphadenopathy - Extension Study
Serious: no
Organ System: General disorders
Frequency: 1 affected / 46 at risk

Adverse event: Headache - Extension Study
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 46 at risk

Adverse event: Gastrointestinal disorder - Extension Study
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 46 at risk

Adverse event: Oesophageal spasm - Extension Study
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Respiratory tract infection - Extension Study
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 46 at risk

Adverse event: Rhinorrhoea - Extension Study
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Limb discomfort - Extension Study
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Myalgia - Extension Study
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Rash - Extension Study
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Hypertension - Extension Study
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 46 at risk