Study: NCT05788237

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 2 affected / 125 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 125 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 125 at risk

Adverse event: Vaccination site papule
Serious: no
Organ System: General disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 125 at risk

Adverse event: Odynophagia
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 125 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 125 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 4 affected / 125 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 2 affected / 125 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 125 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 125 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 125 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 2 affected / 125 at risk

Adverse event: Joint injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 125 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 125 at risk

Adverse event: Tooth fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 125 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 2 affected / 125 at risk

Adverse event: Muscle contracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 125 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 125 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 125 at risk

Adverse event: Tension headache
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 125 at risk

Adverse event: Adjustment disorder with depressed mood
Serious: no
Organ System: Psychiatric disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 125 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 125 at risk

Adverse event: Catarrh
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 15 affected / 125 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 2 affected / 125 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 2 affected / 125 at risk

Adverse event: Chills (CHILLS)
Serious: no
Organ System: General disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 34 affected / 125 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 65 affected / 125 at risk

Adverse event: Injection site erythema (REDNESS)
Serious: no
Organ System: General disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 9 affected / 125 at risk

Adverse event: Injection site pain (PAIN AT THE INJECTION SITE)
Serious: no
Organ System: General disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 88 affected / 125 at risk

Adverse event: Injection site swelling (SWELLING)
Serious: no
Organ System: General disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 12 affected / 125 at risk

Adverse event: Pyrexia (FEVER)
Serious: no
Organ System: General disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 15 affected / 125 at risk

Adverse event: Diarrhoea (DIARRHEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 9 affected / 125 at risk

Adverse event: Nausea (NAUSEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 10 affected / 125 at risk

Adverse event: Vomiting (VOMITING)
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 2 affected / 125 at risk

Adverse event: Arthralgia (NEW OR WORSENED JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 32 affected / 125 at risk

Adverse event: Myalgia (NEW OR WORSENED MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 50 affected / 125 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 61 affected / 125 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 3 affected / 121 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 121 at risk

Adverse event: Chronic gastritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 121 at risk

Adverse event: Conjunctivitis viral
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 121 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 121 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 121 at risk

Adverse event: Buttock injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 121 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 121 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 121 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 121 at risk

Adverse event: Tension headache
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 121 at risk

Adverse event: Stress urinary incontinence
Serious: no
Organ System: Renal and urinary disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 121 at risk

Adverse event: Catarrh
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 6 affected / 121 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 121 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 121 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 121 at risk

Adverse event: Chills (CHILLS)
Serious: no
Organ System: General disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 5 affected / 121 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 13 affected / 121 at risk

Adverse event: Injection site pain (PAIN AT THE INJECTION SITE)
Serious: no
Organ System: General disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 4 affected / 121 at risk

Adverse event: Injection site swelling (SWELLING)
Serious: no
Organ System: General disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 121 at risk

Adverse event: Diarrhoea (DIARRHEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 8 affected / 121 at risk

Adverse event: Nausea (NAUSEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 4 affected / 121 at risk

Adverse event: Arthralgia (NEW OR WORSENED JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 7 affected / 121 at risk

Adverse event: Myalgia (NEW OR WORSENED MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 9 affected / 121 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 20 affected / 121 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 126 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 126 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 126 at risk

Adverse event: Ventricular extrasystoles
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 126 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 126 at risk

Adverse event: Axillary pain
Serious: no
Organ System: General disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 126 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 2 affected / 126 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 126 at risk

Adverse event: Injection site lymphadenopathy
Serious: no
Organ System: General disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 126 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 126 at risk

Adverse event: Coeliac disease
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 126 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 126 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 126 at risk

Adverse event: Irritable bowel syndrome
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 126 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 126 at risk

Adverse event: Laryngitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 126 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 126 at risk

Adverse event: Pharyngotonsillitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 126 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 126 at risk

Adverse event: Vitamin D deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 126 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 126 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 126 at risk

Adverse event: Muscle contracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 3 affected / 126 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 126 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 126 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 3 affected / 126 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 126 at risk

Adverse event: Tension headache
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 126 at risk

Adverse event: Trigeminal neuralgia
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 126 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 126 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 126 at risk

Adverse event: Catarrh
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 13 affected / 126 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 126 at risk

Adverse event: Hiccups
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 126 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 126 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 2 affected / 126 at risk

Adverse event: Rash maculo-papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 2 affected / 126 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 6 affected / 126 at risk

Adverse event: Chills (CHILLS)
Serious: no
Organ System: General disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 40 affected / 125 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 61 affected / 125 at risk

Adverse event: Injection site erythema (REDNESS)
Serious: no
Organ System: General disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 11 affected / 125 at risk

Adverse event: Injection site pain (PAIN AT THE INJECTION SITE)
Serious: no
Organ System: General disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 103 affected / 125 at risk

Adverse event: Injection site swelling (SWELLING)
Serious: no
Organ System: General disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 21 affected / 125 at risk

Adverse event: Pyrexia (FEVER)
Serious: no
Organ System: General disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 28 affected / 125 at risk

Adverse event: Diarrhoea (DIARRHEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 7 affected / 125 at risk

Adverse event: Nausea (NAUSEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 11 affected / 125 at risk

Adverse event: Vomiting (VOMITING)
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 2 affected / 125 at risk

Adverse event: Arthralgia (NEW OR WORSENED JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 23 affected / 125 at risk

Adverse event: Myalgia (NEW OR WORSENED MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 47 affected / 125 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 47 affected / 125 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 116 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 116 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 116 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 116 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 116 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 2 affected / 116 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 116 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 116 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 116 at risk

Adverse event: Type 2 diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 116 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 2 affected / 116 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 116 at risk

Adverse event: Rotator cuff syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 116 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 116 at risk

Adverse event: Catarrh
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 4 affected / 116 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 116 at risk

Adverse event: Rash papular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 116 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 116 at risk

Adverse event: Chills (CHILLS)
Serious: no
Organ System: General disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 7 affected / 115 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 17 affected / 115 at risk

Adverse event: Injection site pain (PAIN AT THE INJECTION SITE)
Serious: no
Organ System: General disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 10 affected / 115 at risk

Adverse event: Injection site swelling (SWELLING)
Serious: no
Organ System: General disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 115 at risk

Adverse event: Pyrexia (FEVER)
Serious: no
Organ System: General disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 3 affected / 115 at risk

Adverse event: Diarrhoea (DIARRHEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 4 affected / 115 at risk

Adverse event: Nausea (NAUSEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 2 affected / 115 at risk

Adverse event: Arthralgia (NEW OR WORSENED JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 10 affected / 115 at risk

Adverse event: Myalgia (NEW OR WORSENED MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 13 affected / 115 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 20 affected / 115 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 101 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 101 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 101 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 2 affected / 101 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 2 affected / 101 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 101 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 101 at risk

Adverse event: Atypical pneumonia
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 101 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 2 affected / 101 at risk

Adverse event: Diverticulitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 101 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 2 affected / 101 at risk

Adverse event: Craniocerebral injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 101 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 101 at risk

Adverse event: Bone pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 101 at risk

Adverse event: Haemarthrosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 101 at risk

Adverse event: Muscle contracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 101 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 101 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 101 at risk

Adverse event: Catarrh
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 4 affected / 101 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 101 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 101 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 2 affected / 101 at risk

Adverse event: Chills (CHILLS)
Serious: no
Organ System: General disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 41 affected / 101 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 58 affected / 101 at risk

Adverse event: Injection site erythema (REDNESS)
Serious: no
Organ System: General disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 2 affected / 101 at risk

Adverse event: Injection site pain (PAIN AT THE INJECTION SITE)
Serious: no
Organ System: General disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 76 affected / 101 at risk

Adverse event: Injection site swelling (SWELLING)
Serious: no
Organ System: General disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 10 affected / 101 at risk

Adverse event: Pyrexia (FEVER)
Serious: no
Organ System: General disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 22 affected / 101 at risk

Adverse event: Diarrhoea (DIARRHEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 16 affected / 101 at risk

Adverse event: Nausea (NAUSEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 9 affected / 101 at risk

Adverse event: Arthralgia (NEW OR WORSENED JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 36 affected / 101 at risk

Adverse event: Myalgia (NEW OR WORSENED MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 49 affected / 101 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 47 affected / 101 at risk

Adverse event: Bundle branch block left
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 102 at risk

Adverse event: Cardiac septal hypertrophy
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 102 at risk

Adverse event: Dilated cardiomyopathy
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 102 at risk

Adverse event: Left atrial dilatation
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 102 at risk

Adverse event: Mitral valve incompetence
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 102 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 3 affected / 102 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 9 affected / 102 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 102 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 102 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 102 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 102 at risk

Adverse event: Localised infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 102 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 102 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 2 affected / 102 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 102 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 102 at risk

Adverse event: Troponin T increased
Serious: no
Organ System: Investigations
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 102 at risk

Adverse event: Costochondritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 102 at risk

Adverse event: Rotator cuff syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 102 at risk

Adverse event: Spinal osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 102 at risk

Adverse event: Renal disorder
Serious: no
Organ System: Renal and urinary disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 102 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 102 at risk

Adverse event: Catarrh
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 12 affected / 102 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 1 affected / 102 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 2 affected / 102 at risk

Adverse event: Chills (CHILLS)
Serious: no
Organ System: General disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 33 affected / 102 at risk

Adverse event: Fatigue (FATIGUE)
Serious: no
Organ System: General disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 62 affected / 102 at risk

Adverse event: Injection site erythema (REDNESS)
Serious: no
Organ System: General disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 6 affected / 102 at risk

Adverse event: Injection site pain (PAIN AT THE INJECTION SITE)
Serious: no
Organ System: General disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 80 affected / 102 at risk

Adverse event: Injection site swelling (SWELLING)
Serious: no
Organ System: General disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 14 affected / 102 at risk

Adverse event: Pyrexia (FEVER)
Serious: no
Organ System: General disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 13 affected / 102 at risk

Adverse event: Diarrhoea (DIARRHEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 14 affected / 102 at risk

Adverse event: Nausea (NAUSEA)
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 15 affected / 102 at risk

Adverse event: Vomiting (VOMITING)
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 3 affected / 102 at risk

Adverse event: Arthralgia (NEW OR WORSENED JOINT PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 30 affected / 102 at risk

Adverse event: Myalgia (NEW OR WORSENED MUSCLE PAIN)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 46 affected / 102 at risk

Adverse event: Headache (HEADACHE)
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v26.0 for SSA, MedDRA v26.1 for SSB
Frequency: 45 affected / 102 at risk