Study: NCT04644484

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 750 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 750 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 750 at risk

Adverse event: Bacterial pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 750 at risk

Adverse event: Escherichia urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 750 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 750 at risk

Adverse event: Infectious mononucleosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 750 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 750 at risk

Adverse event: Anal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 750 at risk

Adverse event: Gingivitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 750 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 750 at risk

Adverse event: Urethritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 750 at risk

Adverse event: Pelvic inflammatory disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 750 at risk

Adverse event: Soft tissue infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 750 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 750 at risk

Adverse event: Ureteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 750 at risk

Adverse event: Vulvovaginal candidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 750 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 750 at risk

Adverse event: Infected bite
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 750 at risk

Adverse event: Chronic gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 750 at risk

Adverse event: Haemorrhoids
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 750 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 750 at risk

Adverse event: Hypertrophic anal papilla
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 750 at risk

Adverse event: Duodenitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 750 at risk

Adverse event: Oesophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 750 at risk

Adverse event: Compression fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 750 at risk

Adverse event: Contusions
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 750 at risk

Adverse event: Pelvic fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 750 at risk

Adverse event: Spinal fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 750 at risk

Adverse event: Skull fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 750 at risk

Adverse event: Brain contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 750 at risk

Adverse event: Brain herniation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 750 at risk

Adverse event: Skin injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 750 at risk

Adverse event: Extradural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 750 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 750 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 750 at risk

Adverse event: Cervicobrachial syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 750 at risk

Adverse event: Cerebral hypoperfusion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 750 at risk

Adverse event: Radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 750 at risk

Adverse event: Lumbar radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 750 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 750 at risk

Adverse event: Spinal osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 750 at risk

Adverse event: Compartment syndrome
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 750 at risk

Adverse event: Tenosynovitis stenosans
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 750 at risk

Adverse event: Ureterolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 750 at risk

Adverse event: Renal hydrocele
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 750 at risk

Adverse event: Nephrolith
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 750 at risk

Adverse event: Renal colic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 750 at risk

Adverse event: Hydroureter
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 750 at risk

Adverse event: Nasal polyps
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 750 at risk

Adverse event: Cough variant asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 750 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 750 at risk

Adverse event: Neonatal aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 750 at risk

Adverse event: Pleurisy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 750 at risk

Adverse event: Type 2 diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 750 at risk

Adverse event: Gout
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 750 at risk

Adverse event: Hypoglycaemia neonatal
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 750 at risk

Adverse event: Pleomorphic adenoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 750 at risk

Adverse event: Carcinoid tumour of the gastrointestinal tract
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 750 at risk

Adverse event: Hyperbilirubinaemia neonatal
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 750 at risk

Adverse event: Shoulder dystocia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 750 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 750 at risk

Adverse event: Dermatitis allergic
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 750 at risk

Adverse event: Uterine polyp
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 750 at risk

Adverse event: Aortic valve disease mixed
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 750 at risk

Adverse event: Administration site swelling
Serious: no
Organ System: General disorders
Frequency: 128 affected / 750 at risk

Adverse event: Administration site pain
Serious: no
Organ System: General disorders
Frequency: 36 affected / 750 at risk

Adverse event: Administration site erythema
Serious: no
Organ System: General disorders
Frequency: 32 affected / 750 at risk

Adverse event: Administration site pruritus
Serious: no
Organ System: General disorders
Frequency: 7 affected / 750 at risk

Adverse event: Administration site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 6 affected / 750 at risk

Adverse event: Administration site paraesthesia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 750 at risk

Adverse event: Vaccination site pain
Serious: no
Organ System: General disorders
Frequency: 27 affected / 750 at risk

Adverse event: Vaccination site pruritus
Serious: no
Organ System: General disorders
Frequency: 2 affected / 750 at risk

Adverse event: Vaccination site discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 750 at risk

Adverse event: Peripheral swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 750 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 17 affected / 750 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 750 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 3 affected / 750 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 750 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 23 affected / 750 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 750 at risk

Adverse event: Running nose
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 750 at risk

Adverse event: nasal congestion.
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 750 at risk

Adverse event: Pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 750 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 750 at risk

Adverse event: Respiratory alkalosis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 750 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 750 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 30 affected / 750 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 750 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 750 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 750 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 750 at risk

Adverse event: Infected bite
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 750 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 750 at risk

Adverse event: Pericoronitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 750 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 750 at risk

Adverse event: Herpes virus infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 750 at risk

Adverse event: Parotitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 750 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 750 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 750 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 750 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 750 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 750 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 750 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 750 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 750 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 750 at risk

Adverse event: Noninfective gingivitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 750 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 750 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 750 at risk

Adverse event: Oesophagitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 750 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 750 at risk

Adverse event: Hypoaesthesia oral
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 750 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 750 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 750 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 750 at risk

Adverse event: Limb pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 750 at risk

Adverse event: Intervertebral disc protrusion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 750 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 750 at risk

Adverse event: Vertebral wedging
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 750 at risk

Adverse event: Bone hypertrophy
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 750 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 750 at risk

Adverse event: Gouty arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 750 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 750 at risk

Adverse event: Animal scratch
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 750 at risk

Adverse event: Skin injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 750 at risk

Adverse event: Craniofacial fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 750 at risk

Adverse event: Subcutaneous haematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 750 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 750 at risk

Adverse event: Wound complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 750 at risk

Adverse event: Inflammation of wound
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 750 at risk

Adverse event: Injection related reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 750 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 750 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 750 at risk

Adverse event: Dermatitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 750 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 750 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 750 at risk

Adverse event: Shock
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 750 at risk

Adverse event: Aortic dilatation
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 750 at risk

Adverse event: Nephrolith
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 750 at risk

Adverse event: Renal cyst
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 750 at risk

Adverse event: Micturition urgency
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 750 at risk

Adverse event: Frequent Micturition
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 750 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 750 at risk

Adverse event: Gout
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 750 at risk

Adverse event: Metabolic acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 750 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 750 at risk

Adverse event: Spinal X-ray abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 750 at risk

Adverse event: Ultrasound prostate abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 750 at risk

Adverse event: Breast hyperplasia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 750 at risk

Adverse event: Ovarian cyst
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 750 at risk

Adverse event: Vulvovaginal pruritus
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 750 at risk

Adverse event: Hypomenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 750 at risk

Adverse event: Gallbladder polyp
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 750 at risk

Adverse event: Fatty degeneration of liver
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 750 at risk

Adverse event: Atrial enlargement
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 750 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 750 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 750 at risk

Adverse event: Poor quality sleep
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 750 at risk

Adverse event: Fear of injection
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 750 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 750 at risk

Adverse event: Tracheal operation
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 750 at risk

Adverse event: Accessory breast
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 750 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 750 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 250 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 250 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 250 at risk

Adverse event: Scrub typhus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 250 at risk

Adverse event: Chronic gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 250 at risk

Adverse event: Haemorrhoids
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 250 at risk

Adverse event: Gastric polyps
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 250 at risk

Adverse event: Craniocerebral Trauma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 250 at risk

Adverse event: Skin laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 250 at risk

Adverse event: Snake bite
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 250 at risk

Adverse event: Limb injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 250 at risk

Adverse event: Sciatica
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 250 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 250 at risk

Adverse event: Spinal osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 250 at risk

Adverse event: Vertebral end plate inflammation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 250 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 250 at risk

Adverse event: Lumbar spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 250 at risk

Adverse event: Pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 250 at risk

Adverse event: Lung adenocarcinoma stage I
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 250 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 250 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 250 at risk

Adverse event: Gestational hypertension
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 250 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 250 at risk

Adverse event: Hyperthyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 250 at risk

Adverse event: Varicose vein
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 250 at risk

Adverse event: Administration site swelling
Serious: no
Organ System: General disorders
Frequency: 87 affected / 250 at risk

Adverse event: Administration site pain
Serious: no
Organ System: General disorders
Frequency: 20 affected / 250 at risk

Adverse event: Administration site erythema
Serious: no
Organ System: General disorders
Frequency: 15 affected / 250 at risk

Adverse event: Administration site pruritus
Serious: no
Organ System: General disorders
Frequency: 6 affected / 250 at risk

Adverse event: Administration site paraesthesia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 250 at risk

Adverse event: Vaccination site pain
Serious: no
Organ System: General disorders
Frequency: 12 affected / 250 at risk

Adverse event: Vaccination site pruritus
Serious: no
Organ System: General disorders
Frequency: 3 affected / 250 at risk

Adverse event: Vaccination site rash
Serious: no
Organ System: General disorders
Frequency: 1 affected / 250 at risk

Adverse event: Vaccination site swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 250 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 250 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 250 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 2 affected / 250 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 250 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 250 at risk

Adverse event: Running nose
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 250 at risk

Adverse event: Dry throat
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 250 at risk

Adverse event: nasal congestion.
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 250 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 250 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 250 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 250 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 250 at risk

Adverse event: Infected bite
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 250 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 250 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 250 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 250 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 250 at risk

Adverse event: Mouth ulceration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 250 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 250 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 250 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 250 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 250 at risk

Adverse event: Dental paraesthesia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 250 at risk

Adverse event: Gingival swelling
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 250 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 250 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 250 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 250 at risk

Adverse event: Limb pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 250 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 250 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 250 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 250 at risk

Adverse event: Animal scratch
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 250 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 250 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 250 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 250 at risk

Adverse event: Pallor
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 250 at risk

Adverse event: Renal cyst
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 250 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 250 at risk

Adverse event: Blood zinc abnormal
Serious: no
Organ System: Investigations
Frequency: 1 affected / 250 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 250 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 250 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 250 at risk

Adverse event: Autoimmune thyroiditis
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 250 at risk