Study: NCT02561195

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 182 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 182 at risk

Adverse event: Brain neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 182 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 182 at risk

Adverse event: Invasive ductal breast carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 182 at risk

Adverse event: Pancreatic carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 182 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 182 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 182 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 182 at risk

Adverse event: Metabolic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 182 at risk

Adverse event: Myelopathy
Serious: yes
Organ System: Nervous system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 182 at risk

Adverse event: Device malfunction
Serious: yes
Organ System: Product Issues
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 182 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 182 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 182 at risk

Adverse event: Abdominal pain lower
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 182 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 4 affected / 182 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 182 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 182 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 182 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 9 affected / 182 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 4 affected / 182 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 182 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 182 at risk

Adverse event: Vessel puncture site swelling
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 182 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 4 affected / 182 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 3 affected / 182 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 182 at risk

Adverse event: Arthropod sting
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 182 at risk

Adverse event: Burns first degree
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 182 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 182 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 182 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 182 at risk

Adverse event: Road traffic accident
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 182 at risk

Adverse event: Tendon rupture
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 182 at risk

Adverse event: Thermal burn
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 182 at risk

Adverse event: Hypovolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 182 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 3 affected / 182 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 182 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 182 at risk

Adverse event: Osteoporosis postmenopausal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 182 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 182 at risk

Adverse event: Spinal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 182 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 182 at risk

Adverse event: Transient ischaemic attack
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 182 at risk

Adverse event: Adjustment disorder with mixed anxiety and depressed mood
Serious: no
Organ System: Psychiatric disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 182 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 182 at risk

Adverse event: Stress
Serious: no
Organ System: Psychiatric disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 182 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 182 at risk

Adverse event: Breast calcifications
Serious: no
Organ System: Reproductive system and breast disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 182 at risk

Adverse event: Fibrocystic breast disease
Serious: no
Organ System: Reproductive system and breast disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 182 at risk

Adverse event: Emphysema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 182 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 182 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 182 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 182 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 182 at risk

Adverse event: Pyrexia (fever)
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 182 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 35 affected / 182 at risk

Adverse event: Injection site erythema (redness)
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 10 affected / 182 at risk

Adverse event: Injection site pain (pain)
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 77 affected / 182 at risk

Adverse event: Injection site swelling (swelling)
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 11 affected / 182 at risk

Adverse event: Diarrhoea (diarrhea)
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 26 affected / 182 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 182 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 43 affected / 182 at risk

Adverse event: Arthralgia (joint pain)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 15 affected / 182 at risk

Adverse event: Myalgia (muscle pain)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 29 affected / 182 at risk

Adverse event: Atrioventricular block complete
Serious: yes
Organ System: Cardiac disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Lung adenocarcinoma stage II
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Coronary artery occlusion
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Eye haemorrhage
Serious: no
Organ System: Eye disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Retinoschisis
Serious: no
Organ System: Eye disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Anorectal disorder
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Diarrhoea haemorrhagic
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 184 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 3 affected / 184 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 9 affected / 184 at risk

Adverse event: Injection site macule
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 184 at risk

Adverse event: Injection site rash
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 184 at risk

Adverse event: Injection site warmth
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 184 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 184 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 184 at risk

Adverse event: Tenderness
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Multiple allergies
Serious: no
Organ System: Immune system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Eye infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Folliculitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Postoperative wound infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 184 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 8 affected / 184 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 184 at risk

Adverse event: Root canal infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 184 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Face injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 3 affected / 184 at risk

Adverse event: Joint injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 184 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 184 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Rib fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Gout
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 184 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 184 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Bursitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Coccydynia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 184 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Basal cell carcinoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 184 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Incontinence
Serious: no
Organ System: Renal and urinary disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Bronchitis chronic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Respiratory disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Rash pruritic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Skin ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Varicose vein
Serious: no
Organ System: Vascular disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Breast cyst
Serious: no
Organ System: Reproductive system and breast disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 184 at risk

Adverse event: Pyrexia (fever)
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 4 affected / 184 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 46 affected / 184 at risk

Adverse event: Injection site erythema (redness)
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 21 affected / 184 at risk

Adverse event: Injection site pain (pain)
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 92 affected / 184 at risk

Adverse event: Injection site swelling (swelling)
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 19 affected / 184 at risk

Adverse event: Diarrhoea (diarrhea)
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 37 affected / 184 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 5 affected / 184 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 59 affected / 184 at risk

Adverse event: Arthralgia (joint pain)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 31 affected / 184 at risk

Adverse event: Myalgia (muscle pain)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 41 affected / 184 at risk

Adverse event: Hyperthyroidism
Serious: no
Organ System: Endocrine disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Anal incontinence
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 61 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 61 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 61 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 61 at risk

Adverse event: Labyrinthitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Meniscus injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Type 2 diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Tendonitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Basal cell carcinoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Neuroma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 16 affected / 61 at risk

Adverse event: Injection site erythema (redness)
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Injection site pain (pain)
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 6 affected / 61 at risk

Adverse event: Diarrhoea (diarrhea)
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 16 affected / 61 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 61 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 20 affected / 61 at risk

Adverse event: Arthralgia (joint pain)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 6 affected / 61 at risk

Adverse event: Myalgia (muscle pain)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 8 affected / 61 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Arteriosclerosis coronary artery
Serious: yes
Organ System: Cardiac disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Coronary artery occlusion
Serious: yes
Organ System: Cardiac disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Mitral valve incompetence
Serious: yes
Organ System: Cardiac disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Kidney infection
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Chemical burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Incisional hernia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Postoperative ileus
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 183 at risk

Adverse event: Bladder cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Gastrointestinal tract adenoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Hyperthyroidism
Serious: no
Organ System: Endocrine disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 3 affected / 183 at risk

Adverse event: Abdominal pain lower
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 5 affected / 183 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 4 affected / 183 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 3 affected / 183 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 3 affected / 183 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Injection site haematoma
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 3 affected / 183 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 183 at risk

Adverse event: Vessel puncture site swelling
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 3 affected / 183 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 183 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 6 affected / 183 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 183 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 16 affected / 183 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 5 affected / 183 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 8 affected / 183 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Face injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 3 affected / 183 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 9 affected / 183 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 6 affected / 183 at risk

Adverse event: Bursitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 183 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 3 affected / 183 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 3 affected / 183 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 5 affected / 183 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 4 affected / 183 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 4 affected / 183 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 3 affected / 183 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 183 at risk

Adverse event: Aortic valve incompetence
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Cardiomegaly
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Coronary artery disease
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Extrasystoles
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Left ventricular hypertrophy
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Mitral valve calcification
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Mitral valve incompetence
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Pericardial effusion
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Right atrial dilatation
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Right ventricular dilatation
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Sinus node dysfunction
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Tricuspid valve incompetence
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Ventricular extrasystoles
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 183 at risk

Adverse event: Eustachian tube dysfunction
Serious: no
Organ System: Ear and labyrinth disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Vertigo positional
Serious: no
Organ System: Ear and labyrinth disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Eye disorder
Serious: no
Organ System: Eye disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Eye swelling
Serious: no
Organ System: Eye disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Glaucoma
Serious: no
Organ System: Eye disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Vitreous floaters
Serious: no
Organ System: Eye disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Diverticulum intestinal
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 183 at risk

Adverse event: Food poisoning
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Haemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Hiatus hernia
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 183 at risk

Adverse event: Injection site nodule
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 3 affected / 183 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Cholelithiasis
Serious: no
Organ System: Hepatobiliary disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Hepatic cyst
Serious: no
Organ System: Hepatobiliary disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Immune system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 183 at risk

Adverse event: Cystitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Gingivitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Hordeolum
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Infected bite
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Laryngitis viral
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Lip infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Localised infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Meningitis viral
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 3 affected / 183 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 4 affected / 183 at risk

Adverse event: Tooth abscess
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Epicondylitis
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Craniofacial fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Joint dislocation
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 183 at risk

Adverse event: Lenticular injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Muscle injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Wrist fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Blood cholesterol increased
Serious: no
Organ System: Investigations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 4 affected / 183 at risk

Adverse event: Brain natriuretic peptide increased
Serious: no
Organ System: Investigations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Cardiac murmur
Serious: no
Organ System: Investigations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Fibrin D dimer increased
Serious: no
Organ System: Investigations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Ophthalmological examination abnormal
Serious: no
Organ System: Investigations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Prostatic specific antigen increased
Serious: no
Organ System: Investigations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Red reflex abnormal
Serious: no
Organ System: Investigations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Glucose tolerance impaired
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Hypervolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 3 affected / 183 at risk

Adverse event: Musculoskeletal discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 183 at risk

Adverse event: Osteopenia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Osteoporosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Periarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Plantar fasciitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Spinal deformity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Synovial cyst
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Tendon disorder
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Trigger finger
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Muscle tightness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Breast cancer
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Cardiac neoplasm unspecified
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Skin papilloma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Squamous cell carcinoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Neuralgia
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Depressed mood
Serious: no
Organ System: Psychiatric disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 183 at risk

Adverse event: Hypertonic bladder
Serious: no
Organ System: Renal and urinary disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Nocturia
Serious: no
Organ System: Renal and urinary disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Pollakiuria
Serious: no
Organ System: Renal and urinary disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Atrophic vulvovaginitis
Serious: no
Organ System: Reproductive system and breast disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Atelectasis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Bronchial hyperreactivity
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 183 at risk

Adverse event: Paranasal cyst
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Pulmonary hypertension
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Rales
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Upper-airway cough syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Actinic keratosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 183 at risk

Adverse event: Hyperkeratosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Precancerous skin lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Psoriasis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Rosacea
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Aortic arteriosclerosis
Serious: no
Organ System: Vascular disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Aortic dilatation
Serious: no
Organ System: Vascular disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 183 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Peripheral venous disease
Serious: no
Organ System: Vascular disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 3 affected / 183 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 3 affected / 183 at risk

Adverse event: Vessel puncture site haemorrhage
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Pyrexia (fever)
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 5 affected / 183 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 52 affected / 183 at risk

Adverse event: Injection site erythema (redness)
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 11 affected / 183 at risk

Adverse event: Injection site pain (pain)
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 77 affected / 183 at risk

Adverse event: Injection site swelling (swelling)
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 10 affected / 183 at risk

Adverse event: Diarrhoea (diarrhea)
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 65 affected / 183 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 5 affected / 183 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 81 affected / 183 at risk

Adverse event: Arthralgia (joint pain)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 35 affected / 183 at risk

Adverse event: Myalgia (muscle pain)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 47 affected / 183 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Meningoencephalitis viral
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Face injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Intervertebral disc degeneration
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Spondylitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Spondylolisthesis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Intraductal proliferative breast lesion
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Amyotrophic lateral sclerosis
Serious: yes
Organ System: Nervous system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Carotid artery disease
Serious: yes
Organ System: Nervous system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Urinary tract obstruction
Serious: yes
Organ System: Renal and urinary disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Uterine prolapse
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Hyperthyroidism
Serious: no
Organ System: Endocrine disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Abdominal pain lower
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Anal incontinence
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 4 affected / 183 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 183 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 3 affected / 183 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 183 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 183 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 5 affected / 183 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 3 affected / 183 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 183 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 17 affected / 183 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 183 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 4 affected / 183 at risk

Adverse event: Arthropod bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Arthropod sting
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 3 affected / 183 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 4 affected / 183 at risk

Adverse event: Joint injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 183 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 183 at risk

Adverse event: Meniscus injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 3 affected / 183 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 3 affected / 183 at risk

Adverse event: Rib fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Road traffic accident
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Type 2 diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 5 affected / 183 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 3 affected / 183 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 9 affected / 183 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 3 affected / 183 at risk

Adverse event: Osteoarthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 4 affected / 183 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 6 affected / 183 at risk

Adverse event: Basal cell carcinoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 183 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 3 affected / 183 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 6 affected / 183 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 183 at risk

Adverse event: Breast calcifications
Serious: no
Organ System: Reproductive system and breast disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 3 affected / 183 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 3 affected / 183 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 183 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 3 affected / 183 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Cardiomegaly
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Factor V deficiency
Serious: no
Organ System: Congenital, familial and genetic disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Cerumen impaction
Serious: no
Organ System: Ear and labyrinth disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Glaucoma
Serious: no
Organ System: Eye disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Retinal vein occlusion
Serious: no
Organ System: Eye disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Abdominal mass
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Anal fissure
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Change of bowel habit
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Cheilitis
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Dental caries
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 3 affected / 183 at risk

Adverse event: Eructation
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Food poisoning
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Tooth disorder
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Drug intolerance
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Facial pain
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Injection site discolouration
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Injection site erosion
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Injection site nodule
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 183 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Hepatomegaly
Serious: no
Organ System: Hepatobiliary disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Food allergy
Serious: no
Organ System: Immune system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Acute sinusitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Body tinea
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 183 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Furuncle
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Infected dermal cyst
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Onychomycosis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 183 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Periodontitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Tinea pedis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Varicella zoster virus infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Animal bite
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Burns second degree
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 183 at risk

Adverse event: Concussion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Epicondylitis
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Head injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Post procedural complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Vitreous injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Wrist fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Blood pressure increased
Serious: no
Organ System: Investigations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 183 at risk

Adverse event: Cardiac murmur
Serious: no
Organ System: Investigations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 183 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 183 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Vitamin D deficiency
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Arthropathy
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Bone cyst
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Muscular weakness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 7 affected / 183 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Osteopenia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 3 affected / 183 at risk

Adverse event: Plantar fasciitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Spinal stenosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Trigger finger
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Joint swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 3 affected / 183 at risk

Adverse event: Hypergammaglobulinaemia benign monoclonal
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Lipoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Melanocytic naevus
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 183 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Lumbar radiculopathy
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 4 affected / 183 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Adjustment disorder with depressed mood
Serious: no
Organ System: Psychiatric disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Renal cyst
Serious: no
Organ System: Renal and urinary disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Renal impairment
Serious: no
Organ System: Renal and urinary disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Miliaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Papule
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Skin lesion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 7 affected / 183 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: no
Organ System: Vascular disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Abdominal neoplasm
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Adenoma benign
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Pulmonary embolism
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 183 at risk

Adverse event: Pyrexia (fever)
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 183 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 56 affected / 183 at risk

Adverse event: Injection site erythema (redness)
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 11 affected / 183 at risk

Adverse event: Injection site pain (pain)
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 83 affected / 183 at risk

Adverse event: Injection site swelling (swelling)
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 16 affected / 183 at risk

Adverse event: Diarrhoea (diarrhea)
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 59 affected / 183 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 4 affected / 183 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 69 affected / 183 at risk

Adverse event: Arthralgia (joint pain)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 45 affected / 183 at risk

Adverse event: Myalgia (muscle pain)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 42 affected / 183 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Tooth infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 5 affected / 61 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 5 affected / 61 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 61 at risk

Adverse event: Arthropod sting
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Hypercholesterolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Supraventricular extrasystoles
Serious: no
Organ System: Cardiac disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Meniere's disease
Serious: no
Organ System: Ear and labyrinth disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Hypogonadism
Serious: no
Organ System: Endocrine disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Neovascular age-related macular degeneration
Serious: no
Organ System: Eye disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Hiatus hernia
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Hepatitis
Serious: no
Organ System: Hepatobiliary disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Clostridium difficile infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Diverticulitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Furuncle
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 3 affected / 61 at risk

Adverse event: Localised infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Ligament rupture
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Cardiac murmur
Serious: no
Organ System: Investigations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 61 at risk

Adverse event: Food intolerance
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Hyperlipidaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Rotator cuff syndrome
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Squamous cell carcinoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Sciatica
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Panic attack
Serious: no
Organ System: Psychiatric disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Cystitis noninfective
Serious: no
Organ System: Renal and urinary disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Upper-airway cough syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Alopecia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Disturbance in attention
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 23 affected / 61 at risk

Adverse event: Injection site erythema (redness)
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 61 at risk

Adverse event: Injection site pain (pain)
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 9 affected / 61 at risk

Adverse event: Diarrhoea (diarrhea)
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 17 affected / 61 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 61 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 24 affected / 61 at risk

Adverse event: Arthralgia (joint pain)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 9 affected / 61 at risk

Adverse event: Myalgia (muscle pain)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 11 affected / 61 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 16 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 16 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 16 at risk

Adverse event: Jaw fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 16 at risk

Adverse event: Rectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 16 at risk

Adverse event: Aortic aneurysm
Serious: yes
Organ System: Vascular disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 16 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 16 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 16 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 16 at risk

Adverse event: Injection site pain (pain)
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 16 at risk

Adverse event: Diarrhoea (diarrhea)
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 16 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 6 affected / 16 at risk

Adverse event: Arthralgia (joint pain)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 16 at risk

Adverse event: Myalgia (muscle pain)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 16 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 18 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 18 at risk

Adverse event: Sinus arrest
Serious: yes
Organ System: Cardiac disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 18 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 18 at risk

Adverse event: Injection site pain (pain)
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 18 at risk

Adverse event: Diarrhoea (diarrhea)
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 3 affected / 18 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 18 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 5 affected / 18 at risk

Adverse event: Arthralgia (joint pain)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 18 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 24 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 24 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 24 at risk

Adverse event: Limb traumatic amputation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 24 at risk

Adverse event: Hemiplegia
Serious: yes
Organ System: Nervous system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 24 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 24 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 24 at risk

Adverse event: Dermatitis contact
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 24 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 24 at risk

Adverse event: Pyrexia (fever)
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 24 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 4 affected / 24 at risk

Adverse event: Diarrhoea (diarrhea)
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 6 affected / 24 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 24 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 24 at risk

Adverse event: Vessel puncture site erythema
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 24 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 22 at risk

Adverse event: Cardiovascular disorder
Serious: yes
Organ System: Cardiac disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 22 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 22 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 22 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 22 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 22 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 22 at risk

Adverse event: Injection site erythema (redness)
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 3 affected / 22 at risk

Adverse event: Injection site pain (pain)
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 6 affected / 22 at risk

Adverse event: Injection site swelling (swelling)
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 3 affected / 22 at risk

Adverse event: Diarrhoea (diarrhea)
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 3 affected / 22 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 22 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 4 affected / 22 at risk

Adverse event: Arthralgia (joint pain)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 22 at risk

Adverse event: Myalgia (muscle pain)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 5 affected / 22 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 22 at risk

Adverse event: Oesophageal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 51 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 51 at risk

Adverse event: B-cell type acute leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 51 at risk

Adverse event: Pulmonary thrombosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 51 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 51 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 51 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 51 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 51 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 51 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 51 at risk

Adverse event: Hordeolum
Serious: no
Organ System: Infections and infestations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 51 at risk

Adverse event: Red reflex abnormal
Serious: no
Organ System: Investigations
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 51 at risk

Adverse event: Vessel puncture site haemorrhage
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 2 affected / 51 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 6 affected / 51 at risk

Adverse event: Injection site pain (pain)
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 3 affected / 51 at risk

Adverse event: Diarrhoea (diarrhea)
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 8 affected / 51 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 9 affected / 51 at risk

Adverse event: Arthralgia (joint pain)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 4 affected / 51 at risk

Adverse event: Myalgia (muscle pain)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 3 affected / 51 at risk

Adverse event: Aphthous ulcer
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 51 at risk

Adverse event: Allergy to animal
Serious: no
Organ System: Immune system disorders
Notes: MedDRA v20.0 was used for coding events till Vaccination 1 to 3 and MedDRA v23.0 was used for coding events Extension Stage (Vaccination 4).
Frequency: 1 affected / 51 at risk