Study: NCT02561195

Adverse event: Blood folate decreased
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: 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 / 52 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 / 52 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 / 52 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 / 52 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 / 52 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: 1 affected / 52 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 / 52 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: 1 affected / 52 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 / 52 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 / 52 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 / 52 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 / 52 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 / 52 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: 5 affected / 52 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 / 52 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: 12 affected / 52 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: 1 affected / 52 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: 7 affected / 52 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 / 52 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: 8 affected / 52 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 / 52 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: 4 affected / 52 at risk

Adverse event: Foot 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 / 52 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 / 58 at risk

Adverse event: Pericarditis
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 / 58 at risk

Adverse event: Small 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 / 58 at risk

Adverse event: Cholecystitis acute
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 / 58 at risk

Adverse event: Staphylococcal osteomyelitis
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 / 58 at risk

Adverse event: Musculoskeletal chest pain
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 / 58 at risk

Adverse event: Hypoglycaemic 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 / 58 at risk

Adverse event: Sciatica
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 / 58 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 / 58 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: 4 affected / 58 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 / 58 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 / 58 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 / 58 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 / 58 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 / 58 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 / 58 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 / 58 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 / 58 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 / 58 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: 1 affected / 58 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 / 58 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: 2 affected / 58 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 / 58 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 / 58 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: 14 affected / 58 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: 7 affected / 58 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: 10 affected / 58 at risk

Adverse event: Macular cyst
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 / 58 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 / 59 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 / 59 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 / 59 at risk

Adverse event: Pyelonephritis
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 / 59 at risk

Adverse event: Traumatic arthrosis
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 / 59 at risk

Adverse event: Lymphoma
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 / 59 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 / 59 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 / 59 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 / 59 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 / 59 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 / 59 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 / 59 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 / 59 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 / 59 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: 2 affected / 59 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: 1 affected / 59 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 / 59 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 / 59 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 / 59 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: 1 affected / 59 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 / 59 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: 1 affected / 59 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 / 59 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 / 59 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: 2 affected / 59 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: 12 affected / 59 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: 2 affected / 59 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: 7 affected / 59 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: 12 affected / 59 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 / 59 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: 4 affected / 59 at risk

Adverse event: Eczema
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 / 59 at risk

Adverse event: Staphylococcal 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 / 59 at risk