Study: NCT04546425

Adverse event: Lymphadenitis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 601 at risk

Adverse event: Aorticopulmonary septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 601 at risk

Adverse event: Bronchogenic cyst
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 601 at risk

Adverse event: Bacterial infection
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 601 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 2 affected / 601 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 601 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 4 affected / 601 at risk

Adverse event: Gastrointestinal infection
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 2 affected / 601 at risk

Adverse event: Herpangina
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 601 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 601 at risk

Adverse event: Meningitis
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 601 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 601 at risk

Adverse event: Pneumonia respiratory syncytial viral
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 601 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 601 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 601 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 2 affected / 601 at risk

Adverse event: Skin infection
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 601 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 4 affected / 601 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 3 affected / 601 at risk

Adverse event: Skull fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 601 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 601 at risk

Adverse event: Type 1 diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 601 at risk

Adverse event: Underweight
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 601 at risk

Adverse event: Benign salivary gland neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 601 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 601 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 601 at risk

Adverse event: Intracranial pressure increased
Serious: yes
Organ System: Nervous system disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 601 at risk

Adverse event: Tubulointerstitial nephritis
Serious: yes
Organ System: Renal and urinary disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 601 at risk

Adverse event: Vesicoureteric reflux
Serious: yes
Organ System: Renal and urinary disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 601 at risk

Adverse event: Bronchial hyperreactivity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 601 at risk

Adverse event: Inflammation
Serious: yes
Organ System: General disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 601 at risk

Adverse event: Decreased appetite (DECREASED APPETITE)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 345 affected / 601 at risk

Adverse event: Hypersomnia (INCREASED SLEEP)
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 495 affected / 601 at risk

Adverse event: Irritability (IRRITABILITY)
Serious: no
Organ System: Psychiatric disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 553 affected / 601 at risk

Adverse event: Injection site erythema (REDNESS)
Serious: no
Organ System: General disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 331 affected / 601 at risk

Adverse event: Injection site pain (PAIN)
Serious: no
Organ System: General disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 343 affected / 601 at risk

Adverse event: Injection site swelling (SWELLING)
Serious: no
Organ System: General disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 260 affected / 601 at risk

Adverse event: Pyrexia (FEVER)
Serious: no
Organ System: General disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 212 affected / 601 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 21 affected / 601 at risk

Adverse event: Lymphadenitis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 603 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 603 at risk

Adverse event: Thymus enlargement
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 603 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 603 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 603 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 2 affected / 603 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 603 at risk

Adverse event: Erythema infectiosum
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 603 at risk

Adverse event: Escherichia urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 2 affected / 603 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 5 affected / 603 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 603 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 603 at risk

Adverse event: Gastrointestinal infection
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 2 affected / 603 at risk

Adverse event: Gastrointestinal viral infection
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 603 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 2 affected / 603 at risk

Adverse event: Lower respiratory tract infection viral
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 603 at risk

Adverse event: Meningitis enteroviral
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 603 at risk

Adverse event: Oral candidiasis
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 603 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 603 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 3 affected / 603 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 603 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 603 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 4 affected / 603 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 603 at risk

Adverse event: Foreign body aspiration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 603 at risk

Adverse event: Feeding disorder
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 3 affected / 603 at risk

Adverse event: Poor feeding infant
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 603 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 603 at risk

Adverse event: Hypotonia
Serious: yes
Organ System: Nervous system disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 603 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 603 at risk

Adverse event: Nephritis
Serious: yes
Organ System: Renal and urinary disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 603 at risk

Adverse event: Dermatitis atopic
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 603 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 603 at risk

Adverse event: Decreased appetite (DECREASED APPETITE)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 323 affected / 603 at risk

Adverse event: Hypersomnia (INCREASED SLEEP)
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 512 affected / 603 at risk

Adverse event: Irritability (IRRITABILITY)
Serious: no
Organ System: Psychiatric disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 556 affected / 603 at risk

Adverse event: Injection site erythema (REDNESS)
Serious: no
Organ System: General disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 333 affected / 603 at risk

Adverse event: Injection site pain (PAIN)
Serious: no
Organ System: General disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 347 affected / 603 at risk

Adverse event: Injection site swelling (SWELLING)
Serious: no
Organ System: General disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 251 affected / 603 at risk

Adverse event: Pyrexia (FEVER)
Serious: no
Organ System: General disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 214 affected / 603 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 35 affected / 603 at risk

Adverse event: Decreased appetite (DECREASED APPETITE)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 9 affected / 24 at risk

Adverse event: Hypersomnia (INCREASED SLEEP)
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 8 affected / 24 at risk

Adverse event: Irritability (IRRITABILITY)
Serious: no
Organ System: Psychiatric disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 13 affected / 24 at risk

Adverse event: Injection site erythema (REDNESS)
Serious: no
Organ System: General disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 3 affected / 24 at risk

Adverse event: Injection site pain (PAIN)
Serious: no
Organ System: General disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 7 affected / 24 at risk

Adverse event: Injection site swelling (SWELLING)
Serious: no
Organ System: General disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 4 affected / 24 at risk

Adverse event: Pyrexia (FEVER)
Serious: no
Organ System: General disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 2 affected / 24 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 1 affected / 24 at risk

Adverse event: Decreased appetite (DECREASED APPETITE)
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 8 affected / 27 at risk

Adverse event: Hypersomnia (INCREASED SLEEP)
Serious: no
Organ System: Nervous system disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 11 affected / 27 at risk

Adverse event: Irritability (IRRITABILITY)
Serious: no
Organ System: Psychiatric disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 15 affected / 27 at risk

Adverse event: Injection site erythema (REDNESS)
Serious: no
Organ System: General disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 4 affected / 27 at risk

Adverse event: Injection site pain (PAIN)
Serious: no
Organ System: General disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 6 affected / 27 at risk

Adverse event: Injection site swelling (SWELLING)
Serious: no
Organ System: General disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 3 affected / 27 at risk

Adverse event: Pyrexia (FEVER)
Serious: no
Organ System: General disorders
Notes: MedDRA 26.0 was used for Russian Cohorts.
Frequency: 4 affected / 27 at risk