For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Maternal Participants: RSVpreF 120 mcg | Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery. | 0 | None | 7 | 115 | 87 | 115 | View |
| Maternal Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 120 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery. | 0 | None | 15 | 117 | 108 | 117 | View |
| Maternal Participants: RSVpreF 240 mcg | Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile water for injection on Day 1. Participants were followed up to 12 months after delivery. | 0 | None | 15 | 116 | 96 | 116 | View |
| Maternal Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Maternal participants received a single dose of 0.5 mL as intramuscular injection of RSVpreF vaccine 240 mcg reconstituted with sterile suspension of aluminum hydroxide in water for injection on Day 1. Participants were followed up to 12 months after delivery. | 0 | None | 19 | 114 | 103 | 114 | View |
| Maternal Participants: Placebo | Maternal participants received a single dose of 0.5 mL as intramuscular injection of placebo (normal sterile saline solution) on Day 1. Participants were followed up to 12 months after delivery. | 0 | None | 14 | 117 | 89 | 117 | View |
| Infant Participants: RSVpreF 120 mcg | Infant participants who were born to maternal participants vaccinated with RSVpreF 120 mcg (reconstituted with sterile water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth. | 0 | None | 41 | 114 | 66 | 114 | View |
| Infant Participants: RSVpreF 240 mcg | Infant participants who were born to maternal participants vaccinated with RSVpreF 240 mcg (reconstituted with sterile water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth. | 0 | None | 35 | 113 | 67 | 113 | View |
| Infant Participants: RSVpreF 240 mcg With Aluminum Hydroxide | Infant participants who were born to maternal participants vaccinated with RSVpreF 240 mcg (reconstituted with sterile suspension of aluminum hydroxide in water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth. | 0 | None | 44 | 112 | 66 | 112 | View |
| Infant Participants: Placebo | Infant participants who were born to maternal participants administered with placebo (normal sterile saline solution) during pregnancy were included. Infant participants were followed up to 12 months after birth. | 0 | None | 38 | 116 | 71 | 116 | View |
| Infant Participants: RSVpreF 120 mcg With Aluminum Hydroxide | Infant participants who were born to maternal participants vaccinated with RSVpreF 120 mcg (reconstituted with sterile suspension of aluminum hydroxide in water for injection) during pregnancy were included. Infant participants were followed up to 12 months after birth. | 0 | None | 39 | 117 | 59 | 117 | View |
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nonreassuring foetal heart rate pattern | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v24.1 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| False labour | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v24.1 | View |
| Premature delivery | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v24.1 | View |
| Cryptorchism | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v24.1 | View |
| Hyperbilirubinaemia | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v24.1 | View |
| Respiratory syncytial virus test positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v24.1 | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v24.1 | View |
| Anaemia of pregnancy | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v24.1 | View |
| Blood loss anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v24.1 | View |
| Baseline foetal heart rate variability disorder | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v24.1 | View |
| Foetal heart rate deceleration abnormality | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v24.1 | View |
| Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v24.1 | View |
| Tachycardia foetal | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v24.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v24.1 | View |
| Cholecystitis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v24.1 | View |
| Amniotic cavity infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Anorectal cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Appendicitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Endometritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Endometritis decidual | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Mastitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Oophoritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Pyelonephritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Salpingitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Joint dislocation | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v24.1 | View |
| Procedural haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v24.1 | View |
| Uterine rupture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v24.1 | View |
| Body temperature increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v24.1 | View |
| Foetal heart rate decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v24.1 | View |
| Foetal heart rate indeterminate | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v24.1 | View |
| Influenza virus test positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v24.1 | View |
| Osteitis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v24.1 | View |
| Migraine | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v24.1 | View |
| Arrested labour | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v24.1 | View |
| Cephalo-pelvic disproportion | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v24.1 | View |
| Ectopic pregnancy | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v24.1 | View |
| Foetal death | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v24.1 | View |
| Foetal distress syndrome | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v24.1 | View |
| Foetal growth restriction | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v24.1 | View |
| Foetal hypokinesia | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v24.1 | View |
| Gestational hypertension | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v24.1 | View |
| Oligohydramnios | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v24.1 | View |
| Postpartum haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v24.1 | View |
| Pre-eclampsia | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v24.1 | View |
| Premature labour | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v24.1 | View |
| Premature separation of placenta | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v24.1 | View |
| Prolonged rupture of membranes | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v24.1 | View |
| Retained placenta or membranes | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v24.1 | View |
| Umbilical cord abnormality | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v24.1 | View |
| Uterine tachysystole | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v24.1 | View |
| Vaginal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v24.1 | View |
| Pulmonary hypertension | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v24.1 | View |
| Disseminated intravascular coagulation | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v24.1 | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v24.1 | View |
| Mitral valve incompetence | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v24.1 | View |
| Alpers disease | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v24.1 | View |
| Ankyloglossia congenital | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v24.1 | View |
| Aplasia cutis congenita | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v24.1 | View |
| Atrial septal defect | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v24.1 | View |
| Birth mark | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v24.1 | View |
| Chordee | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v24.1 | View |
| Chromosomal deletion | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v24.1 | View |
| Cleft lip | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v24.1 | View |
| Cleft palate | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v24.1 | View |
| Congenital coronary artery malformation | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v24.1 | View |
| Congenital naevus | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v24.1 | View |
| Congenital skin dimples | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v24.1 | View |
| Congenital tracheomalacia | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v24.1 | View |
| Congenital umbilical hernia | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v24.1 | View |
| Cystic fibrosis | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v24.1 | View |
| Dacryostenosis congenital | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v24.1 | View |
| Developmental hip dysplasia | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v24.1 | View |
| Double ureter | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v24.1 | View |
| Gastrointestinal disorder congenital | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v24.1 | View |
| Haemoglobin D trait | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v24.1 | View |
| Hydrocele | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v24.1 | View |
| Hypospadias | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v24.1 | View |
| Labial tie | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v24.1 | View |
| Laryngomalacia | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v24.1 | View |
| Naevus flammeus | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v24.1 | View |
| Patent ductus arteriosus | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v24.1 | View |
| Penile torsion | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v24.1 | View |
| Penoscrotal fusion | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v24.1 | View |
| Phimosis | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v24.1 | View |
| Polydactyly | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v24.1 | View |
| Spina bifida cystica | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v24.1 | View |
| Supernumerary nipple | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v24.1 | View |
| Vascular malformation | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v24.1 | View |
| Ventricular septal defect | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v24.1 | View |
| XYY syndrome | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA v24.1 | View |
| Gingival cyst | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Intussusception | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Tongue cyst | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Umbilical hernia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Hypothermia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v24.1 | View |
| Infusion site extravasation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v24.1 | View |
| Jaundice | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v24.1 | View |
| Adenovirus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Bronchiolitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| COVID-19 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Croup infectious | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Gastroenteritis salmonella | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Gastroenteritis viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Respiratory syncytial virus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Viral upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Postoperative adhesion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v24.1 | View |
| Skull fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v24.1 | View |
| Acoustic stimulation tests abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v24.1 | View |
| Cardiac murmur | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v24.1 | View |
| Cardiac murmur functional | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v24.1 | View |
| Right ventricular systolic pressure | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v24.1 | View |
| Hypoglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v24.1 | View |
| Metabolic acidosis | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v24.1 | View |
| Acrochordon | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.1 | View |
| Haemangioma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.1 | View |
| Haemangioma of skin | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.1 | View |
| Melanocytic naevus | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.1 | View |
| Brain hypoxia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v24.1 | View |
| Clonic convulsion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v24.1 | View |
| Encephalopathy neonatal | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v24.1 | View |
| Hydrocephalus | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v24.1 | View |
| Peripheral nerve palsy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v24.1 | View |
| Seizure | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v24.1 | View |
| Jaundice neonatal | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v24.1 | View |
| Low birth weight baby | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v24.1 | View |
| Premature baby | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v24.1 | View |
| Acute kidney injury | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v24.1 | View |
| Testicular retraction | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v24.1 | View |
| Cafe au lait spots | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v24.1 | View |
| Macule | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v24.1 | View |
| Subgaleal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v24.1 | View |
| Acute respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | View |
| Hypoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | View |
| Meconium aspiration syndrome | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | View |
| Neonatal aspiration | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | View |
| Neonatal hypoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | View |
| Neonatal pneumothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | View |
| Neonatal respiratory depression | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | View |
| Neonatal respiratory distress | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | View |
| Neonatal respiratory distress syndrome | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | View |
| Neonatal respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | View |
| Pneumothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | View |
| Respiratory distress | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | View |
| Tachypnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | View |
| Transient tachypnoea of the newborn | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | View |
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v24.1 | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v24.1 | View |
| Nonreassuring foetal heart rate pattern | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v24.1 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Diarrhoea (DIARRHOEA) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Gastrooesophageal reflux disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Haemorrhoids | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Nausea (NAUSEA) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Vomiting (VOMITING) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Fatigue (FATIGUE) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v24.1 | View |
| Injection site erythema (REDNESS) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v24.1 | View |
| Injection site pain (PAIN AT INJECTION SITE) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v24.1 | View |
| Injection site swelling (SWELLING) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v24.1 | View |
| Oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v24.1 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v24.1 | View |
| Perineal injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v24.1 | View |
| Vulvovaginal injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v24.1 | View |
| Bacterial test positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v24.1 | View |
| Blood pressure increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v24.1 | View |
| SARS-CoV-2 test positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v24.1 | View |
| Streptococcus test positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v24.1 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v24.1 | View |
| Vitamin D deficiency | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v24.1 | View |
| Arthralgia (JOINT PAIN) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | View |
| Myalgia (MUSCLE PAIN) | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v24.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v24.1 | View |
| Headache (HEADACHE) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v24.1 | View |
| Migraine | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v24.1 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v24.1 | View |
| Foetal hypokinesia | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v24.1 | View |
| Gestational diabetes | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v24.1 | View |
| Gestational hypertension | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v24.1 | View |
| Premature delivery | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v24.1 | View |
| Shoulder dystocia | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v24.1 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v24.1 | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v24.1 | View |
| Perinatal depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v24.1 | View |
| Vaginal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v24.1 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | View |
| Nasal congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v24.1 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v24.1 | View |
| Ear pain | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA v24.1 | View |
| Conjunctival haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v24.1 | View |
| Dacryostenosis acquired | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v24.1 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Flatulence | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Teething | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v24.1 | View |
| Hyperbilirubinaemia | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v24.1 | View |
| Jaundice | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v24.1 | View |
| Acne infantile | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v24.1 | View |
| Dermatitis contact | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v24.1 | View |
| Dermatitis diaper | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v24.1 | View |
| Eczema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v24.1 | View |
| Seborrhoea | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v24.1 | View |
| Clavicle fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v24.1 | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v24.1 | View |
| Cardiac murmur | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v24.1 | View |
| Hypocalcaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v24.1 | View |
| Acquired plagiocephaly | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | View |
| Torticollis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | View |
| Jaundice neonatal | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v24.1 | View |
| Low birth weight baby | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v24.1 | View |
| Premature baby | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v24.1 | View |
| Umbilical granuloma | NON_SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA v24.1 | View |
| Neonatal respiratory distress syndrome | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | View |
| Respiratory disorder | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | View |
| Rhinorrhoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | View |
| Sneezing | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | View |
| Tachypnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | View |
| Transient tachypnoea of the newborn | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | View |
| Upper respiratory tract congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | View |
| Wheezing | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | View |
| Bronchiolitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Candida infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Conjunctivitis bacterial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Croup infectious | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Ear infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Folliculitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Oral candidiasis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Otitis media | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Otitis media acute | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Pharyngitis streptococcal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Respiratory syncytial virus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Skin candida | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Viral infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Viral upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v24.1 | View |
| Pyrexia (FEVER) | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v24.1 | View |
| Bacterial disease carrier | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Mastitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |
| Vaginal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v24.1 | View |