Adverse Events Module

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Adverse Events Module

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

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 12:58 AM
Ignite Modification Date: 2025-12-25 @ 11:12 PM
NCT ID: NCT01978093
Description: None
Frequency Threshold: 0
Time Frame: Solicited adverse events - Day 0-Day 4 Unsolicited Adverse events - Day 0- Day 31 after all vaccines post-primary and post-fourth dose. SAEs - day 0 to study end (Month 17-20)
Study: NCT01978093
Study Brief: Immunogenicity, Safety and Reactogenicity Study of GlaxoSmithKline (GSK) Biologicals' Hib-MenCY-TT (MenHibrix®) Vaccine Compared to Merck & Co, Inc. PedvaxHIB Vaccine in Healthy Infants and Toddlers 12 to 15 Months of Age
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
HibCY Group Subjects received 4 doses of Hib-MenCY-TT vaccine at Day 0, Month 2, Month 4 and Month 10-13 , 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19. 1 None 8 297 282 297 View
PedHIB Group Subjects received 3 doses of PedvaxHIB vaccine at Day 0, Month 2 and Month 10-13, 3 doses of Pediarix vaccine at Day 0, Month 2 and Month 4, 2 doses of Rotarix vaccine at Day 0 and Month 2, 4 doses of Prevnar 13 vaccine at Day 0 and Month 2, Month 4 and Month 10-13 and 2 doses of Havrix vaccine at Month 10-13 and Month 16-19. 0 None 11 303 291 303 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Histiocytosis haematophagic SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypothermia SYSTEMATIC_ASSESSMENT General disorders None View
Sudden infant death syndrome SYSTEMATIC_ASSESSMENT General disorders None View
Croup infectious SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory syncytial virus bronchiolitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Subcutaneous abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Accidental overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Failure to thrive SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypernatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Ketoacidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Type 1 diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Apparent life threatening event SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Kawasaki's disease SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abnormal faeces SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acarodermatitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Accidental exposure to product SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Acne SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Administration site haemorrhage SYSTEMATIC_ASSESSMENT General disorders None View
Administration site rash SYSTEMATIC_ASSESSMENT General disorders None View
Aerophagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anal fissure SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Animal bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Ankyloglossia congenital SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Aphonia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Arthropod bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Blister SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Body height below normal SYSTEMATIC_ASSESSMENT Investigations None View
Body temperature increased SYSTEMATIC_ASSESSMENT Investigations None View
Body tinea SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bronchial hyperreactivity SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bronchiolitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Burns second degree SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Cafe au lait spots SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Candida infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Candida nappy rash SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cardiac murmur SYSTEMATIC_ASSESSMENT Investigations None View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cerumen impaction SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Communication disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Congenital torticollis SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Conjunctivitis allergic SYSTEMATIC_ASSESSMENT Eye disorders None View
Conjunctivitis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Coxsackie viral infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Craniosynostosis SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Croup infectious SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cyanosis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dacryocystitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Dacryostenosis acquired SYSTEMATIC_ASSESSMENT Eye disorders None View
Dacryostenosis congenital SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dermatitis atopic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dermatitis diaper SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Developmental hip dysplasia SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Drug hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Ear injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Erythema infectiosum SYSTEMATIC_ASSESSMENT Infections and infestations None View
Exanthema subitum SYSTEMATIC_ASSESSMENT Infections and infestations None View
Eye discharge SYSTEMATIC_ASSESSMENT Eye disorders None View
Eye infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Eye injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Failure to thrive SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Feeding disorder SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders None View
Fontanelle depressed SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Food allergy SYSTEMATIC_ASSESSMENT Immune system disorders None View
Foreign body in gastrointestinal tract SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Frenulum breve SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Fungal infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fungal skin infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Furuncle SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Genital labial adhesions SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Genital rash SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Gingival pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Haemangioma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hand-foot-and-mouth disease SYSTEMATIC_ASSESSMENT Infections and infestations None View
Head injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Herpangina SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hydrocele SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hypermetropia SYSTEMATIC_ASSESSMENT Eye disorders None View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders None View
Hypothyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Ill-defined disorder SYSTEMATIC_ASSESSMENT General disorders None View
Impetigo SYSTEMATIC_ASSESSMENT Infections and infestations None View
Increased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Increased upper airway secretion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations None View
Ingrowing nail SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Injection site bruising SYSTEMATIC_ASSESSMENT General disorders None View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders None View
Injection site induration SYSTEMATIC_ASSESSMENT General disorders None View
Injection site mass SYSTEMATIC_ASSESSMENT General disorders None View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders None View
Injection site rash SYSTEMATIC_ASSESSMENT General disorders None View
Injection site reaction SYSTEMATIC_ASSESSMENT General disorders None View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders None View
Injection site warmth SYSTEMATIC_ASSESSMENT General disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Iron deficiency anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Keratosis pilaris SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Lactose intolerance SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Language disorder SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Laryngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Laryngomalacia SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Limb injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Lip injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Macrocephaly SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Middle ear effusion SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Miliaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Milk allergy SYSTEMATIC_ASSESSMENT Immune system disorders None View
Molluscum contagiosum SYSTEMATIC_ASSESSMENT Infections and infestations None View
Motor developmental delay SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Multiple allergies SYSTEMATIC_ASSESSMENT Immune system disorders None View
Mycoplasma infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Mycoplasma test positive SYSTEMATIC_ASSESSMENT Investigations None View
Nail avulsion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Oral mucosal eruption SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oral pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oropharyngeal candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Otitis externa SYSTEMATIC_ASSESSMENT Infections and infestations None View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations None View
Otitis media acute SYSTEMATIC_ASSESSMENT Infections and infestations None View
Otorrhoea SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Paronychia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Penile adhesion SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Periorbital cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Peripheral swelling SYSTEMATIC_ASSESSMENT General disorders None View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Plagiocephaly SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia viral SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Poor feeding infant SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Poor quality sleep SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Positional plagiocephaly SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash erythematous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash macular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Respiratory disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory syncytial virus bronchiolitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory syncytial virus infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory tract infection viral SYSTEMATIC_ASSESSMENT Infections and infestations None View
Retching SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Roseola SYSTEMATIC_ASSESSMENT Infections and infestations None View
Screaming SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders None View
Seborrhoea SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Seborrhoeic dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Selective eating disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Sinus disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Skin candida SYSTEMATIC_ASSESSMENT Infections and infestations None View
Skin discolouration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Sleep disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Sneezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Speech disorder SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Speech disorder developmental SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Staphylococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Strabismus SYSTEMATIC_ASSESSMENT Eye disorders None View
Stridor SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Tachypnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Teething SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Thermal burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Tongue injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tooth fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Torticollis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Umbilical granuloma SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Underweight SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Upper respiratory tract congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Vaccination site induration SYSTEMATIC_ASSESSMENT General disorders None View
Vaccination site nodule SYSTEMATIC_ASSESSMENT General disorders None View
Vaccination site reaction SYSTEMATIC_ASSESSMENT General disorders None View
Vaginal infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral rash SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting projectile SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vulvovaginal candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Weight SYSTEMATIC_ASSESSMENT Investigations None View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations None View
Weight gain poor SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View