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:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2025-12-26 @ 11:12 AM
NCT ID:
NCT00337428
Description:
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
Frequency Threshold:
0
Time Frame:
Adverse events (AEs) were collected from Day 1 until Month 7.
Study:
NCT00337428
Study Brief:
Concomitant Use of Gardasil (V501, Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) With Combined Diptheria, Tetanus, Pertussis and Poliomyelitis Vaccine in Adolescents (V501-024)(COMPLETED)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| qHPV Vaccine + REPEVAX™ (Concomitant) | Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites. | None | None | 1 | 420 | 405 | 420 | View |
| qHPV Vaccine + REPEVAX™ (Non-Concomitant) | Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1. | None | None | 3 | 423 | 406 | 423 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 10.1 | View |
| Ligament rupture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 10.1 | View |
| Meniscus lesion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 10.1 | View |
| Upper limb fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 10.1 | View |
| Ligament disorder | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 10.1 | View |
| Hyperventilation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Ear pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Version 10.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 10.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 10.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 10.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 10.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 10.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 10.1 | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 10.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 10.1 | View |
| Injection site bruising-qHPV | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 10.1 | View |
| Injection site erythema-qHPV | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 10.1 | View |
| Injection site haematoma-qHPV | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 10.1 | View |
| Injection site induration-qHPV | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 10.1 | View |
| Injection site pain-qHPV | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 10.1 | View |
| Injection site pruritus-qHPV | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 10.1 | View |
| Injection site swelling-qHPV | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 10.1 | View |
| Injection site bruising-Repevax | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 10.1 | View |
| Injection site erythema-Repevax | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 10.1 | View |
| Injection site haematoma-Repevax | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 10.1 | View |
| Injection site induration-Repevax | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 10.1 | View |
| Injection site irritation-Repevax | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 10.1 | View |
| Injection site pain-Repevax | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 10.1 | View |
| Injection site pruritus-Repevax | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 10.1 | View |
| Injection site swelling-Repevax | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 10.1 | View |
| Injection site warmth-Repevax | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 10.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 10.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 10.1 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 10.1 | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 10.1 | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 10.1 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 10.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 10.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 10.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 10.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 10.1 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 10.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 10.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 10.1 | View |
| Dysmenorrhoea | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 10.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.1 | View |
| Pharyngolaryngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.1 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 10.1 | View |
| Cerumen impaction | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Version 10.1 | View |
| Motion sickness | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Version 10.1 | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA Version 10.1 | View |
| Abdominal pain lower | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 10.1 | View |
| Aphthous stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 10.1 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 10.1 | View |
| Enteritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 10.1 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 10.1 | View |
| Gingivitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 10.1 | View |
| Lip swelling | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 10.1 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 10.1 | View |
| Teething | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 10.1 | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 10.1 | View |
| Photophobia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 10.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 10.1 | View |
| Axillary pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 10.1 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 10.1 | View |
| Facial pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 10.1 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 10.1 | View |
| Conjunctivitis allergic | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 10.1 | View |
| Eye pain | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 10.1 | View |
| Eye pruritus | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 10.1 | View |
| Lacrimation increased | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 10.1 | View |
| Ocular discomfort | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA Version 10.1 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 10.1 | View |
| Hypochromasia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 10.1 | View |
| Lymphadenitis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 10.1 | View |
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 10.1 | View |
| Feeling cold | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 10.1 | View |
| Feeling of body temperature change | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 10.1 | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 10.1 | View |
| Local swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 10.1 | View |
| Vessel puncture site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 10.1 | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA Version 10.1 | View |
| Seasonal allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA Version 10.1 | View |
| Acute tonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 10.1 | View |
| Blister infected | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 10.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 10.1 | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 10.1 | View |
| Ear infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 10.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 10.1 | View |
| Hordeolum | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 10.1 | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 10.1 | View |
| Laryngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 10.1 | View |
| Lice infestation | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 10.1 | View |
| Localised infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 10.1 | View |
| Oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 10.1 | View |
| Otitis externa | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 10.1 | View |
| Otitis media | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 10.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 10.1 | View |
| Sialoadenitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 10.1 | View |
| Tinea versicolour | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 10.1 | View |
| Tonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 10.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 10.1 | View |
| Viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 10.1 | View |
| Viral tonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 10.1 | View |
| Vulvovaginal mycotic infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 10.1 | View |
| Incision site haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 10.1 | View |
| Arthropod bite | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 10.1 | View |
| Arthropod sting | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 10.1 | View |
| Brain contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 10.1 | View |
| Concussion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 10.1 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 10.1 | View |
| Excoriation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 10.1 | View |
| Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 10.1 | View |
| Joint injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 10.1 | View |
| Joint sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 10.1 | View |
| Muscle strain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 10.1 | View |
| Post-traumatic pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 10.1 | View |
| Procedural dizziness | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 10.1 | View |
| Procedural pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 10.1 | View |
| Thermal burn | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 10.1 | View |
| Wound | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 10.1 | View |
| Body temperature increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 10.1 | View |
| Heart rate increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA Version 10.1 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 10.1 | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 10.1 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 10.1 | View |
| Coccydynia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 10.1 | View |
| Groin pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 10.1 | View |
| Growing pains | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 10.1 | View |
| Joint swelling | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 10.1 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 10.1 | View |
| Musculoskeletal stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 10.1 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 10.1 | View |
| Sensation of heaviness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 10.1 | View |
| Tendonitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA Version 10.1 | View |
| Skin papilloma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 10.1 | View |
| Hyperaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 10.1 | View |
| Loss of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 10.1 | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 10.1 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 10.1 | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 10.1 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 10.1 | View |
| Syncope vasovagal | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 10.1 | View |
| Eating disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 10.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 10.1 | View |
| Listless | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 10.1 | View |
| Sleep disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA Version 10.1 | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 10.1 | View |
| Metrorrhagia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA Version 10.1 | View |
| Bronchitis chronic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.1 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.1 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.1 | View |
| Rhinitis allergic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.1 | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.1 | View |
| Throat irritation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.1 | View |
| Dermatitis contact | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 10.1 | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 10.1 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 10.1 | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 10.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 10.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 10.1 | View |
| Rash macular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 10.1 | View |
| Rash pruritic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 10.1 | View |
| Subcutaneous nodule | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA Version 10.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 10.1 | View |
| Injection site irritation-qHPV | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 10.1 | View |
| Injection site warmth-qHPV | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 10.1 | View |
| Injection site anaesthesia-Repevax | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 10.1 | View |
| Injection site discolouration-qHPV | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 10.1 | View |
| Injection site discolouration-Repevax | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 10.1 | View |
| Injection site haemorrhage-qHPV | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 10.1 | View |
| Injection site haemorrhage-Repevax | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 10.1 | View |
| Injection site mass-Repevax | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 10.1 | View |
| Injection site movement impairment-qHPV | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 10.1 | View |
| Injection site movement impairment-Repevax | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 10.1 | View |
| Injection site nodule-qHPV | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 10.1 | View |
| Injection site nodule-Repevax | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 10.1 | View |
| Injection site papule-Repevax | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 10.1 | View |
| Injection site rash-Repevax | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 10.1 | View |
| Injection site reaction-qHPV | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 10.1 | View |
| Injection site reaction-Repevax | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA Version 10.1 | View |