TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02054715

Adverse event: Hyponatremia, decreased WBC, post chemo
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 219 at risk

Adverse event: metastatic hepatocellular carcinoma
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Death
Frequency: 1 affected / 219 at risk

Adverse event: Perirectal abscess, large tumor with post obstructive atelectasis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Death
Frequency: 1 affected / 219 at risk

Adverse event: Extensive metastatic melanoma (to skeletal system, liver, lungs, adrenal glands, mesentery, heart)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Death
Frequency: 1 affected / 219 at risk

Adverse event: Fever post chemo
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 219 at risk

Adverse event: Metastatic melanoma to liver/ sepsis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Death
Frequency: 1 affected / 199 at risk

Adverse event: Stage IV lung cancer with widespread mets
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Death
Frequency: 1 affected / 199 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: Death
Frequency: 1 affected / 199 at risk
Study: NCT02054754

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Musculo-skeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 6 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Acute otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Pyelonephritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk
Study: NCT02055365

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: mild ecchymosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk
Study: NCT02055430

Adverse event: Pyrexia
Serious: no
Organ System: Renal and urinary disorders
Notes: febrile urinary tract infection
Frequency: 2 affected / 45 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Renal and urinary disorders
Notes: febrile urinary tract infection
Frequency: 1 affected / 45 at risk
Study: NCT02055638

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 49 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 49 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 49 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 48 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 48 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 48 at risk
Study: NCT02055872

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 24 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 21 at risk
Study: NCT02055898

Adverse event: Obstructive sleep apnoea syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 12 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: mild itchiness
Frequency: 2 affected / 12 at risk

Adverse event: painful legs at night
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Seasonal allergy
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: mild itchiness
Frequency: 1 affected / 11 at risk

Adverse event: Indigestion/upset stomach
Serious: no
Organ System: Gastrointestinal disorders
Notes: including mild nausea
Frequency: 4 affected / 11 at risk

Adverse event: central sleep apneas
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: as recorded with overnight polysomnography
Frequency: 2 affected / 11 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 2 affected / 11 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Balance disorder
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: feels confused on waking
Serious: no
Organ System: General disorders
Notes: Brief period of disorientation on waking
Frequency: 2 affected / 11 at risk
Study: NCT02055963

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Lack of appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk
Study: NCT02056171

Adverse event: Movement disorder
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3 at risk
Study: NCT02056301

Adverse event: Surgical Complications
Serious: yes
Organ System: Surgical and medical procedures
Notes: Surgical complications requiring secondary surgery
Frequency: 1 affected / 33 at risk

Adverse event: Epidural Related
Serious: no
Organ System: Surgical and medical procedures
Notes: Epidural Placement Failed or Epidural Dislodged and subject switched to IV PCA
Frequency: 3 affected / 33 at risk

Adverse event: Epidural Related
Serious: no
Organ System: Surgical and medical procedures
Notes: Epidural Placement Failed or Epidural Dislodged and subject switched to IV PCA
Frequency: 3 affected / 29 at risk
Study: NCT02056340

Adverse event: Safety lab testing AST, ALT and CK levels
Serious: no
Organ System: Hepatobiliary disorders
Notes: CK levels elevated
Frequency: 1 affected / 59 at risk

Adverse event: GI Distress
Serious: no
Organ System: Gastrointestinal disorders
Notes: Patients presenting with GI distress such as gastroenteritis, diarrhea, and yellow stool.
Frequency: 2 affected / 59 at risk

Adverse event: Facial tingling
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 59 at risk

Adverse event: Safety lab testing AST, ALT and CK levels
Serious: no
Organ System: Hepatobiliary disorders
Notes: CK levels elevated
Frequency: 2 affected / 57 at risk

Adverse event: GI Distress
Serious: no
Organ System: Gastrointestinal disorders
Notes: Patients presenting with GI distress such as gastroenteritis, diarrhea, and yellow stool.
Frequency: 1 affected / 57 at risk

Adverse event: Focal Myopathy
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 57 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Patient complained of worsening nausea and dry heaves.
Frequency: 1 affected / 57 at risk
Study: NCT02056392

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 51 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 51 at risk

Adverse event: Blister
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 51 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 51 at risk

Adverse event: Disturbance in attention
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 51 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 51 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 51 at risk

Adverse event: Haemorrhoids
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 50 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 50 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 50 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 50 at risk
Study: NCT02056431

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: We created an algorithm to extract information on all hospitalizations and deaths in our population regardless of organ system.
Frequency: 20 affected / 604 at risk

Adverse event: Any Hospitalizations Occurring During the Study Period
Serious: yes
Organ System: General disorders
Notes: We did not collect cause of death due to a 2-year lag between the time of death and assignment of the cause of death by the state.
Frequency: 118 affected / 604 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: We created an algorithm to extract information on all hospitalizations and deaths in our population regardless of organ system.
Frequency: 24 affected / 666 at risk

Adverse event: Any Hospitalizations Occurring During the Study Period
Serious: yes
Organ System: General disorders
Notes: We did not collect cause of death due to a 2-year lag between the time of death and assignment of the cause of death by the state.
Frequency: 125 affected / 666 at risk
Study: NCT02056639

Adverse event: Urinary tract infection
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 23 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 23 at risk
Study: NCT02056652

Adverse event: Bacterial vaginosis
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: BV was accessed in both groups
Frequency: 3 affected / 61 at risk

Adverse event: Bacterial vaginosis
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: BV was accessed in both groups
Frequency: 6 affected / 61 at risk
Study: NCT02056782

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 12 at risk

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Perirectal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 12 at risk

Adverse event: Renal tubular necrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 12 at risk

Adverse event: Angioedema
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 12 at risk
Study: NCT02057081

Adverse event: self-reported interpersonal violence
Serious: yes
Organ System: Social circumstances
Notes: Self-reported physical altercation with partner
Frequency: 3 affected / 136 at risk

Adverse event: medical hospitalization
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 136 at risk

Adverse event: Medical hospitalization
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 136 at risk

Adverse event: Medical hospitalization
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 136 at risk

Adverse event: psychiatric hospitalization
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 112 at risk

Adverse event: Medical hospitalization
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 112 at risk

Adverse event: Medical hospitalization
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 112 at risk

Adverse event: Medical hospitalization
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 112 at risk
Study: NCT02057575

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 29 affected / 73 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 73 at risk

Adverse event: Instillation site erythema
Serious: no
Organ System: General disorders
Frequency: 11 affected / 73 at risk

Adverse event: Instillation site pain
Serious: no
Organ System: General disorders
Frequency: 5 affected / 73 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 29 affected / 73 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 4 affected / 73 at risk

Adverse event: Instillation site erythema
Serious: no
Organ System: General disorders
Frequency: 14 affected / 73 at risk

Adverse event: Instillation site pain
Serious: no
Organ System: General disorders
Frequency: 8 affected / 73 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 27 affected / 78 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 78 at risk

Adverse event: Instillation site erythema
Serious: no
Organ System: General disorders
Frequency: 17 affected / 78 at risk

Adverse event: Instillation site pain
Serious: no
Organ System: General disorders
Frequency: 4 affected / 78 at risk

Adverse event: Ulcerative keratitis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 73 at risk

Adverse event: Large intestine perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 73 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 73 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 73 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 73 at risk

Adverse event: Instillation site erythema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 73 at risk

Adverse event: Instillation site pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 73 at risk
Study: NCT02057757

Adverse event: Aspergillus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 130 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 130 at risk

Adverse event: Pneumonia viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 130 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 130 at risk

Adverse event: Delirium
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 130 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 130 at risk

Adverse event: Vomitting
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA System Organ Class and Preferred term.
Frequency: 8 affected / 130 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: MedDRA System Organ Class and Preferred Term.
Frequency: 8 affected / 130 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA System Organ Class and Preferred Term.
Frequency: 10 affected / 130 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 127 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 127 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 127 at risk

Adverse event: Immune reconstitution inflammatory syndrome associated Kaposi's sarcoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 127 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 127 at risk

Adverse event: Vomitting
Serious: no
Organ System: Gastrointestinal disorders
Notes: MedDRA System Organ Class and Preferred term.
Frequency: 14 affected / 127 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: MedDRA System Organ Class and Preferred Term.
Frequency: 5 affected / 127 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: MedDRA System Organ Class and Preferred Term.
Frequency: 7 affected / 127 at risk
Study: NCT02058069

Adverse event: Arthrofibrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 100 at risk

Adverse event: Adhesions
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 100 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 100 at risk
Study: NCT02058095

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

Adverse event: Lightheadness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 15 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 15 at risk

Adverse event: Small intestinal obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Nasal Drainage
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 15 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 15 at risk

Adverse event: Acid Reflux
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk
Study: NCT02058563

Adverse event: Abdominal pain lower
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 454 at risk

Adverse event: Biliary colic
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 454 at risk

Adverse event: Tendon injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 454 at risk

Adverse event: Psychogenic seizure
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 454 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 53 affected / 454 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 23 affected / 454 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 13 affected / 454 at risk

Adverse event: Vaccination site pain
Serious: no
Organ System: General disorders
Frequency: 51 affected / 454 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 457 at risk

Adverse event: Pancreatitis relapsing
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 457 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 457 at risk

Adverse event: Jaw fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 457 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 457 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 457 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 52 affected / 457 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 29 affected / 457 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 23 affected / 457 at risk

Adverse event: Vaccination site pain
Serious: no
Organ System: General disorders
Frequency: 51 affected / 457 at risk