Results

Courtney Gidengil; Matthew Bidwell Goetz; Margaret Maglione; Sydne J. Newberry; Peggy Chen; Kelsey O’Hollaren; Nabeel Qureshi; Keller Scholl; Alicia Ruelaz Maher; Olamigoke Akinniranye; Tim M. Kim; Oluwafemi Jimoh; Lea Xenakis; Weilong (David) Kong; Zichun Xu; Owen Hall; Jody Larkin; Aneesa Motala; Susanne Hempel

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Gidengil C, Goetz MB, Maglione M, et al. Safety of Vaccines Used for Routine Immunization in the United States: An Update [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2021 May. (Comparative Effectiveness Review, No. 244.)

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Safety of Vaccines Used for Routine Immunization in the United States: An Update [Internet].

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Appendix CResults

This appendix provides more detail on the included studies. Note: The references in this appendix can be found in the list at the end of the main report

Results of Literature Searches

The literature searches and public posting identified a large number of relevant material.

Literature Searches

This update identified 36,076 citations. Of these, 4,303 were obtained as full text. In total, 189 studies reported in 338 publications were identified in this update.

SEADs Input

We solicited public comments for the project in two ways. The AHRQ EPC Program placed an advertisement in the FedEteral Register that described the project and requested public comment. In addition, we established a Supplemental Evidence and Data (SEADS) portal. Multiple submissions from single individuals or groups were counted as one submission. Content of submissions was assessed as pro-vaccine, neutral, or vaccine-hesitant.

A total of 67 submissions—from 14 organizations or individuals—were received through the EPC. These consisted of 11 vaccine-hesitant groups (accounting for 63 of 67 of the submissions) and three submissions that were vaccine neutral.

A total of 61 submissions were received through the SEADS portal, representing18 organizations or individuals. These consisted of 15 vaccine-hesitant submitters and three neutral.

Description of Included Studies

This update documents studies published since the last AHRQ report on the topic²⁸ and summarizes results from the prior report where appropriate. All included studies used participant samples where all or at least more than 50 percent were receiving recommended vaccines; none of the studies were exclusively in participants where the vaccine was counter-indicated for the participant group. We only included currently available vaccines recommended in the United States and excluded other vaccines. As described throughout, the included studies used a range of study designs and methods to collect safety data. The adverse events assessed for the individual vaccines are shown in the next table.

Table C.1Assessed adverse events in vaccine studies in adults

Vaccine	Assessed Adverse Events
Influenza RIV	Abdominal hernia repair Abdominal pain Abdominal wall neoplasm Abortion spontaneous Abscess intestinal Acute myocardial infarction Acute respiratory failure Alcohol detoxification Anaemia Angina pectoris Angina unstable Anxiety Aortic aneurysm Aortic aneurysm rupture Aortic dissection Appendicitis Arm amputation Arrhythmia Arteriosclerosis Arthralgia Arthritis Aspiration Asthenia Atrial fibrillation Atrial flutter Back pain B-cell lymphoma Benign prostatic hyperplasia Bladder cancer Bladder neoplasm Bladder outlet obstruction Breast cancer Bronchitis Calculus ureteric Cardiac arrest Cardiac disorders Cardiac failure Cardiac failure congestive Cardiac tamponade Cardiogenic shock Cardio-respiratory arrest Cardiovascular disorder Cellulitis Cerebral haemorrhage Cerebrovascular accident Cervical vertebral fracture Chest pain Cholecystitis Cholelithiasis Chronic obstructive pulmonary disease Circulatory collapse Colitis ischaemic Colorectal cancer Colorectal cancer recurrent Convulsion Coronary artery disease Coronary artery insufficiency Coronary artery stenosis Coronary artery thrombosis Cough Craniocerebral injury Crying Cyclic vomiting syndrome Cystocele Death Decreased appetite Dehydration Device related infection Diabetes mellitus inadequate control Diabetic ketoacidosis Diverticulitis Diverticulum Diverticulum intestinal haemorrhagic Drug detoxification Drug withdrawal syndrome Dysphagia Embolic stroke Encephalopathy Endocarditis staphylococcal Epistaxis Erysipelas Eye abscess Failure to thrive Fatigue Food poisoning Gangrene Gastric bypass Gastric ulcer Gastroenteritis viral Gastrointestinal haemorrhage Gout Haematocrit decreased Haemorrhage Haemorrhagic stroke Haemorrhoids Head injury Headache Hepatic cancer Hepatic cirrhosis Hepatic haemorrhage Hepatitis alcoholic Hepatobiliary disorders Hernia obstructive Hernia repair Hiatus hernia Hip arthroplasty Hip fracture Hyperglycaemia Hyperhidrosis Hypertensive crisis Hypoglycaemia Hyponatraemia Hypotension Ileus Influenza Influenza like illness Inguinal hernia Inguinal hernia repair Injection site erythema Injection site pain Injection site swelling International normalised ratio increased Intervertebral disc compression Intervertebral disc degeneration Intervertebral disc protrusion Intestinal obstruction Intestinal perforation Intestinal resection Invasive ductal breast carcinoma Irritability Ischaemic cardiomyopathy Joint surgery Knee arthroplasty Lactic acidosis Lacunar infarction Leukocytosis Loss of consciousness Lower limb fracture Lumbar radiculopathy Lumbar spinal stenosis Lung Infection Malaise Menorrhagia Metabolic encephalopathy Metastases to liver Microcytic anaemia Mortality Muscular weakness Musculoskeletal pain Myalgia Myelomalacia Myocardial infarction Nasophayngitis Neck pain Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nervous system disorders Non-cardiac chest pain Obesity Oedema peripheral Oesophageal carcinoma Oropharyngeal pain Osteoarthritis Osteomyelitis Osteomyelitis acute Osteomyelitis chronic Otitis media Ovarian cyst Overdose Pain Pain in extremity Pancreatic carcinoma metastatic Pancreatitis Peripheral arterial occlusive disease Periumbilical abcess Pleural effusion Pneumonia Pneumonia bacterial Procedural pain Productive cough Prostate cancer Pulmonary embolism Pyelonephritis Pyrexia Rash Renal cancer Renal failure acute Renal necrosis Respiratory failure Rhabdomyolysis Rhabdomyoma Road traffic accident Rotator cuff repair Rotator cuff syndrome Salmonellosis Sick sinus syndrome Sinus headache Sinusitis Small intestinal obstruction Somnolence Spinal column stenosis Spinal compression fracture Squamous cell carcinoma of lung Stab wound Subarachnoid haemorrhage Suicidal ideation Supraventricular tachycardia Syncope Tendon rupture Tenosynovitis stenosans Testis cancer Thalamic infarction Thrombocytosis Thrombosis Thyroid cancer Thyroid neoplasm Tibia fracture Toxicity to various agents Transient ischaemic attack Transitional cell carcinoma Troponin increased Upper gastrointestinal haemorrhage Upper limb fracture Upper respiratory tract infection Urinary retention Urinary tract infection Urinary tract infection fungal Urosepsis Uterine disorder Vertigo Viral upper respiratory tract infection Volvulus Vomiting Wound complication
Hepatitis B (HepB; Engerix-B, Recombivax HB, HELISAV-B)	Abdominal hernia Abdominal pain Abortion spontaneous Abscess limb Abscess neck Accident Accidental overdose Acquired central nervous system demyelinating syndromes (CNS ADS) Acute coronary syndrome Acute disseminated encephalomyelitis (ADEM) Acute myocardial infarction Acute prerenal failure Acute respiratory distress syndrome Acute respiratory failure Acute sinusitis Adenocarcinoma of colon Adenomyosis Alcohol poisoning Anaemia Anaemia vitamin b12 deficiency Angina pectoris Angina unstable Ankle fracture Aortic aneurysm Aortic stenosis Appendicitis Appendicitis perforated Appendix disorder Arterial injury Arthralgia Arthritis bacterial Asthma Atrial fibrillation Atrial flutter Atrial septal defect Back pain Bacteraemia Barrett’s oesophagus Benign intracranial hypertension Bile duct stone Bipolar disorder Bladder disorder Bradycardia Brain neoplasm Brain neoplasm benign Breast cancer Bronchial hyperreactivity Bronchitis Bursitis Calculus ureteric Cardiac arrest Cardiac failure Cardiac failure acute Cardiac failure congestive Cardiac ventricular thrombosis Cardiogenic shock Cardiomyopathy Cardio-respiratory arrest Carotid artery stenosis Carotid sinus syndrome Cauda equina syndrome Cavernous sinus thrombosis Cellulitis Cellulitis of male external genital organ Cellulitis orbital Cerebrovascular accident Cervical myelopathy Cervical vertebral fracture Cervix carcinoma Chest pain Cholangiocarcinoma Cholecystitis Cholecystitis acute Cholecystitis chronic Cholecystitis infective Cholelithiasis Chronic obstructive pulmonary disease Clear cell renal cell carcinoma Clinically isolated syndrome (CIS) Clostridium difficile colitis Colitis Colitis ulcerative Colon adenoma Colon cancer stage iv Complex partial seizures Concussion Confusional state Constipation Contusion Convulsion Coronary artery disease Coronary artery occlusion Coronary artery stenosis Costochondritis Cough Craniocerebral injury Cyclic vomiting syndrome Cystocele Death Deep vein thrombosis Dehydration Delayed recovery from anaesthesia Delirium Depression Depression suicidal Device failure Device related infection Diabetes mellitus inadequate control Diabetic foot Diabetic foot infection Diabetic ketoacidosis Diaphragmatic paralysis Diaphragmatic rupture Diarrhoea Diverticular perforation Diverticulitis Diverticulum intestinal haemorrhagic Dizziness Drug withdrawal syndrome Ductal adenocarcinoma of pancreas Duodenal ulcer haemorrhage Dysfunctional uterine bleeding Dyslipidaemia Dyspnoea Ebstein’s anomaly Electrophoresis protein abnormal Embolic stroke Endocrine disorders Endometrial cancer Endometriosis Erosive oesophagitis Erysipelas Facial bones fracture Fall Fatigue Femoral neck fracture Femur fracture Fever Fibula fracture Flank pain Foetal growth restriction Foetal heart rate abnormal Foot fracture Forearm fracture Gastric haemorrhage Gastric ulcer Gastric ulcer haemorrhage Gastritis Gastritis alcoholic Gastritis alcoholic haemorrhagic Gastritis haemorrhagic Gastroenteritis Gastroenteritis salmonella Gastroenteritis viral Gastrointestinal anastomotic leak Gastrointestinal haemorrhage Gastrooesophageal reflux disease Gestational diabetes Groin abscess Gun shot wound Haematemesis Haemorrhagic ovarian cyst Haemorrhagic stroke Haemothorax Hand fracture Head injury Headache Hepatic cirrhosis Hepatic encephalopathy Hepatitis c Hiccups Hidradenitis Hip fracture Hodgkin’s disease Humerus fracture Hyperglycaemia Hypersensitivity Hypertension Hypertensive crisis Hypertensive heart disease Hypoaesthesia Hypoglycaemia Hypokalaemia Hyponatraemia Hypotension Hypothyroidism Hypoxia Hypoxic-ischaemic encephalopathy Ileus Ileus paralytic Impaired gastric emptying Inappropriate antidiuretic hormone secretion Infections and infestations Infectious colitis Inflammatory carcinoma of the breast Influenza Inguinal hernia Injection site pain Intentional overdose International normalised ratio increased Intervertebral disc degeneration Intervertebral disc protrusion Intestinal obstruction Intraductal papillary mucinous neoplasm Intraductal proliferative breast lesion Invasive ductal breast carcinoma Investigations Ischaemic hepatitis Ischaemic stroke Jaw fracture Joint injury Laceration Lacunar infarction Large intestine perforation Latent tuberculosis Leukocytosis Lobar pneumonia Localised infection Loose body in joint Lower gastrointestinal haemorrhage Lower limb fracture Lumbar radiculopathy Lumbar spinal stenosis Lumbar vertebral fracture Lung adenocarcinoma Lung cancer metastatic Lung infiltration Major depression Malaise Malignant melanoma Meningitis Meniscus injury Menstruation irregular Mental status changes Metabolism and nutrition disorders Metastatic renal cell carcinoma Microcytic anaemia Migraine Multiple sclerosis (MS) Muscle strain Muscular weakness Musculoskeletal chest pain Musculoskeletal pain Myalgia Mycobacterium avium complex infection Myocardial infarction Myocardial ischaemia Myositis Nasal polyps Nasopharyngitis Neck pain Nephrolithiasis Nervous system disorders Neuropathy peripheral Non-cardiac chest pain Non-small cell lung cancer metastatic Oesophageal adenocarcinoma Oesophageal spasm Oesophagitis Oligohydramnios Osteoarthritis Osteomyelitis Otitis media bacterial Ovarian cancer stage iii Ovarian germ cell teratoma Overdose Pain in extremity Pancreatic carcinoma Pancreatic carcinoma metastatic Pancreatitis Pancreatitis acute Papillary thyroid cancer Patella fracture Pelvic neoplasm Periorbital cellulitis Peripheral nerve injury Peripheral vascular disorder Perirectal abscess Pituitary-dependent cushing’s syndrome Placenta praevia Plasma cell myeloma Pleural effusion Pleuritic pain Pneumonia Pneumonia aspiration Pneumonia escherichia Pneumonia staphylococcal Pneumothorax Post procedural haematoma Post procedural infection Postmenopausal haemorrhage Postoperative fever Postoperative ileus Postoperative wound infection Prerenal failure Procedural intestinal perforation Procedural pain Prostate cancer Prostate cancer stage ii Prostatitis Psychiatric disorders Pulmonary embolism Pulmonary oedema Pulseless electrical activity Pyelonephritis Pyelonephritis acute Radial nerve palsy Rectal adenocarcinoma Rectal haemorrhage Rectal prolapse Redness Renal failure Renal failure acute Renal failure chronic Respiratory arrest Respiratory failure Rhabdomyolysis Rib fracture Rotator cuff syndrome Scapula fracture Schizoaffective disorder Schizophrenia Sepsis Seroma Sickle cell anaemia with crisis Sinusitis Small cell lung cancer metastatic Small intestinal obstruction Social circumstances Spinal column stenosis Spinal fracture Spinal osteoarthritis Splenic abscess Spondylitic myelopathy Spondylolisthesis Squamous cell carcinoma of the cervix Squamous cell carcinoma of the oral cavity Stab wound Staphylococcal abscess Staphylococcal infection Staphylococcal osteomyelitis Subarachnoid haemorrhage Substance-induced psychotic disorder Suicidal ideation Suicide attempt Supraventricular tachycardia Swelling Syncope Thalamic infarction Thermal burn Thrombophlebitis superficial Thrombotic stroke Thyroid mass Tibia fracture Tibia fracture Toxicity to various agents Transient global amnesia Transient ischaemic attack Traumatic haemothorax Tubulointerstitial nephritis Type 2 diabetes mellitus Upper gastrointestinal haemorrhage Upper respiratory tract infection Urinary retention Urinary retention postoperative Urinary tract infection Urinary tract infection enterococcal Urosepsis Uterine leiomyoma Vaginal haemorrhage Varices oesophageal Vascular disorders Ventricular fibrillation Ventricular tachycardia Vertebral foraminal stenosis Vertigo Vertigo positional Victim of homicide Viral sepsis Vitiligo Water intoxication Wound infection Wound infection staphylococcal Wrist fracture
Hepatitis A and B (Twinrix)	N/A
Haemophilus influenzae type b (Hib; PedvaxHIB, ActHIB, Hiberix)	N/A
Human papillomavirus (HPV9; Gardasil 9)	N/A
Inactivated influenza (IIV; Afluria Quadrivalent, Flucelvax Quadrivalent, Fluarix Quadrivalent, Fluzone Quadrivalent, Fluad)	Abdominal hernia Abdominal pain Abdominal pain upper Abdominal wall hematoma Abortion spontaneous Abscess intestinal Abscess limb Accelerated hypertension Acute abdomen Acute coronary syndrome Acute kidney injury Acute leukaemia Acute myeloid leukaemia Acute myeloid leukemia and worsening of diabetes Acute Myocardial Infarction Acute myocardial rejection Acute respiratory failure Adenocarcinoma Adenocarcinoma of colon Alcoholism Ammonia increased Amyotrophic lateral sclerosis Anaemia Anaemia postoperative Anaesthetic Complication Anaphylactic reaction Anemia Aneurysm ruptured Angina pectoris Angina unstable Angioedema Animal bite Ankle Fracture Aortic aneurysm Aortic dissection Aortic Stenosis Appendicitis Appetite lost Arrhythmia Arteriosclerosis Arteriosclerosis coronary artery Arthalgia (prespecified) Arthralgia (prespecified) Arthritis Arthritis bacterial Arthritis infective Arthropathy Ascites Asthenia Asthma Asthmatic crisis Atelectasis Atrial Fibrillation Atrial tachycardia Atrioventricular Block Complete Atrioventricular block second degree Atypical pneumonia Azotemia Back injury Back Pain Bacteraemia Basal cell carcinoma B-cell lymphoma Bell’s palsy (prespecified) Benign prostatic hyperplasia Bile duct stone Bipolar disorder Bladder adenocarcinoma stage unspecified Bladder Cancer Bladder transitional cell carcinoma Blindness unilateral Bone Contusion Bradycardia Brain herniation Brain Neoplasm Brain neoplasm malignant Breast Cancer Breast cancer stage II Bronchiolitis Bronchitis Bronchospasm Bundle branch block left Calculus bladder Calculus ureteric Cardiac arrest Cardiac disorder Cardiac failure Cardiac failure acute Cardiac failure congestive Cardiogenic shock Cardiopulmonary failure Cardio-respiratory arrest Carotid artery disease Carotid Artery Occlusion Carotid Artery Stenosis Cellulitis Cellulitis staphylococcal Central nervous system infection Cerebellar infraction Cerebral haemorrhage Cerebral infraction Cerebral ischaemia Cerebrospinal Fluid Leakage Cerebrovascular Accident Cerebrovascular disorder Cervical myelopathy Cervical spinal stenosis Cervicobrachial syndrome Cervix carcinoma Chest discomfort Chest pain Chills (prespecified) Cholangiocarcinoma Cholangitis Cholangitis acute Cholecystitis Cholecystitis Acute Cholecystitis chronic Cholelithiasis Chronic hepatic failure Chronic myeloid leukaemia Chronic Obstructive Pulmonary Disease Clavicle fracture Colitis Colon adenoma Colon cancer Coma hepatic Concussion Confusional state Constipation Convulsion Corneal degeneration Coronary artery disease Coronary artery restenosis Costochondritis Cough Craniocerebral injury Crying abnormal Cystitis Cystocele Death Decreased appetite Deep Vein Thrombosis Dehydration Dementia alzheimer’s type Dementia with lewy bodies Depressed level of consciousness Depression Device related infection Diabetes Mellitus Diabetes mellitus inadequate control Diabetic foot Diabetic ketoacidosis Diarrhea (prespecified) Diplopia Disseminated intravascular coagulation Diverticular perforation Diverticulitis Diverticulum Diverticulum intestinal Diverticulum Intestinal Haemorrhagic Dizziness Dressler’s syndrome Drowsiness Drug hypersensitivity Duodenal ulcer perforation Dyspepsia Dysphagia Dyspnea Ecchymosis Electrolyte imbalance Embolic stroke encephalitis/myelitis (prespecified) Encephalopathy Endocarditis Endometrial adenocarcinoma Endometrial cancer Endometriosis Enteritis Erosive oesophagitis Erysipelas Erythema (prespecified) Escherichia sepsis Esophageal injury Eye disor Facial bones fracture Facial Paralysis Fall Fatigue (prespecified) Femoral hernia,obstructive Femoral neck fracture Femur Fracture Fever (prespecified) Foot fracture Forearm Fracture Fracture displacement Gait disturbance Gastric adenoma Gastric cancer Gastric ulcer Gastric ulcer haemorrhage Gastric ulcer perforation Gastritis Gastroenteritis Gastroenteritis viral Gastrointestinal adverse event(s) (prespecified) Gastrointestinal disorder Gastrointestinal Haemorrhage Gastrointestinal intolerance Gastrointestinal mucosal disorder Gastrointestinal perforation Gastrointestinal stromal tumor Gastrointestinal symptoms Gastrointestinal Ulcer Haemorrhage Gastrooesophageal reflux disease Generalised tonic-clonic seizure Gouty arthritis Granulomatosis with polyangiitis Groin abscess Groin Pain Guillain-barre syndrome Guillain-Barre syndrome (prespecified) Haematochezia Haemorrhage Haemorrhage intracranial Haemorrhagic Anaemia Head injury Headache (prespecified) Headcahe Hemiplegia Hemorrhage intracranial Hepatic cirrhosis Hepatic failure Hepatic neoplasm malignant Hepatobiliary disor Hernia obstructive Herpes zoster Hiatus hernia Hip fracture Histiocytosis haematophagic Hospitalization Humerus Fracture Hydrocele Hydronephrosis Hyperglycaemia Hypertension Hypertensive crisis Hypertensive heart disease Hypertrophic cardiomyopathy Hypoaesthesia Hypocalcaemia Hypoglycaemia Hypokalaemia Hypomagnesaemia Hyponatraemia Hypotension Hypovolaemia Hypoxia Idiopathic Thrombocytopenic coagulation Ileus Ileus paralytic Immune system disor Implantable defibrillator insertion Incision site infection Incisional Hernia Induration Infected skin ulcer Infections and infestat Infectious peritonitis Influenza Influenza symptoms Inguinal Hernia Inguinal hernia, obstructive Injection Site Erythema (prespecified) Injection site induration Injection Site Pain (prespecified) Injection Site Swelling (prespecified) Injection site tenderness Injection-site hemorrhage Interstitial lung disease Intervertebral disc degeneration Intervertebral disc disorder Intervertebral Disc Protrusion Intestinal infarction Intestinal obstruction Intestinal perforation Intracranial aneurysm Invasive Ductal Breast Carcinoma Investigati Investigatio Investigations Iron deficiency anaemia Irritability Irritable bowel syndrome Ischaemic Cerebral Infarction Ischemic stroke Jaundice Jaw fracture Joint dislocation Joint pain Joint pain at other location than injection site Joint swelling Laceration Large intestinal obstruction Large intestine perforation Laryngitis Leptospirosis Leukocytosis Ligament rupture Lobar pneumonia Loss of appetite (prespecified) Loss of consciousness Lower gastrointestinal haemorrhage Lower limb fracture Lower respiratory tract infection Lumbar Spinal Stenosis Lumbar vertebral fracture Lung adenocarcinoma Lung cancer metastatic Lung carcinoma cell type unspecified stage IV Lung neoplasm malignant Lung squamous cell carcinoma stage unspecified Malaise Malaise (prespecified) Malaise (prespecified) Malignant Melanoma Malnutrition Meningioma Meningitis aseptic Meningitis viral Mental Status Changes Metabolic encephalopathy Metastases to lung Metastatic neoplasm Mitral valve incompetence Mortality Multi-organ failure Multiple injuries Muscle aches Muscle haemorrhage Muscular weakness Musculoskeletal chest pain Myalgia (prespecified) Myocardial infarction Myocardial Ischemia Nasopharyngitis Nausea (prespecified) Neoplasm Malignant Nephrolithiasis Nephropathy Nerve injury Nervous system disorder Nodal arrythmia Nodal rhythm Non-cardiac chest pain Non-small cell lung cancer Obstructive uropathy Oesophageal carcinoma Oesophagitis optic neuritis (prespecified) Oropharyngeal pain Osteoarthritis Osteomyelitis Ovarian adenoma Ovarian cancer Ovarian cancer stage IV Overdose Oxygen saturation decreased Pain (prespecified) Pain in extremity Pancreatic Carcinoma Pancreatic mass Pancreatic neoplasm Pancreatitis Pancreatitis acute Parainfluenzae Viral Laryngotracheobronchitis Parathyroid tumor benign Patella fracture Pelvic fracture Pelvic inflammatory disease Peptic ulcer Peptic ulcer perforation Pericarditis Peripheral artery aneurysm Peripheral Vascular Disorder Perirenal haematoma Peritonsillar abscess Pituitary tumour benign Pleural effusion Pleurisy Pneumonia Pneumonia aspiration Pneumonia bacterial Pneumonia legionella Pneumonia viral Pneumoperitonium Portal hypertension Post procedural haemorrhage Posterior reversible encephalopathy syndrome Postoperative adhesion Postoperative ileus Postpericardiotomy Syndrome Postprocedural hematuria Presyncope Procedural dizziness Prolymphocytic leukaemia Prostate Cancer Prostatomegaly Prostrate cancer Pruritus Psychiatric disorders Pulmonary edema Pulmonary Embolism Pulmonary hypertension Pulmonary mass Pulmonary Tuberculosis Pyelonephritis Pyelonephritis acute Pyrexia Radiculopathy Radius fracture Rash Rectal cancer Rectal haemorrhage Redness (prespecified) Renal and urinary disorders Renal cell carcinoma Renal Failure Renal Failure acute Renal failure chronic Renal impairment Renal mass Respiratory arrest Respiratory Failure Respiratory syncytial virus infection Respiratory Tract Infection Retina detachment Retinal neovascularisation Rhabdomyolysis Rhinorrhoea Rib Fracture Road Traffic Accident Rotator cuff syndrome Ruptured cerebral aneurysm Sarcoma Scapula fracture Seizure Sepsis Septic Shock Seroma Severe pain Shivering (prespecified) Sick sinus syndrome Sideroblastic anaemia Sinus Bradycardia Sinus node dysfunction Sinus Tachycardia Sinusitis Skin abrasion Skin cancer Skin Ulcer Sleep apnoea syndrome Small cell lung cancer stage unspecified Small Fibre Neuropathy Small intestinal obstruction Spasmodic dysphonia Spinal column stenosis Spinal Compression Fracture Spinal cord injury Spinal Osteoarthritis Spondylolisthesis Squamous cell carcinoma Squamous cell carcinoma of the cervix Stab wound Staphylococcal Infection Stevens-Johnson syndrome (prespecified) Strangulated hernia Streptococcal Infection Streptococcal sepsis Stress Cardiomyopathy Stroke in evolution Subarachnoid hemorrhage Subdural haematoma Subjective fever Sudden Death Swelling (prespecified) Syncope Tenderness (prespecified) Tendon Rupture Tetanus Thalamic infarction Thoracic vertebral fracture Thrombocytopenia Thrombosis Thyroid cancer Tibia fracture Tooth abscess toxic epidermal necrolysis (prespecified) Tracheobronchitis Transient ischemic attack Transitional cell carcinoma Traumatic liver injury Troponin Increased Tuberculosis Type 2 Diabetes Mellitus Unspecified gastrointestinal bleeding Upper airway obstruction Upper gastrointestinal haemorrhage Upper limb fracture Upper respiratory tract infection Ureteric stenosis Urinary incontinence Urinary Retention Urinary tract infection Urosepsis Uterine Leiomyoma Uterovaginal prolapse Varicose ulceration Vascular disorder Vascular Stent Thrombosis Venous thrombosis limb Ventricular arrhythmia Ventricular extrasystoles Ventricular fibrillation Ventricular Tachycardia Vertebrobasilar insufficiency Vertigo Vestibular disorder VIIth nerve paralysis Viral Infection Viral pericarditis Viterous hemorrhage Volvulus Vomiting (prespecified) Wound abscess Wound dehiscence Wrist fracture
Live attenuated influenza (LAIV; FluMist Quadrivalent)	N/A
Measles, mumps, rubella (MMR; M-M-R II)	N/A
Meningococcal, Quadrivalent [MenACWY-D (Menactra), MenACWY-CRM (Menveo), MenACWY-TT (MenQuadfi)]	Acute Myocardial Infarction Acute tonsillitis Arthralgia Atrial Fibrillation Benign Prostatic Hyperplasia Bile Duct Stone Biliary Colic Chills Colitis Ischaemic Completed suicide Coronary Artery Disease Cough Deep Vein Thrombosis Depression Suicidal Device Failure Device Related Infection Dizziness Erythema Escherichia Sepsis Fatigue Foot Deformity Headache Induration Influenza Influenza-like illness Injection Site Erythema Injection Site Pain Injury Intervertebral disc protrusion Invasive Lobular Breast Carcinoma Ischaemic Stroke Joint Contracture Localised Infection Lung Adenocarcinoma Lung Cancer Metastatic Malaise Mortality Multiple Fractures Muscle Strain Myalgia Myocardial Infarction Nasopharyngitis Nausea Non-Cardiac Chest Pain Oropharyngeal pain Osteoarthritis Osteomyelitis Pain Pain in an extremity Pancreatitis Acute Pancreatitis Relapsing Pelvic Fracture Peripheral Vascular Disorder Pneumonia Prostate Cancer Pruritus Psychiatric disorders Pyrexia Renal cancer Sepsis Skin Ulcer Spinal Column Injury Tooth disorder Transient Ischaemic Attack Vaccination site pain Vascular disorders Vertigo
Meningococcal B [MenB; MenB-4C (Bexsero), MenB-FHbp (Trumenba)]	N/A
Pneumococcal conjugate (PCV13, Prevnar 13)	Abdominal abscess Abdominal hernia Abdominal pain Abdominal pain lower Abdominal pain upper Abscess oral Accidental death Accidental overdose Acquired phimosis Actinic keratosis Acute coronary syndrome Acute disseminated encephalomyelitis Acute kidney injury Acute myocardial infarction Acute pericarditis Adenocarcinoma of colon Adverse events Ageusia Aggravated generalized joint pain Aggravated generalized muscle pain Allergic Reaction Alveolitis allergic Anaemia Anaemia postoperative Anaphylactic reaction Anaphylactic shock Anaphylaxis Angina pectoris Angina unstable Angioedema Ankle fracture Anxiety Aortic aneurysm Aortic aneurysm rupture Aortic arteriosclerosis Aortic valve stenosis Aphonia Appendicitis Arrhythmia Arthralgia Arthritis Asphyxia Asthenia Asthma Atrial fibrillation Atrial flutter Atrial tachycardia Atrioventricular block Atrioventricular block complete Atrioventricular block first degree Atrioventricular block second degree Back pain Balance disorder Basal cell carcinoma Bell’s palsy Benign prostatic hyperplasia Bile duct adenocarcinoma Bile duct stone Bipolar disorder Bladder adenocarcinoma stage unspecified Bladder cancer Bladder transitional cell carcinoma Blood blister Blood pressure increased Bone contusion Bone cyst Bone loss Bowen’s disease Bradycardia Brain contusion Breast cancer Bronchial carcinoma Bronchiolitis Bronchitis Bronchitis chronic Bursitis Calculus bladder Cardiac arrest Cardiac asthma Cardiac disorders Cardiac failure Cardiac failure congestive Cardiac valve replacement complication Cardiogenic shock Cardiomyopathy Cardiomyopathy or heart failure Cardio-respiratory arrest Cardiovascular disease or cancer Carotid artery stenosis Cataract Cellulitis Cellulitis and infection Cerebral haemorrhage Cerebral infarction Cerebral ischaemia Cerebrovascular accident Change of bowel habit Chemical burn of skin Chemical burns of eye Chest pain Chills Cholangitis Cholangitis suppurative Cholecystitis Cholecystitis acute Cholelithiasis Chronic obstructive pulmonary disease Chronic sinusitis Circulatory collapse Clear cell renal cell carcinoma Colitis Colon cancer Colon cancer metastatic Colon neoplasm Colorectal cancer metastatic Concussion Conjunctivitis Conjunctivitis allergic Constipation Contusion Convulsion Corneal graft rejection Coronary artery disease Coronary artery dissection Coronary artery stenosis Cough Cyst Cystitis Cystitis noninfective Death Decreased appetite Deep vein thrombosis Delirium Depression Dermatitis allergic Dermatitis contact Device breakage Device dislocation Device occlusion Device related infection Diarrhea Discoloration Diverticulitis Diverticulum intestinal haemorrhagic Dizziness Drug hypersensitivity Dry skin Duodenal perforation Duodenal ulcer Dyspepsia Dyspnoea Dyspnoea exertional Ecchymosis Eczema Electrocardiogram T wave abnormal Electrolyte imbalance Endometrial adenocarcinoma Endometrial cancer Enteritis infectious Enterococcus faecalis Epicondylitis Epilepsy Epistaxis Eructation Erysipelas Erythema multiforme Eye disorders Face injury Facial bones fracture Fall Fatigue Female genital tract fistula Femoral neck fracture Femur fracture Fever Fibromyalgia Finger deformity Flank pain Folliculitis Food allergy Food poisoning Foot fracture Forearm fracture Foreign body aspiration Fracture Fungal infection Fungal skin infection Gangrene Gastric cancer Gastric perforation Gastritis Gastroenteritis Gastrointestinal haemorrhage Gastrointestinal viral infection Gastrooesophageal reflux disease General disorders Gingivitis Glioblastoma Glioma Gout Groin infection Guillain-Barre Syndrome Haematoma Haematuria Haemorrhoids Hand fracture Head injury Headache Hemiparesis Hepatic adenoma Hepatic encephalopathy Hepatic enzyme increased Hepatobiliary disorder Hernia obstructive Herpes zoster Hiatus hernia Hip fracture Humerus fracture Hydrothorax Hypercalcaemia Hyperhidrosis Hypertension Hyperventilation Hypoglycaemia Hypopharyngeal cancer Hypotension Idiopathic thrombocytopenic purpura Ileus Ill-defined disorder Implant site fibrosis Incisional hernia Inclusion body myositis Infections and infestat Infective exacerbation of chronic obstructive airways disease Influenza Inguinal hernia, obstructive Injection site erythema Injection site exfoliation Injection site haematoma Injection site induration Injection site pain Injection site pruritus Injection site rash Injection site reaction Injection site swelling Injury Intermittent claudication International normalised ratio decreased Intervertebral disc protrusion Intestinal obstruction Intestinal perforation Investigations Iron deficiency anaemia Ischaemic stroke Itch on a leg Itching Joint dislocation Joint injury Joint range of motion decreased Joint stiffness Joint swelling Keratoacanthoma Kidney contusion Lactic acidosis Large intestinal stenosis Laryngeal cancer Left ventricular failure Leukaemia Ligament injury Ligament sprain Limb injury Limitation of arm move Limitation of arm movement Limitation of arm movement of the injected arm Localised infection Localized swelling Loose tooth Loss of consciousness Lower limb fracture Lower respiratory tract infection Lumbar spinal stenosis Lumbar vertebral fracture Lung adenocarcinoma metastatic Lung disorder Lung infiltration Lung neoplasm malignant Lymphadenopathy Macular fibrosis Malaise Malignant hypertension Malignant melanoma Malignant neoplasm of renal pelvis Medical device complication Melaena Melanoma recurrent Meningitis Mental status changes postoperative Mesothelioma Metabolism and nutrition disor Metastasis Metastatic gastric cancer Metastatic renal cell carcinoma Micturition urgency Mild soreness Mitral valve incompetence Mobility Loss Mortality Multiple injuries Muscle aches Muscle spasms Muscle strain Muscular weakness Musculoskeletal chest pain Musculoskeletal discomfort Musculoskeletal disorder Musculoskeletal pain Musculoskeletal stiffness Myalgia Myelodysplastic syndrome Myocardial infarction Myocardial ischaemia Myositis Nasopharyngitis Nausea Neoplasm prostate Nephrolithiasis Nerve compression Nervous system disor Neuropathy peripheral New generalized joint pain New generalized muscle pain New or aggravated muscle of joint pina Non-cardiac chest pain Non-small cell lung cancer Ocular hyperaemia Oedema peripheral Oesophageal adenocarcinoma Oesophageal carcinoma recurrent Oral herpes Oral temperature Oropharyngeal pain Osteitis Osteoarthritis Osteomyelitis Osteopenia Osteoporosis Otitis externa Otitis media Ovarian cancer Ovarian cyst Pain Pain in extremity Pain in jaw Pain killers Pain of skin Palpitations Pancreatic carcinoma (not prespecified and not vaccine related) Pancreatitis Pancreatitis acute Pancytopenia Paraesthesia Pelvic fracture Pelvic haematoma Pelvic pain Pericarditis Periorbital contusion Peripheral arterial occlusive disease Peripheral coldness Peripheral nerve lesion Peripheral swelling Periprosthetic fracture Peritonitis Peritonsillar abscess Peroneal nerve palsy Plantar fasciitis Plasma cell myeloma Pleural effusion Pneumonia Pneumonia legionella Pneumonia pneumococcal Pneumothorax Polymyalgia rheumatica Post laminectomy syndrome Presyncope Procedural haemorrhage Procedural intestinal perforation Procedural pain Productive cough Prostate cancer Prostate cancer metastatic Prostate cancer recurrent Prostatitis Pruritus Pruritus generalised Psychiatric disorders Psychotic disorder Pulmonary embolism Pulmonary hypertension Pulmonary pain Pyrexia Radicular pain Radiculitis lumbosacral Radius fracture Rash Rash erythematous Rectal cancer Rectal haemorrhage Rectal prolapse Redness Renal and urinary disor Renal cancer Renal cancer recurrent Renal cell carcinoma Renal impairment Respiratory tract infection Retinal artery occlusion Retinal detachment Rhinalgia Rhinorrhoea Rib fracture Rotator cuff syndrome Sciatica Seasonal allergy Sepsis Serious adverse events Sick sinus syndrome Silent myocardial infarction Sinus bradycardia Sinusitis Skeletal injury Skin papilloma Skin ulcer Sleep apnoea syndrome Small cell lung cancer Sneezing Splinter Spondylolisthesis Squamous cell carcinoma of skin Staphylococcal bacteraemia Staphylococcal infection Stomach pain Subarachnoid haemorrhage Subdural haematoma Subileus Sudden cardiac death Suicidal ideation Supraventricular tachycardia Surgical failure Swelling Syncope Synovial cyst Tachycardia Temperature Temporal arteritis Tenderness Tenderness in an arm Tendon injury Tendon rupture Tendonitis Testicular pain Thermal burn Thrombocytopenia I Thrombocytopenia II Thrombophlebitis Tinea barbae Tonsil cancer Tooth abscess Tooth infection Toothache Transient global amnesia Transient ischaemic attack Transitional cell carcinoma Traumatic haemorrhage Trigeminal neuralgia Tuberculosis Type 2 diabetes mellitus Ulna fracture Umbilical hernia Upper gastrointestinal haemorrhage Upper respiratory tract infection Upper-airway cough syndrome Ureteric stenosis Urethral stenosis Urinary retention Urinary retention postoperative Urinary tract infection Urine odour abnormal Urosepsis Urticaria Vaginal prolapse Varices oesophageal Vascular graft occlusion Ventricular tachycardia Vertigo Vessel puncture site haematoma Vestibular neuronitis Viral infection Viral upper respiratory tract infection Vitreous floaters Vomiting Weight decreased Wound Wound dehiscence Wound infection Wrist fracture
Pneumococcal polysaccharide vaccine (PPSV23; Pneumovax)	Acute kidney injury Acute myocardial infarction Anaemia Angina pectoris Arrhythmia Arthralgia Asthma Benign prostatic hyperplasia Calcinosis Cardiac failure Cardio-respiratory arrest Carotid artery stenosis Cerebral thrombosis Chest pain Chills Chronic obstructive pulmonary disease Colon cancer metastatic Coronary artery stenosis Coronary care unit admission Death Depression Diabetes mellitus inadequate control Erysipelas Erythema Fatigue Fever Gastrointestinal disorder Gastrointestinal infection Generalized joint pain Generalized muscle pain Headache Hospital admission Hyperhidrosis Hyperkalaemia Hypertension Influenza-like illness Intensive care unit admission Intestinal ischaemia Intestinal malrotation Ischemic heart disease Ischemic stroke Limitation of arm movement Lower respiratory tract infection Lung infection Major swelling at the injection site (elbow joint to shoulder joint) Malaise Moderate swelling at the injections site Muscle aches Myalgia Myocardial infarction Osteoarthritis Other non-specified infection Other symptoms Pain Pain at injection site Pneumonia Pneumonia aspiration Psychiatric disorders Rash Redness Redness at injection site Renal cancer stage ii Shingles Skin infection Squamous cell carcinoma of the oral cavity Swelling Tenderness Tuberculosis Upper respiratory tract infection Urinary tract infection Wrist fracture
Tetanus, diphtheria, & acellular pertussis (Tdap, Adecel, Boostrix)	Abdominal pain Abortion spontaneous Crohn’s disease Fever (prespecified) Headache (prespecified) Infectious mononucleosis Injection site erythema (prespecified) Injection site pain (prespecified) Injection site swelling (prespecified) Intestinal obstruction Malaise (prespecified) Mortality Myalgia (prespecified) Neoplasm malignant Pickwickian syndrome Tonsillar haemorrhage Upper limb fracture
Tetanus, diphtheria (TD; TDVAX, Tenicac)	N/A
Varicella (VAR; varix)	N/A
Zoster (recombinant, RZV [shingrix]; live ZV [Zostavax])	Abdominal abscess Abdominal adhesions Abdominal discomfort Abdominal hernia Abdominal infection Abdominal pain Abdominal pain upper Abdominal strangulated hernia Abnormal behaviour Abortion missed Abscess Accident Accidental death Accidental overdose Acquired claw toe Acral lentiginous melanoma Actinic keratosis Acute coronary syndrome Acute graft versus host disease Acute hepatic failure Acute kidney injury Acute left ventricular failure Acute leukaemia Acute monocytic leukaemia Acute myeloid leukaemia Acute myocardial infarction Acute prerenal failure Acute promyelocytic leukaemia differentiation syndrome Acute psychosis Acute pulmonary oedema Acute respiratory distress syndrome Acute respiratory failure Adenocarcinoma Adenocarcinoma gastric Adenocarcinoma of colon Adenocarcinoma pancreas Administration site erythema Administration site pain Adrenal adenoma Adrenal gland cancer Adverse drug reaction Affective disorder Age-related macular degeneration Agranulocytosis Alcaligenes infection Alcohol withdrawal syndrome Allergic granulomatous angiitis Amaurosis fugax Amnesia Amyloidosis Amyotrophic lateral sclerosis Anaemia Anaemia vitamin b12 deficiency Anaemia vitamin b2 deficiency Anal abscess Anal fissure Anal fistula infection Anal prolapse Anaphylactic reaction Anaplastic astrocytoma Anaplastic thyroid cancer Aneurysm Aneurysm ruptured Angina pectoris Angina unstable Angiocentric lymphoma Angioedema Angioimmunoblastic t-cell lymphoma Ankle fracture Anorectal cellulitis Anxiety disorder Aortic aneurysm Aortic aneurysm rupture Aortic arteriosclerosis Aortic dissection Aortic occlusion Aortic rupture Aortic stenosis Aortic valve disease Aortic valve incompetence Aortic valve stenosis Appendiceal abscess Appendicitis Appendicitis perforated Arrhythmia Arrhythmia supraventricular Arteriosclerosis Arteriosclerosis coronary artery Arteriosclerotic gangrene Arteriovenous fistula Arthralgia Arthritis Arthritis bacterial Arthritis infective Arthrofibrosis Arthropathy Ascites Aspergillus infection Aspiration Asthenia Asthma Asthmatic crisis Ataxia Atelectasis Atrial fibrillation Atrial flutter Atrial tachycardia Atrial thrombosis Atrioventricular block Atrioventricular block complete Atrioventricular block first degree Atrioventricular block second degree Atrophic vulvovaginitis Atypical pneumonia Autoimmune haemolytic anaemia Autoimmune pancreatitis Autoimmune thyroiditis B precursor type acute leukaemia Back injury Back pain Bacteraemia Bacterial infection Bacterial sepsis Balance disorder Barrett’s oesophagus Basal cell carcinoma Basal ganglia haemorrhage Basedow’s disease Basilar artery thrombosis B-cell lymphoma Benign breast neoplasm Benign neoplasm of thyroid gland Benign ovarian tumour Benign prostatic hyperplasia Bile duct cancer Bile duct obstruction Bile duct stenosis Bile duct stone Biliary colic Biliary dilatation Biliary tract infection Bladder cancer Bladder cancer recurrent Bladder neck obstruction Bladder neoplasm Bladder papilloma Bladder perforation Bladder prolapse Bladder transitional cell carcinoma Bladder transitional cell carcinoma recurrent Blood creatine phosphokinase increased Blood glucose fluctuation Blood pressure inadequately controlled Blood pressure increased Bone cancer Bone fissure Bone pain Bowen’s disease Bradyarrhythmia Bradycardia Brain injury Brain neoplasm benign Brain stem infarction Brain stem syndrome Breast cancer Breast cancer metastatic Breast dysplasia Breathing-related sleep disorder Bronchial carcinoma Bronchiectasis Bronchiolitis Bronchitis Bronchitis bacterial Bronchitis chronic Bronchopneumonia Bronchopulmonary aspergillosis Bronchospasm Burkitt’s lymphoma Bursitis Cachexia Calculus ureteric Campylobacter gastroenteritis Candida infection Candida sepsis Carbon monoxide poisoning Carcinoid tumour pulmonary Cardiac amyloidosis Cardiac arrest Cardiac death Cardiac disorders Cardiac failure Cardiac failure acute Cardiac failure chronic Cardiac failure congestive Cardiac tamponade Cardiac valve disease Cardiogenic shock Cardiomegaly Cardiomyopathy Cardiomyopathy alcoholic Cardiopulmonary failure Cardio-respiratory arrest Cardiovascular deconditioning Cardiovascular insufficiency Carotid artery occlusion Carotid artery stenosis Carotid sinus syndrome Carpal tunnel syndrome Cataract Catheter site infection Cavernous sinus thrombosis Cellulitis Central nervous system lesion Central nervous system lymphoma Central nervous system neoplasm Cerebellar haemorrhage Cerebellar ischaemia Cerebral artery embolism Cerebral artery thrombosis Cerebral atrophy Cerebral haemorrhage Cerebral infarction Cerebral ischaemia Cerebral thrombosis Cerebrospinal fistula Cerebrospinal fluid leakage Cerebrovascular accident Cerebrovascular disorder Cervical myelopathy Cervical spinal stenosis Cervical vertebral fracture Chest discomfort Chest injury Chest pain Chills Cholangiocarcinoma Cholangitis Cholangitis acute Cholecystitis Cholecystitis acute Cholecystitis chronic Cholecystitis infective Cholelithiasis Cholestasis Cholesteatoma Chondrocalcinosis Chondropathy Choroidal effusion Chronic gastritis Chronic graft versus host disease Chronic hepatic failure Chronic kidney disease Chronic lymphocytic leukaemia Chronic myeloid leukaemia Chronic obstructive pulmonary disease Chronotropic incompetence Circulatory collapse Cirrhosis alcoholic Clavicle fracture Clostridium bacteraemia Clostridium difficile colitis Clostridium difficile infection Coagulopathy Cognitive disorder Colitis Colitis ischaemic Colitis ulcerative Colon adenoma Colon cancer Colon cancer metastatic Colon neoplasm Colonic abscess Coma Completed suicide Compression fracture Concussion Confusional state Congenital cystic kidney disease Congestive cardiomyopathy Constipation Contusion Cor pulmonale Coronary artery disease Coronary artery insufficiency Coronary artery occlusion Coronary artery reocclusion Coronary artery restenosis Coronary artery stenosis Cough Craniocerebral injury C-reactive protein increased Crohn’s disease Cushingoid Cutaneous vasculitis Cyst Cystic fibrosis Cystitis Cystitis haemorrhagic Cystitis interstitial Cystitis klebsiella Cytomegalovirus infection Cytopenia Deafness neurosensory Death Decreased appetite Decubitus ulcer Deep vein thrombosis Deep vein thrombosis postoperative Dehydration Delirium Dementia Dementia alzheimer’s type Dementia with lewy bodies Demyelinating polyneuropathy Depressed mood Depression Dermal cyst Dermatitis allergic Dermatitis contact Dermatomyositis Device battery issue Device deposit issue Device dislocation Device failure Device leakage Device occlusion Device related infection Diabetes mellitus Diabetes mellitus inadequate control Diabetic coma Diabetic foot Diabetic foot infection Diabetic ketoacidosis Diaphragmatic disorder Diaphragmatic hernia Diaphragmatic hernia, obstructive Diarrhoea Diastolic dysfunction Diffuse large b-cell lymphoma Diffuse large b-cell lymphoma stage iv Diplopia Disorientation Disseminated intravascular coagulation Disturbance in attention Diverticulitis Diverticulum Diverticulum intestinal Diverticulum intestinal haemorrhagic Dizziness Drop attacks Drowning Drug eruption Drug hypersensitivity Drug use disorder Drug withdrawal syndrome Drug-induced liver injury Duodenal perforation Duodenal ulcer Duodenal ulcer haemorrhage Duodenal ulcer perforation Duodenitis Dural arteriovenous fistula Dysphagia Dyspnoea Dyspraxia Dysuria Ear and labyrinth disor Eczema Electrolyte imbalance Embolic stroke Embolism Emphysema Empyema Encephalitis Encephalitis viral Endocarditis Endocrine disorders Endometrial adenocarcinoma Endophthalmitis Enteritis Enterocolitis viral Enterovesical fistula Epididymitis Epiglottitis Epilepsy Epistaxis Epstein-barr virus associated lymphoproliferative disorder Epstein-barrviraemia Erysipelas Erythema (prespecified) Escherichia infection Escherichia sepsis Escherichia urinary tract infection Ewing’s sarcoma metastatic Extrasystoles Eye disorders Eye penetration Eyelid ptosis Face injury Facial bones fracture Facial paralysis Faecal incontinence Faecaloma Failure to thrive Fall Fallopian tube cancer Fatigue (prespecified) Fatty liver alcoholic Febrile infection Febrile neutropenia Femoral artery aneurysm Femoral artery occlusion Femoral neck fracture Femur fracture Fibula fracture Follicular thyroid cancer Foot deformity Foot fracture Forearm fracture Foreign body Fractured sacrum Functional gastrointestinal disorder Fungal pharyngitis Furuncle Gallbladder cancer Gallbladder perforation Gangrene Gastric cancer Gastric haemorrhage Gastric mucosal lesion Gastric perforation Gastric polyps Gastric ulcer Gastric ulcer haemorrhage Gastric ulcer perforation Gastritis Gastritis alcoholic Gastritis erosive Gastritis haemorrhagic Gastroenteritis Gastroenteritis clostridial Gastroenteritis norovirus Gastroenteritis salmonella Gastroenteritis viral Gastrointestinal angiodysplasia Gastrointestinal carcinoma Gastrointestinal disorders Gastrointestinal haemorrhage Gastrointestinal polyp haemorrhage Gastrointestinal stromal tumour Gastrointestinal tract adenoma Gastrointestinal viral infection Gastrooesophageal reflux disease General disorders General physical health deterioration Generalised oedema Generalised tonic-clonic seizure Gingival disorder Glaucoma Glioblastoma Glioblastoma multiforme Glomerulonephritis Goitre Gout Gouty arthritis Graft infection Graft versus host disease Graft versus host disease in gastrointestinal tract Graft versus host disease in liver Graft versus host disease in skin Gravitational oedema Guillain-barre syndrome Gun shot wound H1n1 influenza Haematochezia Haematoma Haematoma infection Haematotympanum Haematuria Haemoglobin decreased Haemolytic anaemia Haemoptysis Haemorrhage Haemorrhage intracranial Haemorrhagic anaemia Haemorrhagic stroke Haemorrhoidal haemorrhage Haemorrhoids Haemothorax Hairy cell leukaemia Hallucination Hand fracture Head injury Headache (prespecified) Heart rate decreased Heart valve incompetence Helicobacter infection Hemiparesis Hemiplegia Heparin-induced thrombocytopenia Hepatic cancer Hepatic cancer metastatic Hepatic cirrhosis Hepatic failure Hepatic function abnormal Hepatic neoplasm Hepatitis Hepatitis acute Hepatitis alcoholic Hepatitis b Hepatitis b reactivation Hepatitis cholestatic Hepatitis toxic Hepatobiliary disorders Hepatocellular carcinoma Hernia Hernia congenital Herpes simplex Herpes zoster Herpes zoster cutaneous disseminated Herpes zoster disseminated Herpes zoster meningitis Herpes zoster meningoencephalitis Herpes zoster oticus Hiatus hernia Hiccups Hip fracture Hodgkin’s disease Hospitalisation Humerus fracture Hydrocele Hydrocephalus Hydronephrosis Hyperbilirubinaemia Hypercalcaemia Hypercholesterolaemia Hypergammaglobulinaemia benign monoclonal Hyperglycaemia Hyperkalaemia Hyperlipidaemia Hyperparathyroidism Hyperparathyroidism primary Hypersplenism Hypertension Hypertensive crisis Hypertensive emergency Hypertensive heart disease Hyperthyroidism Hypertonia Hypertrophic cardiomyopathy Hyperventilation Hypoacusis Hypoaesthesia Hypocalcaemia Hypochromic anaemia Hypoglycaemia Hypokalaemia Hyponatraemia Hypophagia Hypopituitarism Hypotension Hypothyroidism Hypovolaemia Hypoxia Hypoxic-ischaemic encephalopathy Ileus Ileus paralytic Ill-defined disorder Immune thrombocytopenic purpura Immunoglobulins decreased Impaired healing Impetigo Incarcerated hernia Incarcerated inguinal hernia Incarcerated umbilical hernia Incision site infection Incisional hernia Infected dermal cyst Infection Infectious colitis Infective exacerbation of chronic obstructive airways disease Inferior vena caval occlusion Inflammation Influenza Influenza like illness Infusion site extravasation Inguinal hernia Inguinal hernia strangulated Injection site erythema Injection site pain Injection site swelling Injury Intermittent claudication Internal haemorrhage Interstitial lung disease Intervertebral disc disorder Intervertebral disc protrusion Intestinal adenocarcinoma Intestinal congestion Intestinal gangrene Intestinal haemorrhage Intestinal infarction Intestinal ischaemia Intestinal obstruction Intestinal perforation Intestinal polyp Intracardiac thrombus Intracranial aneurysm Intraventricular haemorrhage Invasive ductal breast carcinoma Invasive lobular breast carcinoma Invasive papillary breast carcinoma Iridocele Iritis Iron deficiency anaemia Irritable bowel syndrome Ischaemic cardiomyopathy Ischaemic hepatitis Ischaemic stroke Jaundice cholestatic Jaw fracture Joint dislocation Joint effusion Joint injury Kidney contusion Kidney infection Klebsiella bacteraemia Klebsiella infection Klebsiella sepsis Kyphosis Labile hypertension Labyrinthitis Laceration Lactic acidosis Lacunar infarction Large cell lung cancer Large intestinal obstruction Large intestine benign neoplasm Large intestine perforation Large intestine polyp Laryngeal cancer Left ventricular failure Left ventricular hypertrophy Leiomyosarcoma Lens dislocation Leukaemia Lichen planus Ligament sprain Limb crushing injury Limb injury Lipoma Liver abscess Liver function test abnormal Lobar pneumonia Localised infection Loss of consciousness Lower limb fracture Lower respiratory tract infection Lower respiratory tract infection bacterial Lumbar radiculopathy Lumbar spinal stenosis Lumbar vertebral fracture Lung abscess Lung adenocarcinoma Lung adenocarcinoma metastatic Lung adenocarcinoma stage iii Lung cancer metastatic Lung disorder Lung infection Lung neoplasm Lung neoplasm malignant Lymphadenitis Lymphadenopathy Lymphadenopathy mediastinal Lymphoma Macular cyst Macular hole Major depression Malaise Malignant fibrous histiocytoma of bone Malignant lymphoma unclassifiable high grade Malignant mast cell neoplasm Malignant melanoma Malignant neoplasm of ampulla of vater Malignant ovarian cyst Malignant palate neoplasm Mallory-weiss syndrome Malnutrition Mantle cell lymphoma Marasmus Marginal zone lymphoma Medical device site infection Melaena Memory impairment Meningioma Meningitis Meningitis meningococcal Meningitis pneumococcal Meningitis viral Meningoencephalitis herpetic Meniscal degeneration Meniscus injury Mental disorder Mental disorder due to a general medical condition Mental status changes Mesenteric artery embolism Mesenteric artery thrombosis Mesenteritis Mesothelioma Mesothelioma malignant Metabolic acidosis Metabolic encephalopathy Metastases to adrenals Metastases to bone Metastases to central nervous system Metastases to gastrointestinal tract Metastases to liver Metastases to lung Metastases to lymph nodes Metastases to meninges Metastases to peritoneum Metastases to stomach Metastasis Metastatic carcinoma of the bladder Metastatic gastric cancer Metastatic malignant melanoma Metastatic neoplasm Metastatic renal cell carcinoma Metastatic squamous cell carcinoma Microcytic anaemia Microscopic polyangiitis Miller fisher syndrome Mitral valve incompetence Mitral valve prolapse Mitral valve stenosis Mixed connective tissue disease Mixed dementia Motion sickness Mouth ulceration Mucosal inflammation Multi-organ failure Multiple fractures Multiple injuries Multiple organ dysfunction syndrome Muscle rupture Muscular weakness Musculoskeletal pain Myalgia Myalgia (prespecified) Myasthenia gravis Mycoplasma infection Myelitis Myelodysplastic syndrome Myeloid leukaemia Myocardial infarction Myocardial ischaemia Myoclonus Myositis Nasal septum deviation Nasopharyngitis Nausea Neck pain Necrosis ischaemic Necrotising fasciitis Necrotising fasciitis streptococcal Neoplasm malignant Neoplasm prostate Neovascular age-related macular degeneration Nephroangiosclerosis Nephrogenic anaemia Nephrolithiasis Nephropathy toxic Nerve compression Nervous system disor Neuralgia Neuroborreliosis Neurogenic bladder Neuropathy peripheral Neutropenia Neutropenic sepsis Neutrophil count decreased Non-cardiac chest pain Non-hodgkin’s lymphoma Non-small cell lung cancer Non-small cell lung cancer stage iv Normochromic normocytic anaemia Ocular hypertension Ocular vascular disorder Odontogenic cyst Oedema peripheral Oesophageal achalasia Oesophageal adenocarcinoma Oesophageal adenocarcinoma metastatic Oesophageal cancer metastatic Oesophageal candidiasis Oesophageal carcinoma Oesophageal haemorrhage Oesophageal spasm Oesophageal squamous cell carcinoma Oesophageal ulcer Oesophageal ulcer haemorrhage Oesophageal varices haemorrhage Oesophagitis Ophthalmic herpes zoster Optic ischaemic neuropathy Optic neuritis Oral candidiasis Orchitis Organ failure Organising pneumonia Oropharyngeal candidiasis Orthostatic hypotension Osteoarthritis Osteochondritis Osteomyelitis Osteoporosis Osteoporotic fracture Otitis media Otitis media chronic Ovarian abscess Ovarian cancer Ovarian cancer recurrent Ovarian cyst Ovarian epithelial cancer Ovarian germ cell teratoma benign Overdose Pain (prespecified) Pain in extremity Palpitations Pancreatic abscess Pancreatic carcinoma Pancreatic carcinoma metastatic Pancreatic cyst Pancreatic disorder Pancreatic fistula Pancreatic mass Pancreatic neoplasm Pancreatic neuroendocrine tumour Pancreatitis Pancreatitis acute Pancreatitis necrotising Pancytopenia Panic attack Panic disorder Papillary thyroid cancer Paraganglion neoplasm Parainfluenzae virus infection Paralysis Paraplegia Parapsoriasis Parathyroid tumour benign Parkinsonism Parkinson’s disease Partial seizures Patella fracture Pathological fracture Pelvic fracture Peptic ulcer Peptic ulcer haemorrhage Peptic ulcer perforation Pericardial effusion Pericarditis Periodontal disease Peripheral arterial occlusive disease Peripheral artery aneurysm Peripheral artery stenosis Peripheral artery thrombosis Peripheral ischaemia Peripheral swelling Peripheral t-cell lymphoma unspecified Peripheral vascular disorder Peritoneal cyst Peritoneal haemorrhage Peritonitis Peritonitis bacterial Pernicious anaemia Pharyngeal abscess Pharyngitis Pharyngo-oesophageal diverticulum Pituitary tumour benign Plasma cell leukaemia Plasma cell myeloma Plasmacytoma Pleural effusion Pleurisy Pleuritic pain Pneumococcal sepsis Pneumocystis jirovecii pneumonia Pneumonia Pneumonia aspiration Pneumonia bacterial Pneumonia fungal Pneumonia haemophilus Pneumonia influenzal Pneumonia klebsiella Pneumonia legionella Pneumonia necrotising Pneumonia parainfluenzae viral Pneumonia pneumococcal Pneumonia pseudomonal Pneumonia staphylococcal Pneumonia streptococcal Pneumonia viral Pneumonitis Pneumonitis chemical Pneumoperitoneum Pneumothorax Pneumothorax traumatic Polymyalgia rheumatica Polymyositis Polyneuropathy Polyp Portal hypertension Portal hypertensive gastropathy Post herpetic neuralgia Post procedural complication Post procedural haemorrhage Post procedural infection Post procedural pulmonary embolism Postoperative abscess Postoperative wound complication Postoperative wound infection Precursor t-lymphoblastic lymphoma/leukaemia Prerenal failure Presyncope Procedural intestinal perforation Procedural pain Proctitis Progressive supranuclear palsy Prostate cancer Prostate cancer metastatic Prostate cancer recurrent Prostate cancer stage iv Prostatic adenoma Prostatic obstruction Prostatitis Prostatomegaly Pseudarthrosis Pseudomembranous colitis Pseudomonas infection Psittacosis Psoas abscess Psoriasis Psychiatric disor Psychotic disorder Pubis fracture Pulmonary cavitation Pulmonary congestion Pulmonary embolism Pulmonary fibrosis Pulmonary haemorrhage Pulmonary mass Pulmonary oedema Pulmonary thrombosis Pulmonary tuberculosis Pulseless electrical activity Purulence Pyelonephritis Pyelonephritis acute Pyloric stenosis Pyrexia (prespecified) Radicular pain Radiculopathy Radius fracture Rash Rectal abscess Rectal adenocarcinoma Rectal adenoma Rectal cancer Rectal cancer recurrent Rectal haemorrhage Rectal perforation Rectal polypectomy Rectal prolapse Rectocele Redness (prespecified) Renal abscess Renal and urinary disor Renal cancer Renal cancer metastatic Renal cell carcinoma Renal cell carcinoma recurrent Renal colic Renal cyst Renal disorder Renal dysplasia Renal failure Renal hypertension Renal impairment Renal mass Renal neoplasm Renal oncocytoma Respiratory arrest Respiratory distress Respiratory failure Respiratory fume inhalation disorder Respiratory moniliasis Respiratory syncytial virus bronchitis Respiratory syncytial virus infection Respiratory tract infection Respiratory tract infection bacterial Respiratory, thoracic and mediastinal disor Restless legs syndrome Retinal artery occlusion Retinal degeneration Retinal detachment Retinal haemorrhage Retinal tear Retinal vein occlusion Retroperitoneal haemorrhage Rhabdomyolysis Rhabdomyosarcoma Rheumatoid arthritis Rib fracture Right ventricular failure Road traffic accident Rotator cuff syndrome Salivary gland calculus Salivary gland cancer Sarcoma Schizoaffective disorder bipolar type Schizophrenia Sciatica Seizure Senile dementia Sepsis Septic shock Serratia sepsis Shock haemorrhagic Sinus arrest Sinus node dysfunction Sinus tachycardia Sinusitis Sinusitis bacterial Sjogren’s syndrome Skin cancer Skin infection Skin necrosis Skin ulcer Skin wound Skull fracture Small cell lung cancer Small cell lung cancer metastatic Small intestinal obstruction Small intestine adenocarcinoma Soft tissue infection Somatoform disorder Somnolence Spinal column stenosis Spinal compression fracture Spinal cord abscess Spinal cord compression Spinal cord injury Spinal cord injury cervical Spinal fracture Spinal osteoarthritis Spinal pain Splenic artery aneurysm Splenic haemorrhage Splenic infarction Splenic rupture Spondylitic myelopathy Spondyloarthropathy Spondylolisthesis Squamous cell carcinoma Squamous cell carcinoma of lung Squamous cell carcinoma of skin Squamous cell carcinoma of the oral cavity Staphylococcal abscess Staphylococcal infection Staphylococcal osteomyelitis Staphylococcal scalded skin syndrome Staphylococcal sepsis Stasis dermatitis Status epilepticus Sternal fracture Still’s disease adult onset Stomatitis Strangulated hernia Streptococcal infection Streptococcal sepsis Stress cardiomyopathy Subarachnoid haemorrhage Subdural haematoma Subdural haemorrhage Subileus Sudden cardiac death Sudden death Sudden hearing loss Suicidal ideation Supraventricular tachycardia Sweat gland tumour Swelling (prespecified) Syncope Synovial cyst Synovial rupture Synovitis Systemic inflammatory response syndrome Systemic lupus erythematosus Systemic scleroderma Tachyarrhythmia Tachycardia T-cell lymphoma Temporal arteritis Tendon rupture Tenosynovitis Testicular cancer metastatic Testis cancer Thalamic infarction Thalamus haemorrhage Thermal burn Thoracic vertebral fracture Throat cancer Thromboangiitis obliterans Thrombocytopenia Thrombophlebitis Thrombosis Thrombosis in device Thrombosis mesenteric vessel Thrombotic cerebral infarction Thrombotic microangiopathy Thyroid cancer Thyroiditis subacute Tibia fracture Tongue neoplasm malignant stage unspecified Tonsillar hypertrophy Tonsillitis Tooth abscess Toxic skin eruption Toxicity to various agents Transaminases increased Transfusion reaction Transient global amnesia Transient ischaemic attack Transitional cell carcinoma Transitional cell carcinoma metastatic Traumatic fracture Traumatic intracranial haemorrhage Tricuspid valve incompetence Trigeminal neuralgia Trigger finger Tuberculosis Tubulointerstitial nephritis Tumour lysis syndrome Tumour pain Tympanic membrane perforation Type 2 diabetes mellitus Ulna fracture Umbilical hernia Upper gastrointestinal haemorrhage Upper limb fracture Upper respiratory tract infection Uraemic acidosis Urethral haemorrhage Urethral meatus stenosis Urethral neoplasm Urethral stenosis Urinary incontinence Urinary retention Urinary tract disorder Urinary tract infection Urinary tract infection bacterial Urosepsis Urticaria Uterine polyp Uterine prolapse Vaginal haemorrhage Vaginal prolapse Vaginal ulceration Varicose vein Vascular dementia Vascular disor Vascular graft occlusion Vascular pseudoaneurysm Vasculitis Venous thrombosis Venous thrombosis limb Ventricular arrhythmia Ventricular dysfunction Ventricular extrasystoles Ventricular fibrillation Ventricular tachycardia Vertebrobasilar insufficiency Vertigo Vertigo positional Vestibular disorder Vestibular neuronitis Viiith nerve lesion Viith nerve paralysis Viral infection Vith nerve paralysis Vitreous detachment Vitreous haemorrhage Volvulus Vomiting Vulval cancer Vulvitis Weight increased Wound Wound dehiscence Wound evisceration Wound haemorrhage Wound infection Wrist fracture

: Note: N/A—not applicable

The next two tables show the adverse events assessed in KQ2 studies. The first table shows events that were assessed across studies that included only children.

Table C.2Assessed adverse events for vaccines in children

Vaccine	Assessed Adverse Events
Diphtheria, tetanus, & acellular pertussis (DTaP)	Asthma Cough Death Dehydration Diarrhoea Erythema (prespecified) Foreign Body Increased respiratory support Injection Site Erythema Injection Site Pain Injection Site Swelling Intubation Intussusception Irritability Lymphadenitis Nasopharyngitis Otitis Media Pain/Tenderness (prespecified) Pneumonia Pyrexia (prespecified) Rhinitis Rhinorrhoea Seizure Sepsis evaluation Subcutaneous Abscess Swelling (prespecified) Teething Upper Respiratory Tract Infection Vomiting
Tetanus, diphtheria, & acellular pertussis (Tdap; Adacel, Boostrix)	N/A
Hepatitis A (HepA; Havrix, Vaqta)	Anorexia nervosa Anxiety disorder Attention deficit hyperactivity disorder Bipolar disorder Broken bone Major depression Obsessive–compulsive disorder (OCD) Open wound Tic disorder
Hepatitis B (HepB; Engerix-B, Recombivax HB)	Anorexia nervosa Anxiety disorder Attention deficit hyperactivity disorder Bipolar disorder Broken bone Death Increased respiratory support Intubation Major depression Obsessive–compulsive disorder (OCD) Open wound Seizure Sepsis evaluation Tic disorder
Haemophilus influenzae type b (Hib; PedvaxHIB, ActHIB, Hiberix)	Death Increased respiratory support Intubation Intussusception Seizure Sepsis evaluation
Human papillomavirus (HPV9; Gardasil 9)	Anaemia Arthralgia Complex partial seizures Fatigue Fever Gastro-intestinal Headache Henoch-Schonlein purpura Injection-site erythema Injection-site pain Injection-site swelling Myalgia Nasopharyngitis Nausea Oropharyngeal pain Pain Pulmonary vasculitis Pyrexia Rash Redness Swelling Upper abdominal pain Urticaria
Inactivated polio vaccine (IPV; IPOL)	Death Increased respiratory support Intubation Intussusception Seizure Sepsis evaluation
Inactivated influenza (IIV; Afluria Quadrivalent, Fluarix Quadrivalent, Flulaval Quadrivalent, Fluzone Quadrivalent, Flucelvax Quadrivalent)	Abscess neck Abscess Of Eyelid Accidental exposure Accidental overdose Acute disseminated encephalomyelitis (ADEM) Adenoidal hypertrophy Affective disorder Amoebic dysentery Anaphylactic Reaction Anaphylaxis Angioedema Anxiety Appendicitis Appetite lost Arthralgia Asthma Astrocytoma, low grade Autism Bacterial pyelonephritis Bell’s palsy Biliary dyskinesia Bipolar Disorder Blastocystis infection Bradycardia Bronchial hyperreactivity Bronchiolitis Bronchopneumonia Cellulitis Chills (prespecified) Colitis ulcerative Conjunctivitis Convulsion Cough Craniocerebral Injury Croup infectious Crying abnormal Decreased Appetite (prespecified) Dehydration Dengue fever Depression Diarrhea (prespecified) Diarrhoea Drowning Drowsiness (prespecified) Ecchymosis (prespecified) Encephalitis Facial bones fracture Failure to thrive Fatigue (prespecified) Febrile convulsion Febrile seizures Femur fracture Fever (prespecified) Forearm Fracture Foreign body Gastroenteritis Gastroenteritis rotavirus Gastroenteritis viral Gastrointestinal symptoms (prespecified) Grand mal convulsion Guillain–Barré syndrome (GBS) Head injury Headache (prespecified) Henoch-Schonlein Purpura Hippocampal Sclerosis Humerus Fracture Hypersensitivity Hypertension Hypovolaemia Infections and infestations Influenza Injection Site Erythema (prespecified) Injection Site Hemorrhage Injection Site Induration (prespecified) Injection Site Pain (prespecified) Injection site pain, redness, swelling (prespecified) Injection site Swelling Injection site tenderness Intentional Self-Injury Intestinal obstruction Irritability (prespecified) Irritability/fussiness (prespecified) Joint dislocation Joint pain at other location (prespecified) Kawasaki’s disease Lobar pneumonia Loss of appetite (prespecified) Lymphadenitis Major Depression Malaise Malignant melanoma Muscle aches (prespecified) Myalgia Mycoplasma infection Nasopharyngitis Nausea (prespecified) Oppositional Defiant Disorder Otitis media Otitis media acute Pain (prespecified) Partial Seizures Periorbital Cellulitis Peritonitis Peritonsillar abscess Pharyngitis streptococcal Pneumonia Pneumonia aspiration Pneumonia viral Pyrexia Redness (prespecified) Respiratory arrest Respiratory syncytial virus bronchiolitis Respiratory syncytial virus infection Retina detachment Rhinorrhoea Rotavirus infection Seizure anoxic Septic shock Shivering (prespecified) Sleep Apnoea Syndrome Staphylococcal abscess Staphylococcal infection Status asthmaticus Suicidal Ideation Suicide Attempt Swelling (prespecified) Temperature/Fever (prespecified) Tonsillitis Transverse myelitis Traumatic brain injury Upper Respiratory Tract Infection Urticaria Uticaria Viral infection Viral upper respiratory tract infection Vitello-intestinal duct remnant Vomiting (prespecified)
Live attenuated influenza (LAIV; FluMist Quadrivalent)	Acute respiratory failure Appendicitis Asthma Bell’s palsy Blepharitis Bronchiolitis Convulsion Cough Croup Decreased Appetite Diaper dermatitis Encephalitis Fever (prespecified) Gastroenteritis Generalized Muscle Aches Guillain-Barre syndrome Headache Hydronephrosis Hypersensitivity Laceration Lethargy Narcolepsy Nasopharyngitis Neuritis Osteochondrosis Peritonsillar abscess Pharyngitis/asthma Pneumonia Renal and urinary disorders Runny/Stuffy Nose Seizures Sore Throat Thumb issue Upper respiratory infection/allergy Vasculitis Viral illness Vomiting Wheezing
Measles, mumps, rubella (MMR; M-M-R II)	Autism Intussusception Seizure
Meningococcal, Quadrivalent [MenACWY-D (Menactra), MenACWY-CRM (Menveo), MenACWY-TT (MenQuadfi)]	Abdominal adhesions Abdominal pain Abnormal Behaviour Abscess limb Abscess neck Abscess oral Acarodermatitis Accidental drug intake by child Accidental exposure Accidental overdose Accidental Poisoning Acne Acute bronchitis Acute Disseminated Encephalomyelitis Acute myeloid leukaemia Acute sinusitis Acute Tonsilitis Adenoidal Hypertrophy Adenovirus Infection Affective disorder Aggression Allergic reactions Anaemia Angiopathy Apnoea Appendicitis Arthralgia Arthritis bacterial Ascariasis Aspergillosis Asthma Asthmatic Crisis Atelectasis Atopic dermatitis Atrial septal defect Bacteraemia Bacterial diarrhoea Bacterial Tracheitis Balanitis Blepharitis Botulism Brain Death Brain neoplasm Brain stem dysfunction, Breath Holding Bronchial hyperreactivity Bronchiolitis Bronchitis Bronchitis viral Bronchomalacia Bronchopneumonia Bronchospasm Burns second degree Cardiac Arrest Cellulitis Cellulitis and abscess Cellulitis Staphylococcal Cellulitis Streptococcal Cellulitis/abscess Cerebral palsy Change in eating habit Chest Wall Abscess Chills Choking Complex partial seizures Congenital anomaly of ureter Congenital atresia Congenital cardiac condition, Conjunctivitis Constipation Contusion Convulsion Cough Cow’s milk intolerance Craniocerebral Injury Croup infectious Crying Cyanosis Death Dehydration Dengue fever Dermal Cys Dermatitis Atopic Dermatitis Diaper Diabetes mellitus Diabetic ketoacidosis Diarrhea Diarrhoea haemorrhagic Diarrhoea Infectious Digestive congenital anomalies Drug Abuse Drug hypersensitivity Dysentery Dyspepsia Eating Disorder Eating disorders Eczema Electrical Burn Electrocardiogram Qt Prolonged Enteritis Enteritis infectious Enterocolitis Enterovirus Infection Epilepsy Epistaxis Erythema Erythema Multiforme Escherichia Urinary Tract Infection Exanthema Subitam Eye disorders Faecaloma Failure To Thrive Fall Fallot’s tetralogy Fatigue Febrile convulsion Febrile illness Febrile infection Feeding Disorder Feeding problem Fever Flatulence Food allergy Foreign body Foreign body aspiration Furuncle Gastritis Gastroenteritis Gastroenteritis Rotavirus Gastroenteritis Salmonella Gastroenteritis viral Gastrooesophageal reflux disease Genital Abscess Grand mal convulsion Groin Abscess Haematochezia Haematotympanum Haematuria Haemophilus Bacteraemia Hand-Foot-And-Mouth Disease Head injury Head injury due to a fall, Headache Hereditary spherocytosis Hernia Hernia Repair Herpangina Humerus Fracture Hydrocephalus Hydronephrosis Hypogammaglobulinaemia Hypoglycaemia Hyponatraemia Hypospadias Hypothyroidism Hypoxia Ileus Impetigo Incision Site Cellulitis Induration Infected Cyst Infectious mononucleosis Influenza Ingrown nail Inguinal hernia Inguinal Hernia Repair Inguinal Hernia, Obstructive Injection Site Erythema Injection Site Induration Injection Site Pain Injection Site Swelling Injury Intestinal obstruction Intestinal operation Intussusception Iron Deficiency Anaemia Irritability Jaundice Kawasaki’s Disease Klebsiella Bacteraemia Laryngospasm Leukocytosis Limb traumatic amputation Lobar Pneumonia Local tenderness Lower Respiratory Tract Infection Lung infection Lymph Node Abscess Lymphadenitis Lymphadenopathy Major Depression Malaise Malignant neoplasm Malignant neoplasm Meningitis Enteroviral Meningitis Viral Mental Status Changes Mesenteric Lymphadenopathy Metabolic Acidosis Metapneumovirus Infection Mucosal Inflammation Myalgia Nasal congestion Nasopharyngitits Nausea Nausea with vomiting Nephrotic syndrome Noninfectious gastroenteritis Nosocomial pneumonia Oedema Optic nerve hypoplasia Osteomyelitis Otalgia Other non-traumatic joint disorders Otitis externa Otitis Media Otitis Media Acute Pain in soft tissues of limb Painful respiration Palpitations Periorbital Cellulitis Peritonitis Peritonsillar Abscess Persistent crying Pertussis Pharyngitis Pharyngotonsillitis Pneumococcal bacteraemia Pneumonia Pneumonia Adenoviral Pneumonia Aspiration Pneumonia Bacterial Pneumonia Influenzal Pneumonia Primary Atypical Pneumonia Respiratory Syncytial Viral Pneumonia Viral Pneumonitis Post Procedural Complication Presyncope Psychiatric Psychiatric disorders Psychomotor skills impaired Pulmonary edema and pneumonitis Pulmonary hypertension Pulmonary Oedema Pulmonary valve stenosis Pyelonephritis Pyelonephritis Acute Pyloric stenosis Pyogenic arthritis Pyrexia Rash Renal Failure Acute Renal Mass Respiratory disorder Respiratory Distress Respiratory Failure Respiratory infection, upper Respiratory Synctial Virus Infection Respiratory Syncytial Virus Bronchiolitis Respiratory tract infection Respiratory tract infection viral Retinal Haemorrhage Rib fracture Road traffic accident Rotavirus Infection Scrotal mass Seizure-like activity and fever Sepsis Septic Shock Sickle Cell Anemia Sinusitis Skull Fracture Sleep apnoea syndrome Sleepiness Small bowel obstruction Small intestinal obstruction Somnolence Staphylococcal Abscess Staphylococcal Infection Staphylococcal Scalded Skin Syndrome Staphylococcal skin infection Status Asthmaticus Stomatitis Subarachnoid haemorrhage Subcutaneous abscess Subdural Haemorrhage Subdural Hematoma Suicidal Ideation Supraventricular Tachycardia Syncope Synostosis Tachypnoea Teething Thermal Burn Thrombocytopenia Tibia Fracture Tonic Convulsion Tonsilitis Trauma Traumatic brain injury Tremor Type 1 Diabetes Mellitus Upper Limb Fracture Upper Respiratory Tract Infection Urachal Abscess Urinary Tract Infection Urinary Tract Infection Enterococcal Urosepsis Urticaria Varicella Vasculitis Ventricular Tachycardia Vesicoureteric Reflux Viral Diarrhoea Viral Infection Viral pharyngitis Vomiting Vulval abscess Warts Wheezing Wound Infection
Meningococcal B (MenB; MenB-4C [Bexsero], MenB-FHbp (Trumenba)]	Abdominal abscess Abdominal injury Abdominal pain Abnormal behaviour Acarodermatitis Acne Acute tonsillitis Adenoidectomy Adenoma benign Alcohol poisoning Allergic conjunctivitis Allergy to animal Allergy to chemicals Alopecia Anaphylactic reaction Anaphylaxis Ankle fracture Appendicitis Appendicitis perforated Arthralgia (prespecified) Arthritis infective Arthropathy Arthropod bite Asthma Asthma exercise induced Asthmatic crisis Back injury Back pain Bengin ovarian tumour Blood iron decreased Bronchitis Burning sensation mucosal Cardiac disorders Cellulitis Cerebellar tumour Chemical burn of skin Chest injury Chest pain Chills Circumcision CNS germinoma Concussion Conjunctivitis Contusion Convulsion Costochondritis Cough Death Decreased appetite (prespecified) Dental caries Depression Dermatitis Dermatitis allergic Dermatitis atopic Dermatitis contact Diarrhea Dizziness Drug abuse Drug eruption Dysentery Dysmenorrhoea Dyspepsia Dyspnoea Ear infection Ear pain Eating Disorders Eczema Eczema impetiginous Electrocardiogram QT prolonged Epilepsy Epistaxis Erythema Eye disorders Eye inflammation Eyelid cyst Factor V Leiden mutation Fainting (syncope) Fatigue Fever Fibroma Food poisoning Foot fracture Forearm fracture Foreign body Furuncle Gastritis viral Gastroenteritis Gastroenteritis rotavirus Gastroenteritis viral Gingivitis Glomerulonephritis minimal lesion Glossodynia H1N1 influenza Hand fracture Hangnail Head injury Headache (prespecified) Herpes simplex Hip fracture Histiocytic necrotising lymphadenitis Hordeolum Hydrocephalus Hypertension Hypothermia Idiopathic thrombocytopenic purpura Immune system disorders Impetigo Induration Influenza Influenza like illness Ingrowing nail Inguinal hernia Injection site dermatitis Injection site erythema (prespecified) Injection site haematoma Injection site induration (prespecified) Injection site pain (prespecified) Injection site pallor Injection site paraesthesia Injection site pruritus Injection site swelling (prespecified) Injury Investigations Irritable bowel syndrome Jaw fracture Joint dislocation Joint injury Joint sprain Juvenile idiopathic arthritis Laryngitis Ligament injury Ligament rupture Ligament sprain Limb injury Local reactions (redness, swelling, and pain) (prespecified) Lower respiratory tract infection Lymphadenitis Lymphadenopathy Lymphangitis Major depression Malaise (prespecified) Meningitis bacterlal Migraine Mononucleosis syndrome Mouth ulceration Mumps Muscle contracture Muscle Pain Myalgia (prespecified) Nasopharyngitis Nausea (prespecified) Neck pain Nervous system disorders Oropharyngeal pain Otitis media Ovarian cyst Ovarian cyst ruptured Pain Pain (bodyache) Pain at the injection site Pain in extremity Palpitations Panic attack Parovarian cyst Penile discharge Perirectal abscess Peritonsillar abscess Pertussis Pharyngitis Photophobia Photosensitivity reaction Pilonidal cyst Pneumonia Pneumonia viral Post concussion syndrome Post procedural haematoma Premature labour Presyncope Procedural pain Psychiatric disorders Pulpitis dental Pyelonephritis Pyrexia Pyrexia/Fever (prespecified) Radius fracture Rash Redness Respiratory tract infection Respiratory tract infection viral Rheumatoid arthritis Rhinitis Rhinitis allergic Rhinorrhoea Road traffic accident Scar Scarlet fever Scoliosis Seasonal allergy Shigellain fection Sinusitis Skeletal injury Skin abrasion Skin laceration Soft tissue injury Stomatitis Subcutaneous abscess Suicide attempt Swelling Syncope Tendonitis Testicular torsion Thermal burn Tonsillectomy Tonsillitis Tonsillitis streptococcal Tooth extraction Tooth impacted Toothache Torticollis Toxicity to varlous agents Tremor Upper limb fracture Upper respiratory tract infection Urinary tract infection Urticaria Use of antipyretic medications Vaccination site pallor Vertigo Vertigo positional Vessel puncture site haematoma Viral infection Viral upper respiratory tract infection Vocal cord thickening Vomiting Whiplash injury Wrist fracture
Pneumococcal polysaccharide vaccine (PPSV23; Pneumovax)	Abdominal pain Abscess Accidental poisoning Acetonaemic vomiting Acute sinusitis Acute tonsillitis Acutelymphocytic leukemia Adenoidal hypertrophy Adenoiditis Adenoviral conjunctivitis Adenovirus infection Anaemia Anal abscess Anal fissure Anal fungal infection Anaphylaxis Anemia Animal bite Antibiotic prophylaxis Apathy Aphthous stomatitis Apparent life threatening event Application site erythema Arthralgia Arthritis bacterial Arthropod bite Arthropod sting Asphyxiation Aspiration of food Asteatosis Asthma Bacteraemia Bacterial infection Balanoposthitis Blepharitis Body height below normal Breast swelling Breath holding Bronchial hyperreactivity Bronchiolitis Bronchitis Bronchitis viral Bronchopneumonia Brucellosis Bruise Bullous impetigo Burns second degree Candidiasis Cardiac disorders Cardiac failure congestive Cardiac failure congestive and heart disease congenital Cellulitis Cellulitis orbital Cephalhaematoma Cerebral infarction Cheilitis Chillblains Chills Choking Conjunctivitis Conjunctivitis allergic Conjunctivitis bacterial Conjunctivitis infective Conjunctivitis viral Constipation Contusion Convulsion Corneal perforation Corynebacterium infection Cough Croup infectious Cyanosis Dacryostenosis acquired Dacryostenosis congenital Deafness bilateral Death Decreased appetite (prespecified) Decreased sleep (prespecified) Dehydration Dermatitis Dermatitis atopic Dermatitis contact Dermatitis diaper Developmental delay Diarrhoea Diet refusal Dry skin Dysentery Dyspnoea Dysuria Ear haemorrhage Ear infection Ear injury Echo virus infection Eczema Eczema asteatotic Eczema infantile Encephalopathy Endophthalmitis Enteritis infectious Epistaxis Erysipelas Erythema Erythema infectiosum Escherichia urinary tract infection Exanthema subitum Excoriation Exposure to toxic agent External ear cellulitis Eye discharge Eye disorders Eye injury Eye movement disorder Eye pruritus Eye swelling Eyelid oedema Fall Febrile convulsion Febrile seizure Feeding disorder Femur fracture Fever (prespecified) Fever After Vaccination Fibrinous bronchitis Folliculitis Fontanelle bulging Food allergy Foreign body Fracture Frostbite Gait disturbance Gastroenteritis Gastroenteritis bacterial Gastroenteritis norovirus Gastroenteritis rotavirus Gastroenteritis viral Genital candidiasis Genital infection fungal Genital labial adhesions Gianotti-Crosti syndrome Gingivitis Grunting H1N1 influenza Haemangioma of skin Haematemesis Haematochezia Haematoma Haemoptysis Haemorrhage subcutaneous Haemorrhoidal haemorrhage Hand fracture Hand-foot-and-mouth disease Head injury Heat rash Henoch-Schonlein purpura Hepatomegaly Hepatosplenomegaly Herpangina Herpes simplex Hives (urticaria) (prespecified) Hordeolum Hyperkeratosis palmaris and plantaris Hypertension Hypotonia Hypoxia Impetigo Increased sleep (prespecified) Infantile asthma Infantile spasms Infected bites Infection Infectious mononucleosis Inflammation Influenza Influenza virus test positive Ingrowing nail Injection site dermatitis Injection site erythema Injection site induration Injection site redness Injection site swelling Injection site tenderness Intervertebral discitis Intussusception Investigations Iron deficiency anaemia Irritability (prespecified) irritability/fussiness Joint dislocation Kawasaki disease Keratitis Kidney enlargement Laboratory test Laceration Lactose intolerance Laryngitis Leukocytosis Leukocyturia Leukopenia Limb injury Lip swelling Localised infection Lower respiratory tract infection Lung infiltration Lymphadenitis Lymphadenopathy Medulloblastoma Melaena Meningitis Meningitis aseptic Meningitis viral Meningococcal infection Metabolic acidosis Milk allergy Molluscum contagiosum Monarthritis Mouth injury Muscular weakness Mycoplasma infection Myoclonic epilepsy Nasal obstruction Nasopharyngitis Near drowning Nervous system disorder Neuritis cranial Neutropenia Oedema peripheral Omphalitis Onychomadesis Oral candidiasis Oral disorder Oral fungal infection Oral herpes Oral infection Osteomyelitis Otitis externa Otitis media Otitis media acute Otorrhoea Overfeeding of infant Pain in extremity Papule Parainfluenzae virus infection Paronychia Parotitis Partial seizures Periorbital cellulitis Perirectal abscess Pertussis Petechiae Pharyngeal erythema Pharyngitis Pharyngotonsillitis Pityriasis rosea Pneumococcal bacteraemia Pneumonia Pneumonia influenzal Pneumonia respiratory syncytial viral Pneumonia viral Pneumonitis Post procedural haemorrhage Posthitis Postoperative fever Postoperative wound infection Pruritus Psychiatric disorders Pulmonary artery stenosis Pulmonary tuberculosis Pyrexia Radius fracture Rash Rash generalised Rash macular Rash maculo-papular Rash pustular Rectal haemorrhage Redness (prespecified) Respiratory distress Respiratory syncytial virus bronchiolitis Respiratory syncytial virus bronchitis Respiratory syncytial virus infection Respiratory tract infection Restlessness Rhinitis Rhinitis allergic Rhinorrhoea Rhrombocytopenia Road traffic accident Rotavirus infection Scar Scarlet fever Scratch Seborrhoeic dermatitis Septic shock and status epilepticus Sinusitis Skin candida Skin infection Skull fracture Skull fractured base Sleep apnoea syndrome Somnolence Status epilepticus Stomatitis Streptococcal bacteraemia Streptococcal infection Stridor Subcutaneous abscess Sudden death Swelling (prespecified) Swollen tongue Tenderness (prespecified) Testicular torsion Thermal burn Tonsillitis Tooth abscess Tooth fracture Tooth injury Tracheitis Trigger finger Tympanic membrane hyperaemia Upper respiratory tract infection Urinary tract infection Urine analysis abnormal Urticaria Urticaria and angioneurotic edema Use of antipyretic medication to treat symptoms (prespecified) Varicella Vascular disorders Ventricular septal defect Vesicoureteric reflux Viral infection Viral rash Vomiting Vulvovaginal candidiasis Weight gain poor Wheezing White blood cells urine positive Wound infection
Rotavirus (RV; Rotarix, RotaTeq)	Abdominal distention Abdominal mass Acidosis Acute gastroenteritis Acute lymphocytic leukaemia Acute tonsillitis Agranulocytosis All-cause ED visit All-cause hospitalization All-cause mortality Anaemia Apnea Appendicitis Asphyxia Asthma Bacterial diarrhoea Blood detected on rectal exam Blood in Stool Bloody stool Bradycardia Brain contusion Brain herniation Bronchiolitis Bronchitis Bronchitis viral Bronchopneumonia Burns second degree Burns third degree Candida infection Candidiasis Cardiomyopathy Cataract Central nervous system infection Central nervous system lesion Cerebral haematoma Congenital absence of bile ducts Conjunctivitis Constipation Convulsions (prespecified) Cough Cough/runny nose Croup infectious Crying Cytomegalovirus infection Death Deficiency anaemia Dehydration Dermatitis allergic Dermatitis atopic Dermatitis diaper Developmental delay Diabetes (prespecified) Diarrhoea (prespecified) Diarrhoea infectious Drowning Drowsiness Dyspepsia Eczema Eczema infantile Elevation in mode of ventilation Encephalitis Encephalitis/encephalopathy Enteritis Epilepsy (prespecified) Epyema Exanthema subitum Extrapyramidal disorder Eye contusion Eye disorders Febrile convulsion Febrile Convulsions Feeding intolerance Fever Food poisoning Functional gastrointestinal disorder Gastritis Gastroenteritis Gastroenteritis adenovirus Gastroenteritis bacterial Gastroenteritis rotavirus Gastroenteritis shigella Gastrointestinal (nausea, vomiting, diarrhea and/or abdominal pain Gastrointestinal disorder Gastrooesophageal reflux disease GI bleeding Gingivitis Granulocytopenia Haemorrhage intracranial Hand-foot-and-mouth disease Hematochezia Hepatic function abnormal Hernia Herpangina Herpes virus infection Histiocytosis haematophagic Hospitalization due to acute lower respiratory tract infection Hydrocephalus Hydronephrosis Hypoglycaemia Hypokalaemia Hypomagnesaemia Hyponatraemia Idiopathic thrombocytopenic purpura Incarcerated inguinal hernia Increased proportion of stools defined as “loose” Infantile spasms Infantile spitting up Infection Infectious mononucleosis Influenza Inguinal hernia Inguinal hernia, obstructive Injection site reactions (redness, swelling, tenderness) Intestinal obstruction Intussusception (prespecified) Irritability Irritability/Fussiness Kawasaki disease Laryngitis Lethargy Liver function test abnormal Lobar pneumonia Loss of appetite Lymphadenitis Malnutrition Megaloblastic anaemia Meningitis Meningitis coxsackie viral Multi-organ failure Myocarditis Myoclonus (prespecified) Nasal congestion Nasopharyngitis Nonbilious emesis Omphalitis Oral candidiasis Oral herpes Oral infection Otitis Media Overdose Pain Pallor Pharyngitis Pharyngitis bacterial Pneumonia Pneumonia klebsiella Pneumonia staphylococcal Presence of feeding intolerance Psychomotor retardation Pyrexia Rash Rectal mass Redness Respiratory failure Respiratory syncytial virus bronchiolitis Respiratory syncytial virus infection Rhinitis Rhinorrhoea Rickets Rotavirus-attributable gastroenteritis Seizure Sepsis Shigella infection Sinusitis Skull fracture Subarachnoid haemorrhage Sudden death Swelling Thrombocytopenia Tonsillitis Tonsillitis bacterial Toxoplasmosis Tracheitis Tracheobronchitis Transient hypogammaglobulinaemia of infancy Type 1 diabetes mellitus (prespecified) Upper respiratory tract Upper respiratory tract infection Upper respiratory tract inflammation Ureteric stenosis Urinary tract infection Urinary tract stone Urticaria Varicella Vomiting (prespecified)
Varicella (VAR; Varivax)	Anorexia nervosa Anxiety disorder Attention deficit hyperactivity disorder Bipolar disorder Broken bone Encephalitis Intussusception Ischemic stroke Major depression Obsessive–compulsive disorder (OCD) Open wound Seizure Tic disorder
DTap-HepB-IPV (Pediarix)	Death Increased respiratory support Intubation Seizure Sepsis evaluation
DTaP-IPV/Hib (Pentacel)	Alteration of consciousness (other than secondary to another diagnosis) Anaphylaxis Cardiac and circulatory congenital anomalies Certain conditions originating in the perinatal period Death Diseases of the genitourinary system Diseases of the respiratory system Diseases of the skin and subcutaneous tissue Encephalitis Encephalopathy Fever of unknown origin Fractures Genitourinary symptoms and ill-defined conditions Guillain-Barré Syndrome Hypersensitivity reactions (urticaria, angioedema, or anaphylaxis; post-vaccination days 0–3 only) Hypovolemia Increased respiratory support Infectious and parasitic diseases Injury and poisoning Intubation Invasive Hib disease Kawasaki disease Medically attended fever Meningitis/encephalitis/myelitis Nausea and vomiting New-onset autoimmune disease (immune thrombocytopenic purpura [ITP], hemolytic anemia) Other and unspecified lower respiratory disease Other and unspecified perinatal conditions Other lower respiratory disease Other perinatal conditions Pre-specified outpatient outcomes: Seizure Sepsis evaluation Serious nonanaphylactic allergic reaction Skin and subcutaneous tissue infections Skull and face fractures Symptoms; signs; and ill-defined conditions and factors influencing health status Type 1 diabetes
DTaP-IPV (Kinrix, Quadracel)	Anaphylaxis Guillain–Barré syndrome Meningitis/encephalitis Seizures Serious allergic reactions other than anaphylaxis Serious local reactions Stevens–Johnson syndrome Stroke
DTaP-IPV-Hib-HepB	Abnormal crying Abnormal weight gain Abscess Accidental overdose Anal fistula Apnoeic attack Apparent life-threatening event Appetite loss Asphyxia Aspiration Asthma Atelectasis Bacteraemia Bacterial sepsis Brain contusion Breast abscess Bronchial hyperreactivity Bronchiolitis Bronchopneumonia Cardiac arrest Cellulitis Chest wall abscess Clavicle fracture Colitis Convulsion Corona virus infection Cough Coxsackie viral infection Craniocerebral injury Crohn’s disease Croup infectious Crying (prespecified) Cyanosis Death Decreased appetite (prespecified) Dehydration Device expulsion Diabetic ketoacidosis Diarrhea Drowsiness (prespecified) Duodenal ulcer Dyskinesia Dystonia Eczema herpeticum Erythema Failure to thrive Febrile convulsion Febrile seizures Femur fracture Fever Fibrosarcoma Food intolerance Foreign body Gastritis viral Gastroenteritis Gastroenteritis salmonella Gastroenteritis viral Gastrooesophageal reflux disease Gatroenteritis viral Grade 3 crying abnormal Grade 3 irritability Grade 3 somnolence Groin abscess Haematemesis Hand-foot-and-mouth disease Human herpesvirus 6 infection Hydrocephalus Hydronephrosis Hypoglycaemia Hypotonia Hypoxia Idiopathic thrombocytopenic purpura Infantile apnoeic attack Infection Influenza Injection site induration Injection site tenderness Injection-site bruising Injection-site erythema Injection-site pain (prespecified) Injection-site redness (prespecified) Injection-site swelling (prespecified) Injury intussusception Irritability (prespecified) Kawasaki’s disease Leukocytosis Lymphadenitis Meningitis Meningitis enteroviral Meningitis viral Metabolic acidosis Mortality Movement disorder Nasal congestion Nasopharyngitis Otitis media Periorbital cellulitis Pneumocephalus Pneumonia Pneumonia respiratory syncytial viral Pneumonitis Post concussion syndrome Post procedural infection Pyelonephritis Pyloric stenosis Pyrexia Pyrexia (prespecified) Renal failure acute Respiratory arrest Respiratory distress Respiratory failure Respiratory syncytial virus bronchiolitis Respiratory syncytial virus infection Respiratory tract infection viral Rhinorrhea Roseola Sepsis Sinusitis Skull fracture Skull fracture base Somnolence Staphylococcal infection Subarachnoid haemorrhage Subcutaneous abscess Subdural haemorrhage Sudden infant death syndrome Swelling Tibia fracture Tonic convulsion Type 1 diabetes mellitus Upper respiratory tract infection Urinary tract infection Urine output decreased Viral infection Viral upper respiratory tract infection Vomiting (prespecified) Vulval abscess Wheezing Wound infection staphylococcal
MMR-V (ProQuad)	Acute disseminated encephalomyelitis Anaphylaxis Arthritis/arthralgia Ataxia Bronchitis Bronchopneumonia Conjunctivitis bacterial Cough Death Diarrhoea Diphtheria Electric shock Encephalitis/meningitis/encephalopathy Febrile convulsion Fever Gastroenteritis Gastroenteritis rotavirus Haemophilusinfluenzaetype b Hepatitis B Immune thrombocytopenia purpura Influenza Injection site erythema Injection site pain Injection site swelling Intussusception Kawasaki disease Measles Mumps Nasopharyngitis Otitis media Poliomyelitis type 1 Poliomyelitis type 2 Poliomyelitis type 3 Pyrexia Rash morbilliform Rhinitis Rubella Seizure Skin and subcutaneous tissue disorders Tetanus Upper respiratory tract infection Urinary tract infection Varicella Viral upper respiratory tract infection Vomiting

: Note: N/A—not applicable

The collected adverse events in studies that included children as well as adults are shown in the next table. These studies also contributed to answering KQ2.

Table C.3Assessed adverse events for vaccines in studies enrolling children and adults

Vaccine	Assessed Adverse Events
Diphtheria, tetanus, & acellular pertussis (DTaP)	Acute disseminated encephalomyelitis Optic neuritis Sudden-onset sensorineural hearing loss Transverse myelitis
Tetanus, diphtheria, & acellular pertussis (Tdap; Adacel, Boostrix)	Acute disseminated encephalomyelitis Depression Erythema (prespecified) Fatigue (prespecified) Gastroenteritis Gastrointestinal disorder (prespecified) Headache (prespecified) Nasopharyngitis New onset of chronic illness (prespecified) Optic neuritis Orthostatic intolerance Pain (prespecified) Pyrexia (prespecified) Sudden-onset sensorineural hearing loss Swelling (prespecified) Transverse myelitis
Hepatitis A (HepA; Havrix, Vaqta)	Acute disseminated encephalomyelitis Optic neuritis Sudden-onset sensorineural hearing loss Transverse myelitis
Hepatitis B (HepB; Engerix-B, Recombivax HB)	Acute disseminated encephalomyelitis Optic neuritis Sudden-onset sensorineural hearing loss Transverse myelitis
Haemophilus influenzae type b (Hib; PedvaxHIB, ActHIB, Hiberix)	Acute disseminated encephalomyelitis Optic neuritis Sudden-onset sensorineural hearing loss Transverse myelitis
Human papillomavirus (HPV9; Gardasil 9)	Abdominal pain Abdominal pain lower Abortion induced Abortion spontaneous Abortion spontaneous complete Abortion spontaneous incomplete Abscess jaw Accidental death Acute lymphocytic leukaemia Acute promyelocytic leukaemia Acute psychosis Acute tonsillitis Adenocarcinoma gastric Adenocarcinoma of the cervix Allergy to vaccine Anaemia Anal fistula Anaphylactic reaction Ankle fracture Anorexia and bulimia syndrome Anorexia nervosa Aortic valve incompetence Appendicitis Asthma Asthmatic crisis Atrial fibrillation Axillary vein thrombosis Bartholinitis Benign intracranial hypertension Biliary colic Bipolar disorder Bladder injury Blighted ovum Blood and lymphatic system disorders Brain neoplasm Breast cancer Bronchitis Burns second degree Calculus ureteric Calculus urinary Cardiac disorders Cellulitis Cephalo-pelvic disproportion Cerebral haemorrhage Cervical dysplasia Cervical incompetence Cervix dystocia Cervix haemorrhage uterine Cholangitis Cholecystitis Cholecystitis infective Cholelithiasis Cholestasis of pregnancy Chronic tonsillitis Cleft lip and palate Coeliac disease Colitis Colitis ulcerative Completed suicide Concussion Congenital, familial and genetic disorders Conjunctivitis Craniocerebral injury Crohn’s disease Cystitis haemorrhagic Cytomegalovirus infection Deep vein thrombosis Dengue fever Depression Diabetic coma Diarrhea Diverticulitis Meckel’s Dizziness Dysmenorrhoea Dyspnoea Ear and labyrinth disorders Ectopic pregnancy Endometriosis Enteritis infectious Enterocolitis Ependymoma Epilepsy Facial paresis Fallopian tube cyst False labour Fatigue Femur fracture Fibromyalgia Foetal death Foetal distress syndrome Foetal malposition Foetal malpresentation Foot fracture Foreign body in eye Fracture displacement Gastritis Gastroenteritis Gastroenteritis viral Gastrointestinal disorders Gastrointestinal infection General disorders Gestational diabetes Glioma Gun shot wound Haemorrhagic fever Haemorrhoids Hand fracture Head injury Headache Hepatobiliary disorders Humerus fracture Hydrocephalus Hyperglycaemia Hypersensitivity Hypersomnia Hypoaesthesia Hypovolaemic shock Hypoxic-ischaemic encephalopathy Immune system disorders Infections and infestations Infectious mononucleosis Influenza Inguinal hernia Injection site erythema Injection site pain Injection site pruritus Injection site swelling Injury, poisoning and procedural complications Intracranial venous sinus thrombosis Irritable bowel syndrome Joint dislocation Labour complication Leukaemic infiltration brain Ligament injury Ligament rupture Limb injury Lower limb fracture Lumbar vertebral fracture Lymphadenopathy Major depression Malignant melanoma Malignant palate neoplasm Metabolism and nutrition disorders Migraine Multiple injuries Multiple sclerosis Musculoskeletal and connective tissue disorders Myalgia Nasal cavity cancer Nasal polyps Nasopharyngitis Nausea Neck injury Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nephrolithiasis Nervous system disorders Neuritis Non-cardiac chest pain Oligohydramnios Omental infarction Oropharyngeal pain Orthostatic intolerance Osteoarthritis Ovarian cyst Ovarian neoplasm Pancreatitis acute Paronychia Pelvic inflammatory disease Pelvic pain Pharyngitis Pharyngotonsillitis Pituitary tumour benign Pneumonia Pneumonia aspiration Pneumothorax Poisoning Post abortion infection Post procedural haemorrhage Postoperative wound infection Postural orthostatic tachycardia syndrome Pre-eclampsia Pregnancy, puerperium and perinatal conditions Premature labour Premature rupture of membranes Presyncope Prolonged labour Psychiatric disorders Pubis fracture Pyelonephritis Pyelonephritis acute Pyrexia Renal and urinary disorders Renal colic Renal failure Renal failure acute Reproductive system and breast disorders Respiratory distress Respiratory failure Respiratory papilloma Respiratory, thoracic and mediastinal disorders Road traffic accident Sarcoidosis Sciatica Sensory disturbance Septic shock Skin and subcutaneous tissue disorders Spinal compression fracture Spinal cord injury Spinal cord injury cervical Spondylitic myelopathy Sudden death Suicidal ideation Surgical and medical procedures Syncope Tension headache Thoracic vertebral fracture Thyroid cancer Tibia fracture Tongue injury Tonsillitis Tonsillitis streptococcal Trigeminal nerve disorder Ulna fracture Upper respiratory tract infection Urinary tract infection Urosepsis Urticaria Uterine contractions during pregnancy Vascular disorders Vertigo positional Viral pharyngitis Vocal cord polyp Wound infection
Inactivated polio vaccine (IPV; IPOL)	Acute disseminated encephalomyelitis Optic neuritis Sudden-onset sensorineural hearing loss Transverse myelitis
Inactivated influenza (IIV; Afluria Quadrivalent, Fluarix Quadrivalent, Flulaval Quadrivalent, Fluzone Quadrivalent, Flucelvax Quadrivalent)	N/A
Live attenuated influenza (LAIV; FluMist Quadrivalent)	Any hospitalization Bell’s palsy Encephalitis Guillain-Barré syndrome Hypersensitivity Lower respiratory tract infection Neuritis Respiratory hospitalization (Respiratory hospitalizations included pneumonia, influenza, empyema, chronic obstructive pulmonary disease, chronic bronchitis, emphysema, asthma, bronchiectasis, or other diseases of the respiratory system) Seizures/convulsions Vasculitis Wheezing
Measles, mumps, rubella (MMR; M-M-R II)	Acute disseminated encephalomyelitis Optic neuritis Sudden-onset sensorineural hearing loss Transverse myelitis
Meningococcal, Quadrivalent [MenACWY-D (Menactra), MenACWY-CRM (Menveo), MenACWY-TT (MenQuadfi)]	Abdominal abscess Abortion spontaneous Abortion spontaneous incomplete Abscess/Cellulitis Acute disseminated encephalomyelitis Acute glomerulonephritis Alcoholic seizure Allergic urticaria Allergy to arthropod sting Anaphylaxis Appendicitis Appendicitis perforated Arrhythmia Aseptic Aseptic meningitis Asphyxiation Asthma Autoimmune hemolytic anemia Back pain Bell’s palsy Benign Blood and lymphatic system disorders Brachial neuritis Cancer Cardiac disorders Cerebellar ataxia Chest pain Chills Cholelithiasis Chronic obstructive pulmonary disease Clavicle fracture Complications Congenital Congenital, familial and genetic disorders Constipation Conversion disorder Coronary artery disease Cranial Craniocerebral injury Cyst Dehydration Delirium Depression Diabetes Diabetes mellitus inadequate control Diarrhea Disruptive mood dysregulation disorder Elective Encephalitis Encephalopathy Epilepsy Fatty Febrile Femoral Foot fracture ForeignGastroenteritis Gastroenteritis norovirus Gastrointestinal disorders Gastrointestinal ulcer perforation Gastrooesophageal General disorders Graves’ disease Guillain-Barré syndrome Hashimoto disease Headache Henoch-Schonlein purpura Hepatobiliary disorders Hodgkin’s Horner’s Hydrocephalus Hypersensitivity reactions (including urticaria, angioedema, and anaphylaxis) Hypertension Idiopathic Immune system disorders Infections and infestations Inguinal Injection site erythema Injection site induration Injection site pain Injury, poisoning and procedural complications Intestinal perforation Iridocyclitis (uveitis) ITP Juvenile diabetes mellitus Kyphosis Labyrinthitis Lymphocytic Major depression Malaise Meningococcal disease Metabolism and nutrition disorders Migraine Mortality Multiple sclerosis Musculoskeletal and connective tissue disorders Myalgia Myasthenia gravis Nausea Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nephrolithiasis Nephrotic syndrome Nervous system disorders Neuritis New-onset autoimmune disease (including idiopathic thrombocytopenic purpura, diabetes, arthritis, hemolytic anemia, and collagen-vascular disease) Non-CRC reviewed EOIs Optic neuritis Osteomyelitis Pancreatitis Pancreatitis acute Paraesthesia Pectus Pelvic Pharyngitis Pneumocystosis Pneumonia Pneumonia pseudomonal Pneumothorax Poisoning/Ingestion Pregnancy Presyncope Psychiatric disorders Pulmonary embolism Pyelonephritis Renal and urinary disorders Reproductive system and breast disorders Respiratory, thoracic and mediastinal disorders Rheumatoid arthritis Scoliosis Seizure Sickle Sleep Somatic symptom disorder Splenomegaly Status epilepticus Sudden-onset sensorineural hearing loss Suicidal ideation Suicide attempt Surgical and medical procedures Syncope/LOC Systemic Systemic lupus erythematosus Temporomandibular Testicular Throat tightness Thrombocytopenia Tonsillitis Tooth Transplant Transverse myelitis Trauma Type 2 diabetes mellitus Uterine leiomyoma Vascular disorders
Meningococcal B (MenB; MenB-4C [Bexsero], MenB-FHbp (Trumenba)]	Abdominal abscess Abdominal pain Abortion missed Abortion spontaneous Acute tonsillitis Allergy to arthropod sting Anaphylactic reaction Appendicitis Arthralgia Asthma Attention deficit or hyperactivity disorder Autoimmune thyroiditis Back pain Biliary dyskinesia Breast abscess Bronchitis Carbuncle Cartilage injury Cellulitis Central Nervous System germinoma Clavicle fracture Concussion Constipation Contusion Convulsion Cough Craniocerebral injury Cystitis Demyelination Depression Diabetes mellitus inadequate control Diarrhoea Drug hypersensitivity Duodenal perforation Duodenal ulcer perforation Ectopic pregnancy Enteritis Fall Fatigue Fibula fracture Forearm fracture Gastroenteritis Gastrointestinal viral infection Gun shot wound Head injury Headache Heat stroke Hyperprolactinaemia Hyperventilation Hypothalamo-pituitary disorder Ingrowing nail Injection site erythema Injection site pain Injection site swelling Intentional overdose Intervertebral disc protrusion Jaw fracture Ligament sprain Lower limb fracture Major depression Meningism Meningitis enterococcal Meningitis enteroviral Meningitis viral Menorrhagia Migraine Multiple sclerosis Nasopharyngitis Nausea Neuralgia Neutropenia Oropharyngeal pain Osteochondrosis Overdose Pain in extremity Peritonsillar abscess Pertussis Pharyngitis Pharyngitis streptococcal Pilonidal cyst Pneumonia Postoperative wound infection Psychotic disorder Pyelonephritis Pyrexia Radicular syndrome Rectal abscess Renal tubular necrosis Salpingitis Schizoaffective disorder Sinusitis Snake bite Spinal compression fracture Status asthmaticus Substance abuse Suicidal ideation Tension headache Testicular torsion Tick-borne viral encephalitis Tonsillitis Traumatic intracranial haemorrhage Type 1 diabetes mellitus Upper respiratory tract infection Urinary tract infection Vaccination site pain Viral pharyngitis Vomiting
Pneumococcal polysaccharide vaccine (PPSV23; Pneumovax)	Acute disseminated encephalomyelitis Optic neuritis Sudden-onset sensorineural hearing loss Transverse myelitis
Rotavirus (RV; Rotarix, RotaTeq)	Acute disseminated encephalomyelitis Optic neuritis Sudden-onset sensorineural hearing loss Transverse myelitis
Varicella (VAR; Varivax)	Acute disseminated encephalomyelitis Optic neuritis Sudden-onset sensorineural hearing loss Transverse myelitis
DTap-PepB-IPV (Pediarix)	Acute disseminated encephalomyelitis Optic neuritis Sudden-onset sensorineural hearing loss Transverse myelitis
DTaP-IPV/Hib (Pentacel)	Acute disseminated encephalomyelitis Optic neuritis Sudden-onset sensorineural hearing loss Transverse myelitis
DTaP-IPV (Kinrix, Quadracel)	Acute disseminated encephalomyelitis Optic neuritis Sudden-onset sensorineural hearing loss Transverse myelitis
MMR-V (ProQuad)	Acute disseminated encephalomyelitis Optic neuritis Sudden-onset sensorineural hearing loss Transverse myelitis

: Note: N/A—not applicable

The next table shows assessed adverse events in studies contributing to KQ3.

Table C.4Assessed adverse events in vaccine studies in pregnant women

Vaccine	Assessed Adverse Events
Hepatitis B (HepB; Engerix-B, Recombivax HB)	N/A
Inactivated influenza (IIV; Afluria Quadrivalent, Flucelvax Quadrivalent, Fluarix Quadrivalent, Flulaval Quadrivalent, Fluzone Quadrivalent)	Congenital anomalies Fatigue Fetal death Headache Myalgia Oropharyngeal pain Pain at the injection site Pneumonia Pre-eclampsia Site pruritus Spontaneous abortions Stillbirth
Recombinant influenza (RIV; Flublok Quadrivalent)	N/A
Tetanus, diphtheria, & acellular pertussis (Tdap; Adacel, Boostrix)	5-minute Apgar scores Aaternal neurologic disorders Abdominal discomfort Abdominal distension Abdominal pain Abnormal in fetal heart Abnormal feces Acne Acute appendicitis 19 d after delivery Adenoiditis Adjustment disorder Admission at Neonatal Intensive care Unit (NICU) Allergic reaction Altered mental status Altered state of consciousness Anemia Anemia during pregnancy and purpura Anaphylaxis Ankyloglossia Anomalies of skull and face bones Anophthalmia or microphthalmia Anotia or microtia Antenatal bleeding Any injection site symptom Any systematic symptom Apgar <8 at 5 minutes Aphonia Apnea Arthropod bite Asphyxia Atrial septum and ventricular septum defect Autism spectrum disorder Autonomic disorders Bacterial infection Bacterial sepsis of newborn, specified or unspecified Benign and innocent cardiac murmurs in newborn Bilateral pneumothoracesd Biliary atresia Birth trauma to face Bite Bladder disorder, other specified Bladder exstrophy Body temperature increased Bronchiolitis Bronchiolitis requiring hospitalization Bronchitis Campylobacter gastroenteritis Candida infection Candida nappy rash Candidiasis Cardiomyopathy Cardiomyopathy with biventricular hypertrophy Cardiovascular (Complex chronic condition) Cataracts and other lens defects Cellulitis Cesarean section Change of bowel habit Choking Choking with feeds requiring prolonged hospitalization Chorioamnionitis Chronic hypertension with superimposed pre-eclampsia Cleft lip or cleft palate Central nervous system degeneration/demyelinating Common truncus Tracheoesophageal fistula, esophageal atresia and stenosis Congenital heart anomaly, other specified Congenital pigmentary anomalies of skin Congenital anomalies (major and minor) Congenital chordee Congenital cytomegalovirus infection Congenital hydrocele Congenital hydronephrosis Congenital hypotonia Congenital pneumonia Congenital torticollis Congestive heart failure Conjunctivitis Constipation Cord blood pH values Cough Cranial meningocele Cranial nerve disorders Craniosynostosis Crohn’s disease/colitis Croup infectious Cryptorchism Dacryostenosis acquired Dandy-walker syndrome Decreased appetite Decreased lactation Deep vein thrombosis Dehydration due to oral herpes simplex virus requiring hospitalization Dehydration of newborn Dermatitis Dermatitis atopic Dermatitis diaper Diaphragmatic hernia Diarrhoea Difficulty feeding Drowsiness Dry skin Dyshidrotic eczema Ear infection Ear malformation Eclampsia Eczema Elective termination with/without congenital anomalies Electrolyte anomalies Emotional distress Encephalocele Encephalomyelocele Encephalopathy Enteritis Enterovirus infection Epiphysiolysis Erythema Erythema infectiosum Esophageal atresia w/out tracheoesophageal fistula Exanthema subitum External hydrocephalus Eye discharge Eye infection Eye irritation Eye swelling Impetigo Induced labor Infant death Infantile colic Infantile haemangioma Infection Influenza Influenza like illness Infrequent bowel movements Injection site bruising Injection site erythema Injection site erythema/redness Injection site induration Injection site induration/swelling Injection site mass Injection site nodule Injection site pain Injection site pain, redness, swelling Injection site swelling Injection-site erythema and swelling Injury Interstitial emphysema and related conditions Intestine anomaly, other Intestinal atresia or stenosis Intestinal haemorrhage Intrauterine growth restriction/poor fetal growth Intrauterine hypoxia Intraventricular hemorrhage Intussusception Irritability postvaccinal Jittery baby Lactation disorders (agalactia or hypogalactia) Large for gestational age infants Laryngitis Length of neonatal hospitalization Lethargy, decreased response, facial palsy, attention/sleep disturbance Limb deficiency Live birth with/without congenital anomalies Local and other reactions Local erythema Local heat Longitudinal deficiency phalanges Loss of appetite Low birth weight (LBW; birth weight under 2500 g) Lower limb anomaly, other Major birth defects Major malformations Malaise Malignancy (Complex chronic condition) Maternal cardiomyopathy Maternal death Maternal fever after labor Maternal fever during labor Meconium aspiration syndrome Meningitis Meningoencephalities Metabolic (Complex chronic condition) Microcephalus Microcephaly Mild local pain Milk allergy Mode of delivery Moderate to late preterm Movement disorders Mucous stools Myalgia Myocarditis Nail infection Nasal congestion Nasopharyngitis Nausea and/or vomiting Neonatal asphyxia/hypoxia/respiratory distress Neonatal conjunctivitis and dacryocystitis Neonatal death Neonatal erythema toxicum Neonatal hemorrhage Neonatal hypoxic-ischemic encephalopathy Neonatal jaundice Neonatal pneumonia Neonatal sepsis Neonatal skin infection Nephrolithiasis Neuromuscular (Complex chronic condition) Newborn convulsions NICU admission Obstructive defect of the renal pelvis, other Odynophagia Omphalitis Oral candidiasis Oral fungal infection Oral mucosal erythema Other conditions of integument Other congenital heart disease: septal defects, heterotaxy, partial anomalous pulmonary venous return Other disturbances of temperature regulation of newborn Other fetal malnutrition Other neonatal jaundice Other specified birth trauma Otitis media Otitis media acute Pain in extremity Pain in limb Pallor Pancreatitis 3 mo after delivery Paralytic syndromes Pelvic fracture (motor vehicle crash) Peoteinuria Percaritis Perinatal death Perineal infection Periorbital cellulitis Peripheral coldness Peripheral neuropathy Pertussis illness Pharyngitis Pharyngotonsillitis Phimosis Placental abruption Poor feeding due to gastroesophageal reflux Positional plagiocephaly Posterior urethral valve or prune belly Post-partum endometritis Post-partum hemorrhage Posture abnormal Pre-eclampsia Pre-eclampsia with severe features Preeclampsia/Eclampsia Pregnancy hemorrhage or vaginal hemorrhage Pregnancy-induced hypertension 30 d postvaccination Pregnancy-related hypertension Pre-labor rupture of membranes Premature delivery Premature labor Premature rupture of membranes Premature uterine contraction Presence of birth defect (spina bifida, transposition of great arteries, tetralogy of Fallot, atrioventricular septal defect, cleft palate, cleft lip, rectal and large intestinal atresia/ stenosis, reduction deformity of upper limbs, gastroschisis, or diaphragmatic hernia) Preterm birth (birth before 37 weeks’ gestation) Preterm contractions 33 d postvaccination Preterm delivery Preterm labor Preterm labor requiring hospitalization 18 d after placebo injection Preterm premature rupture of membranes Pulmonary embolism Pulmonary hypertension Pulmonary stenosis Pupils unequal Pyelonephritis Pyloric stenosis Pyrexia Rash Rash erythematous Rash macular Reduction deformities of brain Regurgitation Renal (Complex chronic condition) Renal agenesis or hypoplasia Renal dysplasia Respiratory (Complex chronic condition) Respiratory distress Respiratory distress at birth Vomiting requiring hospitalization 44 d after placebo injection Respiratory distress syndrome Respiratory distress/tachypneac Respiratory rate increase Respiratory syncytial virus bronchiolitis Respiratory tract infection Respiratory tract infection viral Respiratory tract/pneumonia Retained placenta Rhinitis Rhinorrhoea Road traffic accident Respiratory syncytial virus/bronchiolitis Sacral agenesis Sandifer’s syndrome Scalp injury due to birth trauma Seborrhoeic dermatitis Second- or third-degree hypospadias Ostium secundum atrial septal defect Seizure sepsis Septal defect Severe congenital heart disease: single ventricle, tricuspid atresia, Ebstein anomaly, hypoplastic left heart,hypoplastic right heart, common truncus, transposition, atrioventricular septal defects, tetralogy of Fallot, aortic valve atresia or stenosis, coarctation, total anomalous pulmonary venous return, and anomalous coronary artery Skin anomaly, other specified Skull fracture Skull fractured base Small for gestational age (SGA) Somnolence Spina bifida Spinocerebellar disease Spontaneous abortion Still birth Still birth with/ without congenital anomalies Sudden infant death syndrome Superinfection bacterial Syndactyly Syndrome of infant of a diabetic mother Syndrome of infant of mother with gestational diabetes Tachycardia or bradycardia Talipes equinovarus, metatarsus varus, other congenital deformities of feet Teething Thermal burn Thirst Thrombocytopenia Tonsillitis Toothache Torticollis Transient tachypnea of the newborn (TTN); Umbilical hernia Upper limb vessel anomaly Upper respiratory tract infection Urinary tract infection Urticaria Uterine rupture Observation for suspected genetic or metabolic condition Vaccination complication Vaccination site erythema Vaccination site pain Vaccination site swelling Vaginal or intrauterine hemorrhage Varicella Varicella zoster virus infection Venos thromboembolism Ventilation requirement Ventricular septal defect Very low birth weight Vessel puncture site bruise Viral infection Viral rash Viral upper respiratory tract infection Vomiting Wound haemorrhage Wound hematoma after cesarean delivery

: Note: N/A—not applicable

Of note, studies collected information about the presence and absence of a variety of different events and the categories listed in the table are not an indication that the adverse event occurred.

The methods and the reporting of adverse events in the included studies varied widely. The critical appraisal result for all studies is shown in the next figure.

Table C.5Critical appraisal adverse events reporting

Author, Year	Were the Harms PRE-DEFINED Using Standardized or Precise Definitions?	Were SERIOUS Events Precisely Defined?	Were SEVERE Events Precisely Defined?	Were the Number of DEATHS in Each Study Group Specified OR Were the Reason(s) for Not Specifying Them Given?	Was the Mode of Harms Collection Specified as ACTIVE?	Was the Mode of Harms Collection Specified as PASSIVE?	Did the Study Specify WHO Collected the Harms?	Did the Study Specify the TRAINING or BACKGROUND of Who Ascertained the Harms?	Did the Study Specify the TIMING and FREQUENCY of Collection of the Harms?	Did the Author(s) use STANDARD Scale(s) or Checklist(s) for Harms Collection?	Did the Authors Specify if the Harms Reported Encompass ALL the Events Collected or a Selected SAMPLE?	Was the NUMBER of Participants that Withdrew or Were Lost to Followup Specified for Each Study Group?	Was the TOTAL NUMBER of Participants Affected by Harms Specified for Each Study Arm?	Did the Author(s) Specify the NUMBER for each TYPE of Harmful Event for Each Study Group?	Did the Author(s) Specify the Type of Analyses Undertaken for Harms Data?
Abdelnour, 2014⁵¹	0	0	0	2	2	2	2	0	2	0	2	2	2	2	2
Acosta, 2016⁵²	0	1	0	0	0	2	0	0	0	0	2	0	2	2	2
Alberer, 2015⁵³	0	0	2	2	2	2	2	0	0	0	2	2	2	0	2
Alberer, 2015⁵⁴	0	0	2	2	2	2	0	0	2	0	1	2	2	2	0
Amdekar, 2013⁵⁵	0	0	2	2	2	2	2	0	2	0	0	2	2	2	2
Anez, 2020⁵⁶	0	0	2	2	0	0	2	2	0	2	1	2	2	2	2
Baccarini, 2020⁵⁷	2	0	1	0	2	2	2	0	2	0	2	2	2	2	2
Baker, 2019⁵⁸	2	1	1	0	0	2	2	2	2	2	0	0	0	0	2
Baker, 2020⁵⁹	2	1	1	0	0	2	0	0	2	0	0	0	2	2	2
Bart, 2016⁶⁰	2	0	2	2	2	2	2	0	2	0	2	2	2	2	0
Baxter, 2016⁶²	2	0	0	1	0	2	0	0	2	1	0	1	1	1	2
Baxter, 2016⁶³	2	0	0	0	1	2	0	0	2	1	0	1	1	1	2
Baxter, 2017⁶¹	2	1	1	0	0	2	2	2	2	0	0	0	2	2	2
Becerra-Culqui, 2018⁶⁴	2	1	1	0	0	2	2	2	2	0	2	0	2	2	2
Becerra-Culqui, 2020⁶⁵	2	0	1	0	0	2	2	2	0	0	2	2	2	0	2
Beran, 2013⁶⁶	0	0	1	0	2	2	2	0	2	0	2	2	2	2	0
Berenson, 2016⁶⁷	2	1	1	0	0	2	2	2	0	0	0	0	2	2	2
Black, 2010⁶⁸	0	2	2	0	2	2	2	0	2	0	0	2	0	0	0
Block, 2011⁷¹	2	0	1	2	2	2	0	0	2	0	2	2	2	0	2
Block, 2012⁶⁹	2	0	1	2	2	2	0	0	2	0	2	2	0	0	2
Block, 2017⁷⁰	0	2	0	2	2	2	2	0	2	0	2	2	2	2	2
Bonten, 2015⁷²	0	2	1	2	2	2	2	2	2	2	0	2	2	2	2
Briggs-Steinberg, 2019⁷³	0	0	1	0	2	2	2	2	2	0	0	0	2	2	2
Burke, 2020⁷⁴	2	1	1	0	0	2	0	0	2	0	0	0	2	2	2
Carlin, 2013⁷⁵	2	1	1	2	0	2	2	2	2	0	0	0	2	2	2
Caspard, 2018⁷⁶	0	1	1	0	0	2	2	2	2	0	0	0	2	0	2
Chang, 2012⁸⁰	2	1	1	2	0	2	0	0	2	1	0	0	2	2	2
Chang, 2019⁷⁷	0	2	1	2	2	2	2	0	2	0	2	2	2	0	2
Chang, 2020a⁷⁸	2	2	2	2	2	2	0	0	2	1	2	2	2	2	2
Chang, 2020b⁷⁹	0	0	1	2	2	2	0	0	2	0	2	2	2	2	2
Chen, 2012⁸¹	2	0	1	0	2	2	2	2	2	1	0	0	2	2	2
Chlibek, 2013⁸²	0	0	2	0	2	2	2	0	2	0	2	2	2	2	2
Contopoulos-Ioannidis, 2015⁸³	2	0	0	0	0	2	0	0	2	0	0	0	2	2	2
Cowling, 2019⁸⁴	0	0	2	0	2	2	0	0	2	0	0	0	0	0	0
Cunningham, 2016⁸⁵	0	2	2	2	2	2	2	0	2	0	2	2	2	2	2
Cutland, 2018⁸⁶	0	0	1	0	2	2	2	2	2	0	0	2	0	0	0
Dagan, 2013⁸⁷	0	0	1	2	2	2	2	0	2	0	0	2	0	0	2
Daley, 2014⁸⁸	2	0	1	0	0	2	0	0	2	2	0	0	2	2	2
Deichmann, 2015⁸⁹	0	0	0	2	2	2	2	2	2	0	2	2	2	2	2
DeMeo, 2015⁹⁰	0	0	1	2	0	2	0	0	2	0	0	0	0	0	2
DeSilva, 2017⁹¹	2	1	0	0	0	2	0	0	2	0	2	0	2	2	2
Dhingra, 2014⁹²	0	0	0	0	2	2	2	2	2	0	2	2	2	2	2
Dhingra, 2020⁹³	2	2	2	2	2	2	0	0	2	2	2	0	2	2	0
Domachowske, 2013⁹⁴	2	0	1	2	2	2	2	0	2	0	2	0	0	0	2
Donahue, 2019⁹⁵	2	0	1	0	0	2	0	0	2	0	2	0	2	2	2
Duffy, 2016⁹⁶	2	1	1	0	0	2	0	0	2	0	0	0	2	2	2
Dunkle, 2017⁹⁷	0	2	1	2	0	0	2	0	2	1	2	2	2	2	0
Dunkle, 2017⁹⁸	1	2	1	2	0	0	0	0	0	1	2	2	2	2	0
Dynavax, 2006¹⁰⁰	2	2	1	0	2	2	0	0	2	2	2	2	2	2	0
Dynavax, 2015⁹⁹	2	2	2	2	2	2	2	0	2	2	2	2	2	2	2
Eriksson, 2020¹⁰¹	0	0	0	0	2	2	0	0	2	0	0	2	2	2	0
Escolano, 2015¹⁰²	0	1	1	0	0	2	0	0	0	0	0	0	0	0	2
Essink, 2020¹⁰³	2	1	0	2	2	1	2	0	2	2	2	2	2	2	2
Esteves-Jaramillo, 2020¹⁰⁴	0	0	0	0	2	2	0	0	2	0	0	0	0	0	0
Fernandes, 2016¹⁰⁶	2	0	0	2	0	2	2	0	2	0	0	0	2	2	2
Fischer, 2015¹⁰⁷	0	1	0	0	2	2	0	0	2	2	0	2	0	0	0
Fotso Kamdem, 2019¹⁰⁸	2	1	1	2	0	2	2	2	0	2	0	0	2	2	2
Frenck, 2012¹⁰⁹	0	0	0	0	2	2	2	0	2	0	0	2	2	2	2
Frey, 2014¹¹⁰	2	0	0	2	0	0	0	0	2	2	2	2	2	2	2
Garland, 2015¹¹¹	0	2	2	2	2	2	2	0	2	2	2	2	2	2	0
Gasparini, 2014¹¹²	0	0	0	2	2	2	2	0	2	0	2	2	2	2	2
Geier, 2020¹¹³	2	1	1	0	0	2	0	0	2	0	2	1	2	2	2
Gilca, 2018¹¹⁴	0	1	1	0	2	2	2	0	2	0	0	2	0	0	2
Glanz, 2020¹¹⁵	2	0	0	0	0	0	2	2	0	2	0	2	2	2	2
Glover, 2020¹¹⁶	0	2	1	0	2	2	2	0	2	0	2	0	2	2	2
Greenberg, 2013¹¹⁸	2	0	0	2	2	2	2	2	2	2	2	2	2	0	0
Greenberg, 2014¹¹⁷	2	0	1	2	2	2	0	0	2	2	2	2	2	0	2
Greenberg, 2014¹²⁰	0	0	2	2	2	2	2	0	2	0	1	0	0	0	2
Greenberg, 2017¹¹⁹	2	2	2	0	2	2	2	0	2	0	2	2	2	2	2
Griffin, 2018¹²¹	2	0	2	2	0	2	0	0	2	0	2	0	2	2	2
Groome, 2019¹²²	2	1	1	0	0	2	2	2	2	2	2	0	2	2	2
Hall, 2020¹²³	2	1	1	0	0	2	0	0	2	0	0	0	2	2	2
Halperin, 2018¹²⁵	0	0	2	0	2	2	2	0	2	0	2	2	0	0	2
Halperin, 2019¹²⁴	2	2	2	2	2	2	2	0	2	2	2	2	2	2	2
Hansen, 2016¹²⁶	2	0	1	0	0	2	0	0	2	0	0	0	2	2	2
Hansen, 2017¹²⁸	0	0	1	2	0	2	0	0	2	0	0	0	0	2	2
Hansen, 2018¹²⁷	2	1	1	2	0	2	0	0	2	0	0	0	2	2	2
Hartvickson, 2015¹²⁹	2	2	0	2	2	0	2	0	2	0	0	0	0	0	2
Hattori, 2018¹³⁰	0	0	0	2	1	1	0	0	2	1	0	0	0	0	0
Hawken, 2017¹³¹	2	0	0	0	0	2	0	0	2	2	2	0	2	0	2
Heyward, 2013¹³²	2	2	2	2	2	2	2	2	2	2	2	2	2	2	2
Hoffman, 2018¹³³	2	0	0	2	0	2	2	2	2	2	2	0	2	2	2
Huang, 2015¹³⁴	2	1	1	0	0	2	2	2	0	1	0	0	0	0	2
Huang, 2020¹³⁵	2	1	1	0	0	2	0	0	2	0	0	0	2	2	2
Huh, 2017¹³⁶	2	2	2	2	2	2	2	2	2	2	2	2	2	2	2
Hung, 2010¹³⁷	2	0	1	0	2	2	0	0	2	0	0	0	0	0	2
Hviid, 2019¹³⁸	2	0	0	2	0	2	0	0	2	2	2	2	2	0	2
Iwata, 2013¹³⁹	0	0	0	0	0	2	0	0	0	0	0	2	2	2	2
Jackson, 2013¹⁴⁰	2	0	2	2	0	0	0	0	2	1	2	2	2	2	2
Jain, 2015¹⁴¹	2	0	0	2	0	2	2	0	0	0	2	0	2	2	2
Juergens, 2014¹⁴²	2	2	2	0	2	2	2	0	2	2	2	2	2	2	0
Kantso, 2015¹⁴³	0	2	0	0	0	2	0	0	2	2	2	2	2	2	2
Kharbanda, 2016¹⁴⁴	2	0	0	0	0	2	0	0	2	0	0	0	0	0	2
Kieninger, 2013¹⁴⁵	2	2	2	2	2	0	2	2	2	2	2	2	2	2	2
Kim, 2013¹⁴⁶	0	1	1	2	2	2	2	0	2	1	0	2	2	2	2
Kirstein, 2020¹⁴⁷	0	0	1	2	2	2	2	0	2	0	0	2	0	0	2
Klein, 2010¹⁴⁸	2	1	1	0	0	2	0	0	2	0	2	0	2	2	2
Klein, 2015¹⁴⁹	0	0	0	0	0	2	0	0	2	1	1	0	0	0	2
Lal, 2015¹⁵⁰	2	2	2	2	2	0	2	2	2	2	2	2	2	2	2
Langer-Gould, 2014¹⁵¹	2	0	0	0	0	2	0	0	0	2	0	0	2	2	2
Langley, 2013¹⁵²	0	0	1	2	2	2	2	0	2	0	2	2	0	0	2
Langley, 2015¹⁵³	2	2	2	0	2	0	2	2	2	2	1	0	0	0	2
Layton, 2017¹⁵⁴	2	1	1	0	0	2	0	0	2	0	0	0	2	2	2
Layton, 2018¹⁵⁵	2	0	1	0	0	2	0	0	2	0	0	0	0	0	2
Lee, 2014¹⁵⁷	2	2	2	2	2	2	2	0	2	2	2	2	2	2	0
Lee, 2016¹⁵⁶	0	0	2	0	2	2	2	0	2	0	2	2	2	2	2
Leslie, 2017¹⁵⁸	2	1	1	0	0	2	0	0	0	0	0	0	2	2	2
Li, 2014¹⁶¹	0	2	1	2	2	2	0	0	2	0	2	2	2	2	2
Li, 2016¹⁶⁰	2	1	1	0	0	2	0	0	2	0	0	0	0	0	2
Li, 2020¹⁵⁹	2	1	1	2	2	2	0	0	2	0	0	0	0	0	2
Lombardi, 2016¹⁶²	2	2	2	0	2	2	0	0	2	2	2	2	2	2	0
Mallory, 2018a¹⁶⁴	0	0	0	2	2	2	0	0	2	0	2	0	2	2	2
Mallory, 2020¹⁶³	0	2	0	2	2	2	0	0	2	0	2	2	2	0	0
Marechal, 2018¹⁶⁵	2	0	2	2	2	2	0	0	2	2	2	2	2	2	2
Marshall, 2015¹⁶⁶	0	2	1	2	2	2	0	0	2	0	2	2	2	2	2
McClure, 2019¹⁶⁷	2	1	1	0	0	2	0	0	2	0	0	0	2	2	2
McGeoch, 2020¹⁶⁸	2	1	1	0	0	2	0	0	0	0	2	0	2	2	2
Mo, 2017¹⁶⁹	0	0	0	2	1	1	2	0	2	1	0	2	2	0	2
Morgan, 2015¹⁷⁰	0	1	1	2	0	2	0	0	0	0	0	0	2	2	2
Munnoch, 2019¹⁷¹	2	0	2	0	2	2	2	0	2	2	2	0	2	2	0
Munoz, 2014¹⁷²	0	0	0	0	2	2	2	0	2	0	0	2	2	2	2
Naleway, 2018¹⁷³	2	1	1	0	0	2	2	2	2	2	0	0	2	2	2
Nelson, 2013¹⁷⁴	2	0	1	0	0	2	0	0	2	0	1	0	2	2	2
Novartis Vaccines and Diagnostics s.r.l, 2014¹⁰⁵	2	0	0	2	2	2	0	0	2	0	0	2	2	2	0
Oberle, 2020¹⁷⁵	2	0	0	0	0	2	0	0	2	0	2	0	2	0	2
Ochoa-Gondar, 2014¹⁷⁶	2	1	1	2	0	2	2	2	2	1	0	0	2	2	2
Ofori-Anyinam, 2017¹⁷⁷	2	2	2	0	2	2	2	0	2	2	2	2	2	2	2
Ostergaard, 2016¹⁷⁸	2	2	2	2	2	2	2	0	2	1	2	2	2	2	2
Perez, 2017¹⁷⁹	0	0	0	0	2	2	2	2	2	0	0	2	2	2	0
Perez-Vilar, 2019¹⁸⁰	2	1	1	0	0	2	0	0	2	0	0	0	2	2	2
Perrett, 2019¹⁸¹	2	0	1	2	2	2	2	0	2	2	2	2	2	2	2
Petousis-Harris, 2019¹⁸²	2	1	1	2	0	2	0	0	2	0	0	0	2	2	2
Petrecz, 2016¹⁸³	2	2	2	2	2	2	2	0	2	2	2	2	2	2	2
Pfizer, 2007¹⁸⁴	2	1	2	2	2	2	2	2	2	1	1	2	2	2	2
Puig-Barbera, 2007¹⁸⁵	2	1	1	0	0	2	0	0	2	1	0	0	2	2	2
Richmond, 2012¹⁸⁶	0	0	2	0	2	2	2	0	2	0	2	2	2	2	2
Rivera, 2018¹⁸⁷	2	0	1	0	2	1	2	0	2	2	1	2	0	0	0
Rodriguez Weber, 2014¹⁸⁸	0	0	0	2	2	2	0	0	2	0	2	2	2	2	2
Rogers, 2019¹⁸⁹	2	0	0	0	0	2	2	0	2	0	2	0	0	0	0
Salas, 2019¹⁹⁰	2	1	1	0	0	2	0	0	0	0	0	0	0	0	2
Sancovski, 2019¹⁹¹	0	0	1	2	0	2	0	0	0	0	2	0	2	2	2
Sanofi Pasteur, a Sanofi Company, 2019¹⁹²	2	2	0	2	2	2	2	2	2	2	2	2	2	2	0
Santolaya, 2012¹⁹³	0	2	2	2	2	2	2	0	2	0	2	2	2	2	2
Schwarz, 2011¹⁹⁵	0	0	0	2	2	2	2	2	2	0	2	2	2	2	2
Schwarz, 2017¹⁹⁴	2	2	2	2	2	2	0	0	2	1	2	2	2	0	2
Senders, 2016¹⁹⁶	0	0	2	2	2	2	2	0	2	2	0	2	2	2	0
Seo, 2017¹⁹⁷	2	0	0	2	2	2	2	0	2	2	2	2	2	2	2
Shakib, 2013¹⁹⁸	2	1	1	0	0	2	0	0	0	0	0	0	2	2	2
Shimada, 2020¹⁹⁹	0	0	0	0	2	2	2	0	2	0	0	2	0	0	2
Shiramoto, 2015²⁰⁰	2	2	2	2	2	2	0	0	2	2	2	2	2	2	2
Siriwardena, 2014²⁰¹	2	1	1	0	0	2	0	0	2	1	0	0	2	2	2
Song, 2015a²⁰⁴	2	2	2	0	2	2	2	0	2	2	0	2	2	2	0
Song, 2015b²⁰⁵	2	2	2	0	2	2	2	0	2	2	0	2	2	2	0
Song, 2017²⁰²	2	2	2	2	2	2	2	0	2	2	2	2	2	2	2
Song, 2018²⁰³	1	2	2	0	2	2	2	0	2	2	0	2	2	2	0
Stockwell, 2014²⁰⁶	2	1	1	0	2	2	2	2	2	0	0	0	2	2	2
Stockwell, 2017²⁰⁷	2	1	1	0	2	2	2	0	2	0	0	2	2	2	2
Stowe, 2016²⁰⁸	2	1	1	0	0	2	0	0	2	2	2	0	2	2	2
Strezova, 2019²⁰⁹	2	2	2	2	2	2	2	0	2	2	2	2	2	0	0
Svensson, 2018²¹⁰	0	0	0	0	1	1	0	0	0	0	0	2	0	0	0
Tapiero, 2013²¹¹	2	0	1	2	2	2	2	0	2	0	2	2	2	2	2
Tate, 2016²¹³	2	1	1	2	0	2	0	0	2	0	0	0	0	0	2
Tate, 2018²¹²	2	1	1	2	2	2	2	2	2	2	2	0	2	1	2
Thompson, 2019²¹⁴	0	0	0	2	2	2	0	0	2	0	0	2	2	2	2
Timmermann, 2015²¹⁵	0	1	1	0	2	2	2	2	2	2	0	2	2	2	2
Tinoco, 2014²¹⁶	0	0	0	0	2	2	2	0	2	0	1	2	0	0	2
Togashi, 2015²¹⁷	0	0	2	0	2	2	2	0	2	0	2	2	2	2	0
Treanor, 2017²¹⁸	0	0	1	2	2	2	2	0	2	0	2	2	2	2	2
Tregnaghi, 2014²¹⁹	0	0	0	2	2	2	0	0	2	0	0	2	2	2	2
Tseng, 2013²²¹	2	0	0	0	0	2	2	0	2	2	2	2	2	2	2
Tseng, 2017²²⁰	2	0	0	0	0	2	2	2	2	2	2	0	2	2	2
Tseng, 2018²²²	2	0	0	2	0	0	2	0	2	2	2	0	2	2	2
Uhlig, 2014²²³	2	1	1	2	0	2	0	0	2	1	0	0	0	0	2
Uno, 2015²²⁴	2	1	1	0	0	2	0	0	2	2	0	0	0	0	2
Vaarala, 2017²²⁵	1	1	1	0	0	2	0	0	2	1	0	0	2	2	2
Van Damme, 2016²²⁶	2	2	2	2	2	2	2	0	2	1	2	2	2	2	0
Vandecasteele, 2018²²⁷	2	0	0	2	2	2	2	2	2	0	2	2	2	2	0
Vesikari, 2007²²⁹	0	0	0	0	2	2	2	0	2	2	2	2	2	2	0
Vesikari, 2015²²⁸	0	2	2	2	2	2	2	0	2	0	2	2	2	2	0
Vesikari, 2016²³⁰	0	0	0	2	2	2	2	0	2	0	2	2	2	2	2
Vila-Corcoles, 2018²³¹	2	1	1	2	1	1	1	1	2	2	2	0	2	1	2
Villa, 2013²³²	2	2	0	0	0	2	2	2	2	2	0	0	2	2	2
Walter, 2020²³³	2	2	1	2	2	2	2	0	2	0	2	2	2	2	2
Wang, 2016²³⁴	0	0	2	2	2	2	2	0	2	2	2	2	2	2	0
Wang, 2018²³⁵	2	1	1	0	0	2	0	0	2	0	0	0	2	2	2
Yih, 2014²³⁶	2	0	1	0	0	2	0	0	2	2	0	0	2	2	2
Yung, 2015²³⁷	2	1	1	2	0	2	0	0	0	2	2	0	2	2	2
Yung, 2019²³⁸	2	1	1	0	0	2	0	0	2	0	0	0	2	2	2
Zahid, 2012²³⁹	2	1	1	0	0	2	0	0	2	1	0	0	0	0	2

: Table notes: 0 = High risk of bias; 1 = Unsure risk of bias; 2 = Low risk of bias

Bookshelf ID: NBK572042

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Gidengil C, Goetz MB, Maglione M, et al. Safety of Vaccines Used for Routine Immunization in the United States: An Update [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2021 May. (Comparative Effectiveness Review, No. 244.) Appendix C, Results.
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