| 1 | Injury associated with device | FAERS: 42 | | US FAERS |
| 2 | Needle issue | FAERS: 7 | | US FAERS |
| 3 | Hypotension | FAERS: 6 Canada Vigilance: 1 | | Canada Vigilance US FAERS |
| 4 | Medication Error | FAERS: 6 | | US FAERS |
| 5 | Accidental needle stick | FAERS: 5 | | OFFSIDES US FAERS |
| 6 | Device malfunction | FAERS: 5 | | OFFSIDES US FAERS |
| 7 | Dizziness | FAERS: 5 | | US FAERS |
| 8 | Respiratory Failure | FAERS: 5 Canada Vigilance: 1 | | Canada Vigilance OFFSIDES US FAERS |
| 9 | Unresponsive to stimuli | FAERS: 5 | | OFFSIDES US FAERS |
| 10 | Chills | FAERS: 4 | | US FAERS |
| 11 | Flushing | FAERS: 4 Canada Vigilance: 1 | | Canada Vigilance US FAERS |
| 12 | Hypoxia | FAERS: 4 | | OFFSIDES US FAERS |
| 13 | Tremor | FAERS: 4 | | US FAERS |
| 14 | Back Pain | FAERS: 3 Canada Vigilance: 1 | | Canada Vigilance US FAERS |
| 15 | Chest Pain | FAERS: 3 | | OFFSIDES US FAERS |
| 16 | Cyanosis | FAERS: 3 Canada Vigilance: 1 | | Canada Vigilance US FAERS |
| 17 | Erythema | FAERS: 3 | | US FAERS |
| 18 | Tachycardia | FAERS: 3 | | US FAERS |
| 19 | Anaphylactic shock | FAERS: 2 | | US FAERS |
| 20 | Asthenia | FAERS: 2 | | OFFSIDES US FAERS |
| 21 | Chest discomfort | FAERS: 2 Canada Vigilance: 1 | | Canada Vigilance US FAERS |
| 22 | Circumstance or information capable of leading to medication error | FAERS: 2 | | OFFSIDES US FAERS |
| 23 | Device breakage | FAERS: 2 | | OFFSIDES US FAERS |
| 24 | Drug dispensing error | FAERS: 2 | | US FAERS |
| 25 | Embolism | FAERS: 2 | | US FAERS |
| 26 | Exposure via contaminated device | FAERS: 2 | | US FAERS |
| 27 | Medical device complication | FAERS: 2 | | US FAERS |
| 28 | Nausea | FAERS: 2 | | OFFSIDES US FAERS |
| 29 | Pain | FAERS: 2 | | OFFSIDES US FAERS |
| 30 | Pharmaceutical product complaint | FAERS: 2 | | US FAERS |
| 31 | Product packaging issue | FAERS: 2 | | US FAERS |
| 32 | Product quality issue | FAERS: 2 | | US FAERS |
| 33 | Pulmonary Embolism | FAERS: 2 | | US FAERS |
| 34 | Vomiting | FAERS: 2 | | US FAERS |
| 35 | jaundice | FAERS: 2 | | US FAERS |
| 36 | Abdominal Abscess | FAERS: 1 | | US FAERS |
| 37 | Abdominal Pain | FAERS: 1 | | OFFSIDES US FAERS |
| 38 | Abdominal wound dehiscence | FAERS: 1 | | US FAERS |
| 39 | Accidental exposure to product | FAERS: 1 | | US FAERS |
| 40 | Acute myocardial infarction | FAERS: 1 | | US FAERS |
| 41 | Agitation | FAERS: 1 | | US FAERS |
| 42 | Atrial Fibrillation | FAERS: 1 Canada Vigilance: 1 | | Canada Vigilance US FAERS |
| 43 | Bradycardia | FAERS: 1 | | OFFSIDES US FAERS |
| 44 | Cerebrovascular accident | FAERS: 1 | | US FAERS |
| 45 | Crying | FAERS: 1 | | US FAERS |
| 46 | Deep Vein Thrombosis | FAERS: 1 | | US FAERS |
| 47 | Depressed Level of Consciousness | FAERS: 1 | | US FAERS |
| 48 | Device use error | FAERS: 1 | | US FAERS |
| 49 | Diverticulum | FAERS: 1 | | OFFSIDES US FAERS |
| 50 | Drug administration error | FAERS: 1 | | US FAERS |
| 51 | Drug ineffective | FAERS: 1 | | US FAERS |
| 52 | Electromechanical dissociation | FAERS: 1 | | OFFSIDES US FAERS |
| 53 | Feeling Cold | FAERS: 1 | | OFFSIDES US FAERS |
| 54 | Feeling abnormal | FAERS: 1 | | US FAERS |
| 55 | Foreign body trauma | FAERS: 1 | | US FAERS |
| 56 | General physical health deterioration | FAERS: 1 | | OFFSIDES US FAERS |
| 57 | Iatrogenic injury | FAERS: 1 | | US FAERS |
| 58 | Incorrect dose administered | FAERS: 1 | | US FAERS |
| 59 | Incorrect drug administration rate | FAERS: 1 Canada Vigilance: 1 | | Canada Vigilance US FAERS |
| 60 | Incorrect route of product administration | FAERS: 1 Canada Vigilance: 1 | | Canada Vigilance US FAERS |
| 61 | Injection Site Reaction | FAERS: 1 Canada Vigilance: 1 | | Canada Vigilance US FAERS |
| 62 | Intercepted medication error | FAERS: 1 | | US FAERS |
| 63 | Laceration | FAERS: 1 | | OFFSIDES US FAERS |
| 64 | Limb injury | FAERS: 1 | | OFFSIDES US FAERS |
| 65 | Lip swelling | FAERS: 1 | | US FAERS |
| 66 | Mental status changes | FAERS: 1 | | OFFSIDES US FAERS |
| 67 | Neck Pain | FAERS: 1 | | US FAERS |
| 68 | No adverse event | FAERS: 1 | | US FAERS |
| 69 | Occult blood positive | FAERS: 1 | | US FAERS |
| 70 | Occupational exposure to product | FAERS: 1 | | US FAERS |
| 71 | Product container seal issue | FAERS: 1 | | US FAERS |
| 72 | Product label confusion | FAERS: 1 | | US FAERS |
| 73 | Product label issue | FAERS: 1 | | US FAERS |
| 74 | Product packaging confusion | FAERS: 1 | | US FAERS |
| 75 | Product substitution issue | FAERS: 1 | | US FAERS |
| 76 | Pruritus | FAERS: 1 | | US FAERS |
| 77 | Rash erythematous | FAERS: 1 | | US FAERS |
| 78 | Reaction to drug excipients | FAERS: 1 | | US FAERS |
| 79 | Respiratory arrest | FAERS: 1 | | US FAERS |
| 80 | Secretion discharge | FAERS: 1 | | US FAERS |
| 81 | Sepsis | FAERS: 1 | | US FAERS |
| 82 | Skin laceration | FAERS: 1 | | US FAERS |
| 83 | Syringe issue | FAERS: 1 | | US FAERS |
| 84 | Tongue biting | FAERS: 1 | | US FAERS |
| 85 | Tooth Extraction | FAERS: 1 | | OFFSIDES US FAERS |
| 86 | Unevaluable event | FAERS: 1 | | US FAERS |
| 87 | Vascular stent thrombosis | FAERS: 1 | | US FAERS |
| 88 | Ventricular Fibrillation | FAERS: 1 | | OFFSIDES US FAERS |
| 89 | Wrong patient received medication | FAERS: 1 | | US FAERS |
| 90 | Wrong technique in drug usage process | FAERS: 1 | | US FAERS |
| 91 | Abdominal discomfort | | | OFFSIDES |
| 92 | Abnormal vision | | | OFFSIDES |
| 93 | Abscess | | | OFFSIDES |
| 94 | Acidosis | | | OFFSIDES |
| 95 | Acute Coronary Syndrome | | | OFFSIDES |
| 96 | Acute left ventricular failure | | | OFFSIDES |
| 97 | Acute otitis media | | | OFFSIDES |
| 98 | Acute respiratory failure | | | OFFSIDES |
| 99 | Adenoma | | | OFFSIDES |
| 100 | Alanine Aminotransferase Increased | | | OFFSIDES |
| 101 | Alkalosis | | | OFFSIDES |
| 102 | Alveolitis | | | OFFSIDES |
| 103 | Ammonia increased | | | OFFSIDES |
| 104 | Anorexia | | | OFFSIDES |
| 105 | Antibiotic level above therapeutic | | | OFFSIDES |
| 106 | Antithrombin III decreased | | | OFFSIDES |
| 107 | Anuria | | | OFFSIDES |
| 108 | Anxiety | | | OFFSIDES |
| 109 | Aphakia | | | OFFSIDES |
| 110 | Aphthous Stomatitis | | | OFFSIDES |
| 111 | Apolipoprotein increased | | | OFFSIDES |
| 112 | Application site rash | | | OFFSIDES |
| 113 | Application site vesicles | | | OFFSIDES |
| 114 | Arteriosclerosis | | | OFFSIDES |
| 115 | Ascites | | | OFFSIDES |
| 116 | Asphyxia | | | OFFSIDES |
| 117 | Asterixis | | | OFFSIDES |
| 118 | Atelectasis | | | OFFSIDES |
| 119 | Atrial Flutter | | | OFFSIDES |
| 120 | Atrial tachycardia | | | OFFSIDES |
| 121 | Autoimmune hepatitis | | | OFFSIDES |
| 122 | Autologous bone marrow transplantation therapy | | | OFFSIDES |
| 123 | Automatism | | | OFFSIDES |
| 124 | Basal ganglion degeneration | | | OFFSIDES |
| 125 | Biopsy liver abnormal | | | OFFSIDES |
| 126 | Blood Glucose | | | OFFSIDES |
| 127 | Blood albumin decreased | | | OFFSIDES |
| 128 | Blood alkaline phosphatase increased | | | OFFSIDES |
| 129 | Blood amylase increased | | | OFFSIDES |
| 130 | Blood cholinesterase decreased | | | OFFSIDES |
| 131 | Blood creatine phosphokinase increased | | | OFFSIDES |
| 132 | Blood creatinine decreased | | | OFFSIDES |
| 133 | Blood creatinine increased | | | OFFSIDES |
| 134 | Blood fibrinogen increased | | | OFFSIDES |
| 135 | Blood gases abnormal | | | OFFSIDES |
| 136 | Blood magnesium decreased | | | OFFSIDES |
| 137 | Blood potassium increased | | | OFFSIDES |
| 138 | Blood product transfusion dependent | | | OFFSIDES |
| 139 | Blood sodium increased | | | OFFSIDES |
| 140 | Blood sodium | | | OFFSIDES |
| 141 | Blood urea increased | | | OFFSIDES |
| 142 | Body Temperature | | | OFFSIDES |
| 143 | Bone lesion | | | OFFSIDES |
| 144 | Bone pain | | | OFFSIDES |
| 145 | Brain natriuretic peptide increased | | | OFFSIDES |
| 146 | Bronchoalveolar Lavage | | | OFFSIDES |
| 147 | Bronchopneumonia | | | OFFSIDES |
| 148 | Calcinosis | | 21193197 | CTD |
| 149 | Candidiasis of vagina | | | OFFSIDES |
| 150 | Candiduria | | | OFFSIDES |
| 151 | Cardiac Arrest | Canada Vigilance: 1 | | Canada Vigilance |
| 152 | Cardiac enzymes increased | | | OFFSIDES |
| 153 | Cardioactive drug level increased | | | OFFSIDES |
| 154 | Cataract operation | | | OFFSIDES |
| 155 | Catheter related infection | | | OFFSIDES |
| 156 | Catheter sepsis | | | OFFSIDES |
| 157 | Catheter site erythema | | | OFFSIDES |
| 158 | Catheter site pain | | | OFFSIDES |
| 159 | Cellulitis | | | OFFSIDES |
| 160 | Central Nervous System Infection | | | OFFSIDES |
| 161 | Cerebral Hemorrhage | | 1723166 | CTD |
| 162 | Cerebral Palsy | | | OFFSIDES |
| 163 | Cerebral artery occlusion | | | OFFSIDES |
| 164 | Cerebral ventricle dilatation | | | OFFSIDES |
| 165 | Choking sensation | | | OFFSIDES |
| 166 | Cholangiolitis | | | OFFSIDES |
| 167 | Cirrhosis | | | OFFSIDES |
| 168 | Cleft Palate | | | OFFSIDES |
| 169 | Clonus | | | OFFSIDES |
| 170 | Colitis | | | OFFSIDES |
| 171 | Complications of transplant surgery | | | OFFSIDES |
| 172 | Confabulation | | | OFFSIDES |
| 173 | Congenital nystagmus | | | OFFSIDES |
| 174 | Congenital tricuspid valve incompetence | | | OFFSIDES |
| 175 | Culture positive | | | OFFSIDES |
| 176 | Culture wound positive | | | OFFSIDES |
| 177 | Cyst | | | OFFSIDES |
| 178 | Cytolytic hepatitis | | | OFFSIDES |
| 179 | Cytomegalovirus test | | | OFFSIDES |
| 180 | Delayed sleep phase | | | OFFSIDES |
| 181 | Delusional disorder, unspecified type | | | OFFSIDES |
| 182 | Demyelination | | | OFFSIDES |
| 183 | Depressed mood | | | OFFSIDES |
| 184 | Device Failure | | | OFFSIDES |
| 185 | Device related infection | | | OFFSIDES |
| 186 | Diarrhea | | | OFFSIDES |
| 187 | Dilatation intrahepatic duct acquired | | | OFFSIDES |
| 188 | Disabled relative | | | OFFSIDES |
| 189 | Disease Progression | | | OFFSIDES |
| 190 | Disseminated Intravascular Coagulation | | | OFFSIDES |
| 191 | Distal intestinal obstruction syndrome | | | OFFSIDES |
| 192 | Diverticulitis | | | OFFSIDES |
| 193 | Drug Eruptions | | 8936071 | CTD |
| 194 | Drug exposure during pregnancy | | | OFFSIDES |
| 195 | Drug toxicity | | | OFFSIDES |
| 196 | Dyspnoea exacerbated | | | OFFSIDES |
| 197 | Economic problem | | | OFFSIDES |
| 198 | Eczema | | 8936071 | CTD |
| 199 | Endodontic procedure | | | OFFSIDES |
| 200 | Enterococcal infection | | | OFFSIDES |
| 201 | Enterococcal sepsis | | | OFFSIDES |
| 202 | Epilepsy | | | OFFSIDES |
| 203 | Epistaxis | | | OFFSIDES |
| 204 | Erosive gastritis | | | OFFSIDES |
| 205 | Escherichia urinary tract infection | | | OFFSIDES |
| 206 | Failure to Thrive | | | OFFSIDES |
| 207 | Fatigue | | | OFFSIDES |
| 208 | Fatty Liver | | | OFFSIDES |
| 209 | Febrile Neutropenia | | | OFFSIDES |
| 210 | Fluid imbalance | | | OFFSIDES |
| 211 | Fluid overload | | | OFFSIDES |
| 212 | Fracture treatment | | | OFFSIDES |
| 213 | Gamma-Glutamyltransferase Increased | | | OFFSIDES |
| 214 | Gangrene | | | OFFSIDES |
| 215 | Gastroenteritis | | | OFFSIDES |
| 216 | General physical condition | | | OFFSIDES |
| 217 | Granulocytosis | | | OFFSIDES |
| 218 | Granuloma | | | OFFSIDES |
| 219 | Hematoma | | 1723166 | CTD |
| 220 | Hemiparesis | | | OFFSIDES |
| 221 | Heparin-induced thrombocytopenia | | | OFFSIDES |
| 222 | Hepatic necrosis | | | OFFSIDES |
| 223 | Hepatitis B positive | | | OFFSIDES |
| 224 | Hepatitis | | | OFFSIDES |
| 225 | Hepatotoxicity | | | OFFSIDES |
| 226 | Hydrocephalus | | | OFFSIDES |
| 227 | Hypercreatininaemia | | | OFFSIDES |
| 228 | Hypertensive cardiomyopathy | | | OFFSIDES |
| 229 | Hypertensive heart disease | | | OFFSIDES |
| 230 | Hypothalamo-pituitary disorder | | | OFFSIDES |
| 231 | Immunosuppression | | | OFFSIDES |
| 232 | Impaired gastric emptying | | | OFFSIDES |
| 233 | Implant site infection | | | OFFSIDES |
| 234 | Infantile apnoeic attack | | | OFFSIDES |
| 235 | Injection site pain | Canada Vigilance: 1 | | Canada Vigilance |
| 236 | Inspiratory capacity decreased | | | OFFSIDES |
| 237 | Intermittent Claudication | | | OFFSIDES |
| 238 | Intervertebral Disc Degeneration | | | OFFSIDES |
| 239 | Intestinal Perforation | | | OFFSIDES |
| 240 | Iridocele | | | OFFSIDES |
| 241 | Jugular vein distension | | | OFFSIDES |
| 242 | Kidney Failure | | | OFFSIDES |
| 243 | Lethargy | | | OFFSIDES |
| 244 | Leukopenia neonatal | | | OFFSIDES |
| 245 | Lipase | | | OFFSIDES |
| 246 | Lower respiratory tract infection fungal | | | OFFSIDES |
| 247 | Lower respiratory tract infection viral | | | OFFSIDES |
| 248 | Lung consolidation | | | OFFSIDES |
| 249 | Lung infection pseudomonal | | | OFFSIDES |
| 250 | Malabsorption | | | OFFSIDES |
| 251 | Mental Retardation | | | OFFSIDES |
| 252 | Metabolic acidosis | | | OFFSIDES |
| 253 | Metastases to abdominal cavity | | | OFFSIDES |
| 254 | Metastatic Renal Cell Carcinoma | | | OFFSIDES |
| 255 | Metastatic pain | | | OFFSIDES |
| 256 | Microlithiasis | | | OFFSIDES |
| 257 | Musculoskeletal discomfort | | | OFFSIDES |
| 258 | Myoglobin blood increased | | | OFFSIDES |
| 259 | Myoglobin urine present | | | OFFSIDES |
| 260 | Neonatal hypotension | | | OFFSIDES |
| 261 | Neuroma | | | OFFSIDES |
| 262 | Ocular icterus | | | OFFSIDES |
| 263 | Oliguria | | | OFFSIDES |
| 264 | Orthopnea | | | OFFSIDES |
| 265 | Osteomyelitis | | | OFFSIDES |
| 266 | PCO2 decreased | | | OFFSIDES |
| 267 | Pain of skin | | | OFFSIDES |
| 268 | Pallor | | | OFFSIDES |
| 269 | Pancreatitis | | | OFFSIDES |
| 270 | Pericardial effusion | | | OFFSIDES |
| 271 | Pilonidal cyst congenital | | | OFFSIDES |
| 272 | Pneumopericardium | | | OFFSIDES |
| 273 | Pneumothorax | | | OFFSIDES |
| 274 | Portal Hypertension | | | OFFSIDES |
| 275 | Portal hypertensive gastropathy | | | OFFSIDES |
| 276 | Post procedural complication | | | OFFSIDES |
| 277 | Post procedural pain | | | OFFSIDES |
| 278 | Procedural complication | | | OFFSIDES |
| 279 | Productive Cough | | | OFFSIDES |
| 280 | Protein total decreased | | | OFFSIDES |
| 281 | Protein total increased | | | OFFSIDES |
| 282 | Pseudobulbar Palsy | | | OFFSIDES |
| 283 | Pulmonary Eosinophilia | | | OFFSIDES |
| 284 | Pulmonary Hypertension | | | OFFSIDES |
| 285 | Pulmonary congestion | | | OFFSIDES |
| 286 | Pulmonary function test decreased | | | OFFSIDES |
| 287 | Pulmonary thrombosis | | | OFFSIDES |
| 288 | Red blood cell schistocytes present | | | OFFSIDES |
| 289 | Refusal of treatment by relative | | | OFFSIDES |
| 290 | Renal tubular acidosis | | | OFFSIDES |
| 291 | Renal tubular necrosis | | | OFFSIDES |
| 292 | Rhabdomyolysis | | | OFFSIDES |
| 293 | Scotoma | | | OFFSIDES |
| 294 | Septic Shock | | | OFFSIDES |
| 295 | Serratia sepsis | | | OFFSIDES |
| 296 | Shoulder Pain | | | OFFSIDES |
| 297 | Sick Sinus Syndrome | | | OFFSIDES |
| 298 | Skin lesion | | | OFFSIDES |
| 299 | Skin necrosis | | | OFFSIDES |
| 300 | Skin toxicity | | | OFFSIDES |
| 301 | Spinal column stenosis | | | OFFSIDES |
| 302 | Splenic Infarction | | | OFFSIDES |
| 303 | Spondylolisthesis | | | OFFSIDES |
| 304 | Sputum culture positive | | | OFFSIDES |
| 305 | Stem cell transplant | | | OFFSIDES |
| 306 | Stevens-Johnson Syndrome | | | OFFSIDES |
| 307 | Stridor | | | OFFSIDES |
| 308 | Synovial Cyst | | | OFFSIDES |
| 309 | Tendinitis | | | OFFSIDES |
| 310 | Thalamic infarction | | | OFFSIDES |
| 311 | Thrombectomy | | | OFFSIDES |
| 312 | Toxoplasmosis | | | OFFSIDES |
| 313 | Tracheobronchitis | | | OFFSIDES |
| 314 | Troponin I increased | | | OFFSIDES |
| 315 | Troponin increased | | | OFFSIDES |
| 316 | Unequal Limb Length | | | OFFSIDES |
| 317 | Urinary tract infection enterococcal | | | OFFSIDES |
| 318 | Vanishing bile duct syndrome | | | OFFSIDES |
| 319 | Vascular calcification | | 23990204 27412937 | CTD |
| 320 | Venoocclusive disease | | | OFFSIDES |
| 321 | Ventricular hypokinesia | | | OFFSIDES |
| 322 | Vitamin K Deficiency | | | OFFSIDES |
| 323 | White blood cell count abnormal | | | OFFSIDES |
| 324 | Wound infection fungal | | | OFFSIDES |
| 325 | jejunitis | | | OFFSIDES |