Table 2. Engerix-B-specific adverse events.
| Adverse Event | Count | PRR | Chi-square |
|---|---|---|---|
| Behavioral and neurological AE | |||
| Balance disorder | 80 | 2.55 | 71.43 |
| Clumsiness | 9 | 2.48 | 7.52 |
| Depression | 43 | 2.10 | 23.72 |
| Difficulty in walking | 45 | 3.61 | 78.38 |
| Disturbance in attention | 64 | 2.99 | 79.60 |
| Dysgraphia | 13 | 3.45 | 20.82 |
| Hemiparesis | 35 | 3.29 | 51.85 |
| Fibromyalgia | 35 | 5.09 | 102.34 |
| Memory impairment | 57 | 3.90 | 112.51 |
| Motor dysfunction | 29 | 4.82 | 78.61 |
| Muscle contractions involuntary | 14 | 2.39 | 10.66 |
| Paresis | 22 | 4.13 | 47.45 |
| Vertigo | 78 | 2.31 | 55.36 |
| Sensory disturbance | 69 | 3.81 | 131.51 |
| Brain AE | |||
| Cerebellar syndrome | 38 | 17.51 | 413.55 |
| Digestive system AE | |||
| Tongue disorder | 14 | 2.14 | 8.12 |
| Ear AE | |||
| Vestibular disorder | 11 | 10.88 | 77.85 |
| Eye AE | |||
| Double vision | 49 | 3.90 | 96.90 |
| Dry eye | 9 | 2.37 | 6.74 |
| Eye disorder | 27 | 2.03 | 13.44 |
| Nystagmus | 22 | 4.00 | 45.14 |
| Scotoma | 8 | 6.49 | 32.03 |
| Visual acuity reduced | 50 | 5.53 | 163.52 |
| Visual disturbance | 48 | 3.87 | 93.59 |
| Hepatobiliary or pancreatic AE | |||
| Hepatomegaly* | 9 | 2.57 | 8.13 |
| Jaundice | 20 | 2.16 | 11.82 |
| Liver disorder | 9 | 2.66 | 8.79 |
| Immune system AE | |||
| Hepatitis B* | 8 | 2.15 | 4.67 |
| Multiple sclerosis* | 231 | 15.77 | 2312.90 |
| Osteoarthritis* | 14 | 3.48 | 22.85 |
| Polyarthritis* | 16 | 3.96 | 32.25 |
| Psoriasis* | 15 | 5.29 | 46.20 |
| Rheumatoid arthritis* | 37 | 4.18 | 81.34 |
| Systemic lupus erythematosus* | 28 | 4.14 | 60.72 |
| Vasculitis* | 25 | 2.87 | 28.56 |
| Central nervous system inflammation | 9 | 6.19 | 33.97 |
| Hepatitis | 40 | 6.82 | 170.24 |
| Multiple sclerosis relapse | 8 | 8.77 | 45.29 |
| Investigation result abnormal AE | |||
| Blood immunoglobulin A level increased | 10 | 7.80 | 49.73 |
| Blood bilirubin level increased | 22 | 2.20 | 13.75 |
| Gamma-glutamyltransferase level increased | 20 | 2.58 | 18.28 |
| Transaminase level increased | 16 | 4.38 | 37.76 |
| Metabolism, endocrine or exocrine system AE | |||
| Hypothyroidism | 11 | 3.08 | 14.35 |
| Musculoskeletal or connective tissue AE | |||
| Fasciitis | 82 | 19.45 | 971.39 |
| Fibrosis tendinous | 44 | 25.13 | 629.96 |
| Myofascitis | 46 | 16.08 | 466.37 |
| Muscular atrophy | 38 | 6.61 | 155.96 |
| Muscle disorder | 34 | 7.04 | 150.22 |
| Tendonitis | 16 | 2.28 | 10.87 |
| Nervous system AE | |||
| Myelitis* | 14 | 3.19 | 19.54 |
| Carpal tunnel syndrome | 10 | 3.50 | 16.42 |
| Central nervous system lesion | 13 | 3.18 | 18.00 |
| Demyelination | 90 | 8.75 | 509.95 |
| Dysesthesia | 10 | 5.71 | 34.09 |
| Extrapyramidal disorder | 11 | 18.59 | 125.56 |
| Formication | 16 | 4.57 | 40.14 |
| Hyperreflexia | 22 | 4.67 | 57.00 |
| Myelopathy | 8 | 8.54 | 44.00 |
| Neuritis | 12 | 2.86 | 13.60 |
| Neuropathy | 26 | 5.22 | 78.70 |
| Optic neuritis | 46 | 5.79 | 160.01 |
| Optic neuritis retrobulbar | 20 | 30.04 | 322.66 |
| Polyneuropathy | 16 | 3.33 | 24.10 |
| Pyramidal tract syndrome | 14 | 33.40 | 241.34 |
| Urinary system AE | |||
| Dysuria | 27 | 3.40 | 42.31 |
| Micturition disorder | 11 | 20.28 | 134.43 |
| Proteinuria | 10 | 2.20 | 6.25 |
| Urgent urination | 13 | 6.06 | 47.82 |
| Urinary tract obstruction | 11 | 14.87 | 104.16 |
*Serious adverse event (SAE).