Table 1. TIV-specific adverse events. 37,621 TIV-induced AE cases were reported.
| Adverse Event | Count | PRR(TIV) | Chi-sq (TIV) |
| AE with an outcome of lab test abnormal | |||
| Electromyogram abnormal | 107 | 4.87 | 248.14 |
| behavior and neurological AE | |||
| Dysarthria | 91 | 2.80 | 75.22 |
| behavior and neurological AE -> movement disorder AE | |||
| Paralysis * | 181 | 2.22 | 105.00 |
| Hyporeflexia (r) | 77 | 2.46 | 56.62 |
| behavior and neurological AE -> sensory capability AE | |||
| Pain | 4516 | 2.12 | 2475.50 |
| Chills | 2286 | 2.78 | 2237.97 |
| Pain in extremity | 2106 | 3.40 | 2944.16 |
| Paraesthesia (r) | 1360 | 2.29 | 858.59 |
| Hypoaesthesia (r) | 1035 | 2.94 | 1114.16 |
| Chest pain | 725 | 2.37 | 492.53 |
| Neck pain | 543 | 2.06 | 260.28 |
| Throat tightness | 449 | 5.20 | 1134.22 |
| Musculoskeletal pain (r) | 432 | 4.00 | 767.24 |
| Palpitations | 267 | 2.70 | 240.23 |
| Feeling cold | 186 | 2.65 | 161.93 |
| Skin burning sensation | 113 | 3.04 | 127.95 |
| Sensation of heaviness | 100 | 2.99 | 109.56 |
| Shoulder pain | 78 | 3.40 | 107.20 |
| Neuralgia (r) | 77 | 2.37 | 52.32 |
| cardiovascular disorder AE | |||
| Heart rate increased | 397 | 2.47 | 297.95 |
| Hypertension | 306 | 2.28 | 189.79 |
| Blood pressure increased | 216 | 4.11 | 398.44 |
| Injection site haematoma | 175 | 4.08 | 318.99 |
| digestive system AE | |||
| Dysphagia | 299 | 2.23 | 175.09 |
| Dry mouth | 75 | 2.68 | 66.49 |
| eye disorder AE | |||
| Eye discharge | 135 | 6.05 | 406.32 |
| Eye irritation | 115 | 4.62 | 249.17 |
| hometostasis AE | |||
| Pharyngeal edema | 256 | 4.30 | 503.52 |
| Swollen tongue | 158 | 4.56 | 336.46 |
| Tongue edema | 105 | 2.51 | 81.09 |
| Local swelling | 88 | 2.05 | 40.97 |
| medical intervention (not under ‘adverse event’) | |||
| Accidental overdose | 83 | 4.59 | 177.98 |
| muscle adverse event | |||
| Muscular weakness (r) | 594 | 2.89 | 614.83 |
| musculoskeletal system AE | |||
| Laryngospasm | 143 | 2.83 | 141.06 |
| nervous system AE | |||
| Guillain-Barre syndrome * | 606 | 4.63 | 1321.69 |
| Mobility decreased (r) | 161 | 3.40 | 221.81 |
| nervous system AE -> mobility decreased AE | |||
| Injected limb mobility decreased (r) | 561 | 4.72 | 1253.55 |
| Joint range of motion decreased (r) | 317 | 4.36 | 635.69 |
| respiratory system AE | |||
| Dyspnea | 2088 | 2.18 | 1180.96 |
| skin adverse event | |||
| Flushing | 403 | 3.00 | 447.05 |
| Eye pruritus | 168 | 9.06 | 754.39 |
| Hot flush | 109 | 3.37 | 147.90 |
Note:
*
= serious adverse event,
(r) = related to serious adverse event.