Eudravigilance C-19 - Janssen
Liste des effets indésirables (uniquement ceux qui apparaissent dans plus de 50 cas graves)
PT |
Décès 1157 (%) |
Mise en jeu du pronostic vital 1508 (%) |
Invalidité ou incapacité 1234 (%) |
Anomalies congénitales 8 (%) |
Hospitalisation 3768 (%) |
Médicalement significatif 11195 (%) |
Cas Graves 18870 (%) |
|---|---|---|---|---|---|---|---|
| Abdominal discomfort | 4 (0.35) | 2 (0.13) | 9 (0.73) | 0 | 15 (0.40) | 33 (0.29) | 64 (0.34) |
| Abdominal pain | 19 (1.64) | 38 (2.52) | 26 (2.11) | 0 | 70 (1.86) | 72 (0.64) | 225 (1.19) |
| Abdominal pain upper | 7 (0.61) | 13 (0.86) | 11 (0.89) | 0 | 57 (1.51) | 78 (0.70) | 166 (0.88) |
| Acute kidney injury | 20 (1.73) | 10 (0.66) | 0 | 0 | 33 (0.88) | 3 (0.03) | 68 (0.36) |
| Acute myocardial infarction | 19 (1.64) | 37 (2.45) | 2 (0.16) | 0 | 46 (1.22) | 5 (0.04) | 111 (0.59) |
| Acute respiratory failure | 20 (1.73) | 24 (1.59) | 0 | 0 | 24 (0.64) | 0 | 68 (0.36) |
| Adverse event | 2 (0.17) | 2 (0.13) | 2 (0.16) | 0 | 85 (2.26) | 49 (0.44) | 140 (0.74) |
| Ageusia | 8 (0.69) | 0 | 6 (0.49) | 0 | 18 (0.48) | 33 (0.29) | 67 (0.36) |
| Amnesia | 2 (0.17) | 5 (0.33) | 4 (0.32) | 0 | 20 (0.53) | 31 (0.28) | 62 (0.33) |
| Anaphylactic reaction | 4 (0.35) | 27 (1.79) | 1 (0.08) | 0 | 21 (0.56) | 74 (0.66) | 128 (0.68) |
| Anaphylactic shock | 2 (0.17) | 16 (1.06) | 0 | 0 | 13 (0.35) | 20 (0.18) | 51 (0.27) |
| Angina pectoris | 1 (0.09) | 4 (0.27) | 3 (0.24) | 0 | 13 (0.35) | 45 (0.40) | 67 (0.36) |
| Angiogram | 1 (0.09) | 30 (1.99) | 8 (0.65) | 0 | 19 (0.50) | 18 (0.16) | 76 (0.40) |
| Angiogram cerebral abnormal | 7 (0.61) | 27 (1.79) | 7 (0.57) | 0 | 26 (0.69) | 1 (0.01) | 68 (0.36) |
| Angiogram pulmonary abnormal | 6 (0.52) | 62 (4.11) | 1 (0.08) | 0 | 57 (1.51) | 3 (0.03) | 129 (0.68) |
| Anticoagulant therapy | 19 (1.64) | 145 (9.62) | 12 (0.97) | 0 | 109 (2.89) | 17 (0.15) | 302 (1.60) |
| Anxiety | 1 (0.09) | 11 (0.73) | 8 (0.65) | 0 | 42 (1.11) | 67 (0.60) | 129 (0.68) |
| Aphasia | 8 (0.69) | 18 (1.19) | 13 (1.05) | 0 | 33 (0.88) | 14 (0.13) | 86 (0.46) |
| Arrhythmia | 7 (0.61) | 5 (0.33) | 3 (0.24) | 0 | 25 (0.66) | 47 (0.42) | 87 (0.46) |
| Arthralgia | 9 (0.78) | 36 (2.39) | 237 (19.21) | 0 | 110 (2.92) | 275 (2.46) | 668 (3.54) |
| Asthenia | 65 (5.62) | 60 (3.98) | 75 (6.08) | 0 | 207 (5.49) | 267 (2.38) | 681 (3.61) |
| Atrial fibrillation | 11 (0.95) | 23 (1.53) | 2 (0.16) | 0 | 43 (1.14) | 28 (0.25) | 107 (0.57) |
| Autoimmune disorder | 1 (0.09) | 1 (0.07) | 11 (0.89) | 0 | 3 (0.08) | 42 (0.38) | 58 (0.31) |
| Back pain | 19 (1.64) | 38 (2.52) | 46 (3.73) | 0 | 91 (2.42) | 134 (1.20) | 331 (1.75) |
| Balance disorder | 1 (0.09) | 11 (0.73) | 32 (2.59) | 0 | 41 (1.09) | 48 (0.43) | 133 (0.70) |
| Bell's palsy | 0 | 6 (0.40) | 15 (1.22) | 0 | 27 (0.72) | 40 (0.36) | 88 (0.47) |
| Blood glucose increased | 7 (0.61) | 12 (0.80) | 5 (0.41) | 0 | 20 (0.53) | 15 (0.13) | 60 (0.32) |
| Blood pressure decreased | 8 (0.69) | 10 (0.66) | 3 (0.24) | 0 | 9 (0.24) | 22 (0.20) | 53 (0.28) |
| Blood pressure increased | 5 (0.43) | 21 (1.39) | 5 (0.41) | 0 | 41 (1.09) | 354 (3.16) | 427 (2.26) |
| Blood test | 3 (0.26) | 102 (6.76) | 36 (2.92) | 0 | 66 (1.75) | 96 (0.86) | 303 (1.61) |
| Blood test abnormal | 1 (0.09) | 16 (1.06) | 11 (0.89) | 0 | 12 (0.32) | 18 (0.16) | 58 (0.31) |
| Burning sensation | 1 (0.09) | 15 (0.99) | 18 (1.46) | 0 | 15 (0.40) | 62 (0.55) | 111 (0.59) |
| COVID-19 | 119 (10.29) | 36 (2.39) | 3 (0.24) | 0 | 228 (6.05) | 4730 (42.25) | 5116 (27.11) |
| COVID-19 pneumonia | 50 (4.32) | 32 (2.12) | 3 (0.24) | 0 | 88 (2.34) | 10 (0.09) | 184 (0.98) |
| Cardiac arrest | 57 (4.93) | 24 (1.59) | 0 | 0 | 7 (0.19) | 2 (0.02) | 90 (0.48) |
| Cellulitis | 1 (0.09) | 2 (0.13) | 0 | 0 | 8 (0.21) | 103 (0.92) | 114 (0.60) |
| Cerebral haemorrhage | 37 (3.20) | 24 (1.59) | 4 (0.32) | 0 | 27 (0.72) | 3 (0.03) | 96 (0.51) |
| Cerebral infarction | 9 (0.78) | 16 (1.06) | 12 (0.97) | 0 | 35 (0.93) | 7 (0.06) | 79 (0.42) |
| Cerebral thrombosis | 5 (0.43) | 22 (1.46) | 4 (0.32) | 0 | 25 (0.66) | 13 (0.12) | 70 (0.37) |
| Cerebral venous sinus thrombosis | 22 (1.90) | 30 (1.99) | 2 (0.16) | 0 | 47 (1.25) | 7 (0.06) | 110 (0.58) |
| Cerebrovascular accident | 56 (4.84) | 137 (9.08) | 58 (4.70) | 1 (12.50) | 191 (5.07) | 95 (0.85) | 538 (2.85) |
| Chest X-ray | 3 (0.26) | 28 (1.86) | 7 (0.57) | 0 | 22 (0.58) | 30 (0.27) | 90 (0.48) |
| Chest X-ray abnormal | 9 (0.78) | 20 (1.33) | 2 (0.16) | 0 | 34 (0.90) | 6 (0.05) | 71 (0.38) |
| Chest discomfort | 5 (0.43) | 27 (1.79) | 20 (1.62) | 1 (12.50) | 65 (1.73) | 96 (0.86) | 215 (1.14) |
| Chest pain | 30 (2.59) | 133 (8.82) | 38 (3.08) | 0 | 229 (6.08) | 228 (2.04) | 663 (3.51) |
| Chills | 30 (2.59) | 74 (4.91) | 333 (26.99) | 0 | 201 (5.33) | 350 (3.13) | 990 (5.25) |
| Circulatory collapse | 3 (0.26) | 3 (0.20) | 0 | 0 | 9 (0.24) | 38 (0.34) | 53 (0.28) |
| Computerised tomogram | 8 (0.69) | 89 (5.90) | 25 (2.03) | 0 | 75 (1.99) | 70 (0.63) | 267 (1.41) |
| Computerised tomogram abnormal | 5 (0.43) | 26 (1.72) | 2 (0.16) | 0 | 20 (0.53) | 22 (0.20) | 75 (0.40) |
| Computerised tomogram head | 1 (0.09) | 26 (1.72) | 8 (0.65) | 0 | 26 (0.69) | 20 (0.18) | 81 (0.43) |
| Computerised tomogram head abnormal | 21 (1.82) | 46 (3.05) | 12 (0.97) | 0 | 54 (1.43) | 3 (0.03) | 136 (0.72) |
| Computerised tomogram head normal | 3 (0.26) | 12 (0.80) | 13 (1.05) | 0 | 26 (0.69) | 4 (0.04) | 58 (0.31) |
| Computerised tomogram thorax | 2 (0.17) | 25 (1.66) | 1 (0.08) | 0 | 23 (0.61) | 25 (0.22) | 76 (0.40) |
| Computerised tomogram thorax abnormal | 9 (0.78) | 101 (6.70) | 5 (0.41) | 0 | 52 (1.38) | 6 (0.05) | 173 (0.92) |
| Condition aggravated | 27 (2.33) | 30 (1.99) | 29 (2.35) | 1 (12.50) | 66 (1.75) | 95 (0.85) | 251 (1.33) |
| Confusional state | 7 (0.61) | 18 (1.19) | 8 (0.65) | 1 (12.50) | 45 (1.19) | 43 (0.38) | 125 (0.66) |
| Contusion | 1 (0.09) | 29 (1.92) | 8 (0.65) | 0 | 41 (1.09) | 77 (0.69) | 156 (0.83) |
| Cough | 104 (8.99) | 28 (1.86) | 16 (1.30) | 0 | 158 (4.19) | 115 (1.03) | 423 (2.24) |
| Death | 411 (35.52) | 1 (0.07) | 0 | 0 | 0 | 0 | 412 (2.18) |
| Decreased appetite | 39 (3.37) | 11 (0.73) | 24 (1.94) | 0 | 61 (1.62) | 79 (0.71) | 215 (1.14) |
| Deep vein thrombosis | 23 (1.99) | 168 (11.14) | 12 (0.97) | 0 | 189 (5.02) | 294 (2.63) | 688 (3.65) |
| Dehydration | 3 (0.26) | 2 (0.13) | 4 (0.32) | 0 | 23 (0.61) | 24 (0.21) | 56 (0.30) |
| Diarrhoea | 23 (1.99) | 24 (1.59) | 26 (2.11) | 0 | 96 (2.55) | 136 (1.21) | 305 (1.62) |
| Discomfort | 3 (0.26) | 6 (0.40) | 8 (0.65) | 0 | 15 (0.40) | 52 (0.46) | 85 (0.45) |
| Disturbance in attention | 0 | 3 (0.20) | 6 (0.49) | 0 | 23 (0.61) | 42 (0.38) | 75 (0.40) |
| Dizziness | 33 (2.85) | 108 (7.16) | 92 (7.46) | 0 | 314 (8.33) | 460 (4.11) | 1013 (5.37) |
| Drug ineffective | 4 (0.35) | 6 (0.40) | 0 | 0 | 8 (0.21) | 70 (0.63) | 88 (0.47) |
| Dysarthria | 9 (0.78) | 22 (1.46) | 10 (0.81) | 0 | 52 (1.38) | 17 (0.15) | 110 (0.58) |
| Dysphagia | 7 (0.61) | 8 (0.53) | 11 (0.89) | 0 | 26 (0.69) | 20 (0.18) | 74 (0.39) |
| Dyspnoea | 157 (13.57) | 202 (13.40) | 47 (3.81) | 1 (12.50) | 389 (10.32) | 312 (2.79) | 1127 (5.97) |
| Dyspnoea exertional | 1 (0.09) | 19 (1.26) | 6 (0.49) | 0 | 16 (0.42) | 20 (0.18) | 63 (0.33) |
| Dysstasia | 3 (0.26) | 11 (0.73) | 11 (0.89) | 0 | 24 (0.64) | 21 (0.19) | 70 (0.37) |
| Echocardiogram | 5 (0.43) | 68 (4.51) | 4 (0.32) | 0 | 56 (1.49) | 15 (0.13) | 148 (0.78) |
| Electrocardiogram | 3 (0.26) | 64 (4.24) | 9 (0.73) | 0 | 37 (0.98) | 60 (0.54) | 173 (0.92) |
| Electrocardiogram abnormal | 3 (0.26) | 23 (1.53) | 5 (0.41) | 0 | 31 (0.82) | 15 (0.13) | 77 (0.41) |
| Electrocardiogram normal | 1 (0.09) | 16 (1.06) | 1 (0.08) | 0 | 20 (0.53) | 15 (0.13) | 53 (0.28) |
| Endotracheal intubation | 34 (2.94) | 20 (1.33) | 0 | 0 | 17 (0.45) | 0 | 71 (0.38) |
| Epistaxis | 2 (0.17) | 7 (0.46) | 1 (0.08) | 1 (12.50) | 19 (0.50) | 50 (0.45) | 82 (0.43) |
| Erythema | 4 (0.35) | 15 (0.99) | 4 (0.32) | 0 | 29 (0.77) | 68 (0.61) | 121 (0.64) |
| Eye pain | 0 | 10 (0.66) | 11 (0.89) | 0 | 17 (0.45) | 36 (0.32) | 75 (0.40) |
| Facial paralysis | 3 (0.26) | 23 (1.53) | 19 (1.54) | 0 | 99 (2.63) | 66 (0.59) | 210 (1.11) |
| Facial paresis | 0 | 4 (0.27) | 9 (0.73) | 0 | 29 (0.77) | 9 (0.08) | 51 (0.27) |
| Fall | 14 (1.21) | 23 (1.53) | 9 (0.73) | 0 | 79 (2.10) | 61 (0.54) | 186 (0.99) |
| Fatigue | 51 (4.41) | 105 (6.96) | 419 (33.95) | 0 | 263 (6.98) | 558 (4.98) | 1405 (7.45) |
| Feeling abnormal | 11 (0.95) | 27 (1.79) | 27 (2.19) | 0 | 86 (2.28) | 219 (1.96) | 370 (1.96) |
| Feeling cold | 2 (0.17) | 4 (0.27) | 11 (0.89) | 1 (12.50) | 9 (0.24) | 44 (0.39) | 71 (0.38) |
| Feeling hot | 1 (0.09) | 3 (0.20) | 10 (0.81) | 0 | 33 (0.88) | 72 (0.64) | 119 (0.63) |
| Fibrin D dimer | 1 (0.09) | 21 (1.39) | 3 (0.24) | 0 | 24 (0.64) | 28 (0.25) | 77 (0.41) |
| Fibrin D dimer increased | 6 (0.52) | 42 (2.79) | 3 (0.24) | 0 | 51 (1.35) | 37 (0.33) | 140 (0.74) |
| Full blood count | 2 (0.17) | 45 (2.98) | 9 (0.73) | 0 | 32 (0.85) | 47 (0.42) | 135 (0.72) |
| Gait disturbance | 5 (0.43) | 29 (1.92) | 43 (3.48) | 0 | 87 (2.31) | 84 (0.75) | 250 (1.32) |
| Gait inability | 8 (0.69) | 15 (0.99) | 15 (1.22) | 0 | 45 (1.19) | 30 (0.27) | 113 (0.60) |
| Guillain-Barre syndrome | 6 (0.52) | 64 (4.24) | 55 (4.46) | 0 | 217 (5.76) | 92 (0.82) | 434 (2.30) |
| Haemoglobin decreased | 7 (0.61) | 11 (0.73) | 1 (0.08) | 1 (12.50) | 33 (0.88) | 10 (0.09) | 63 (0.33) |
| Haemorrhage | 7 (0.61) | 8 (0.53) | 0 | 0 | 11 (0.29) | 27 (0.24) | 53 (0.28) |
| Hallucination | 0 | 2 (0.13) | 1 (0.08) | 0 | 15 (0.40) | 46 (0.41) | 65 (0.34) |
| Head discomfort | 0 | 3 (0.20) | 7 (0.57) | 0 | 14 (0.37) | 40 (0.36) | 64 (0.34) |
| Headache | 69 (5.96) | 176 (11.67) | 501 (40.60) | 0 | 541 (14.36) | 836 (7.47) | 2131 (11.29) |
| Heart rate increased | 4 (0.35) | 23 (1.53) | 18 (1.46) | 0 | 48 (1.27) | 85 (0.76) | 183 (0.97) |
| Heavy menstrual bleeding | 0 | 7 (0.46) | 12 (0.97) | 0 | 8 (0.21) | 78 (0.70) | 105 (0.56) |
| Hemiparesis | 9 (0.78) | 27 (1.79) | 15 (1.22) | 0 | 58 (1.54) | 38 (0.34) | 149 (0.79) |
| Hemiplegia | 7 (0.61) | 10 (0.66) | 12 (0.97) | 0 | 13 (0.35) | 19 (0.17) | 61 (0.32) |
| Herpes zoster | 0 | 2 (0.13) | 7 (0.57) | 0 | 19 (0.50) | 57 (0.51) | 85 (0.45) |
| Hyperhidrosis | 8 (0.69) | 24 (1.59) | 40 (3.24) | 0 | 62 (1.65) | 179 (1.60) | 314 (1.66) |
| Hypersensitivity | 0 | 12 (0.80) | 9 (0.73) | 0 | 28 (0.74) | 64 (0.57) | 113 (0.60) |
| Hypersomnia | 1 (0.09) | 3 (0.20) | 6 (0.49) | 0 | 9 (0.24) | 33 (0.29) | 52 (0.28) |
| Hypertension | 15 (1.30) | 33 (2.19) | 15 (1.22) | 1 (12.50) | 100 (2.65) | 139 (1.24) | 303 (1.61) |
| Hypoaesthesia | 5 (0.43) | 66 (4.38) | 88 (7.13) | 0 | 191 (5.07) | 249 (2.22) | 603 (3.20) |
| Hypotension | 16 (1.38) | 17 (1.13) | 4 (0.32) | 0 | 53 (1.41) | 69 (0.62) | 163 (0.86) |
| Hypoxia | 19 (1.64) | 16 (1.06) | 1 (0.08) | 0 | 26 (0.69) | 5 (0.04) | 67 (0.36) |
| Illness | 5 (0.43) | 6 (0.40) | 7 (0.57) | 0 | 26 (0.69) | 53 (0.47) | 98 (0.52) |
| Immune thrombocytopenia | 6 (0.52) | 23 (1.53) | 0 | 0 | 43 (1.14) | 14 (0.13) | 86 (0.46) |
| Immunoglobulin therapy | 2 (0.17) | 27 (1.79) | 17 (1.38) | 0 | 47 (1.25) | 1 (0.01) | 94 (0.50) |
| Impaired work ability | 1 (0.09) | 16 (1.06) | 26 (2.11) | 0 | 32 (0.85) | 48 (0.43) | 125 (0.66) |
| Incorrect route of product administration | 0 | 2 (0.13) | 1 (0.08) | 0 | 23 (0.61) | 26 (0.23) | 52 (0.28) |
| Inflammation | 0 | 7 (0.46) | 13 (1.05) | 0 | 17 (0.45) | 32 (0.29) | 70 (0.37) |
| Influenza like illness | 8 (0.69) | 8 (0.53) | 39 (3.16) | 0 | 51 (1.35) | 94 (0.84) | 202 (1.07) |
| Injection site erythema | 0 | 3 (0.20) | 4 (0.32) | 0 | 13 (0.35) | 41 (0.37) | 61 (0.32) |
| Injection site pain | 2 (0.17) | 11 (0.73) | 26 (2.11) | 0 | 64 (1.70) | 176 (1.57) | 279 (1.48) |
| Injection site reaction | 0 | 3 (0.20) | 131 (10.62) | 0 | 3 (0.08) | 13 (0.12) | 150 (0.79) |
| Injection site swelling | 0 | 1 (0.07) | 5 (0.41) | 0 | 16 (0.42) | 45 (0.40) | 67 (0.36) |
| Insomnia | 3 (0.26) | 10 (0.66) | 25 (2.03) | 0 | 45 (1.19) | 114 (1.02) | 197 (1.04) |
| Intensive care | 26 (2.25) | 57 (3.78) | 6 (0.49) | 0 | 36 (0.96) | 0 | 125 (0.66) |
| Ischaemic stroke | 4 (0.35) | 33 (2.19) | 11 (0.89) | 0 | 34 (0.90) | 10 (0.09) | 92 (0.49) |
| Joint swelling | 0 | 10 (0.66) | 4 (0.32) | 0 | 15 (0.40) | 46 (0.41) | 75 (0.40) |
| Laboratory test | 7 (0.61) | 60 (3.98) | 19 (1.54) | 0 | 34 (0.90) | 46 (0.41) | 166 (0.88) |
| Lethargy | 4 (0.35) | 6 (0.40) | 4 (0.32) | 0 | 11 (0.29) | 32 (0.29) | 57 (0.30) |
| Limb discomfort | 4 (0.35) | 11 (0.73) | 20 (1.62) | 0 | 42 (1.11) | 53 (0.47) | 130 (0.69) |
| Loss of consciousness | 29 (2.51) | 30 (1.99) | 10 (0.81) | 0 | 69 (1.83) | 217 (1.94) | 359 (1.90) |
| Loss of personal independence in daily activities | 1 (0.09) | 8 (0.53) | 24 (1.94) | 1 (12.50) | 21 (0.56) | 47 (0.42) | 106 (0.56) |
| Lumbar puncture | 0 | 13 (0.86) | 23 (1.86) | 0 | 29 (0.77) | 5 (0.04) | 70 (0.37) |
| Lymphadenopathy | 0 | 7 (0.46) | 17 (1.38) | 0 | 32 (0.85) | 47 (0.42) | 103 (0.55) |
| Magnetic resonance imaging | 2 (0.17) | 46 (3.05) | 28 (2.27) | 0 | 47 (1.25) | 39 (0.35) | 162 (0.86) |
| Magnetic resonance imaging abnormal | 0 | 22 (1.46) | 8 (0.65) | 0 | 16 (0.42) | 10 (0.09) | 56 (0.30) |
| Magnetic resonance imaging head | 0 | 16 (1.06) | 16 (1.30) | 0 | 23 (0.61) | 16 (0.14) | 71 (0.38) |
| Magnetic resonance imaging head abnormal | 4 (0.35) | 47 (3.12) | 36 (2.92) | 0 | 77 (2.04) | 6 (0.05) | 170 (0.90) |
| Malaise | 68 (5.88) | 63 (4.18) | 245 (19.85) | 0 | 186 (4.94) | 243 (2.17) | 808 (4.28) |
| Memory impairment | 1 (0.09) | 7 (0.46) | 6 (0.49) | 0 | 16 (0.42) | 21 (0.19) | 51 (0.27) |
| Metabolic function test | 3 (0.26) | 24 (1.59) | 5 (0.41) | 0 | 18 (0.48) | 30 (0.27) | 80 (0.42) |
| Migraine | 2 (0.17) | 17 (1.13) | 27 (2.19) | 0 | 35 (0.93) | 84 (0.75) | 167 (0.89) |
| Mobility decreased | 5 (0.43) | 17 (1.13) | 24 (1.94) | 0 | 28 (0.74) | 53 (0.47) | 127 (0.67) |
| Monoplegia | 0 | 3 (0.20) | 8 (0.65) | 0 | 6 (0.16) | 34 (0.30) | 51 (0.27) |
| Movement disorder | 1 (0.09) | 3 (0.20) | 12 (0.97) | 0 | 15 (0.40) | 25 (0.22) | 56 (0.30) |
| Muscle spasms | 5 (0.43) | 16 (1.06) | 21 (1.70) | 0 | 51 (1.35) | 133 (1.19) | 228 (1.21) |
| Muscular weakness | 8 (0.69) | 33 (2.19) | 58 (4.70) | 0 | 98 (2.60) | 91 (0.81) | 292 (1.55) |
| Musculoskeletal stiffness | 1 (0.09) | 4 (0.27) | 18 (1.46) | 0 | 17 (0.45) | 49 (0.44) | 89 (0.47) |
| Myalgia | 14 (1.21) | 37 (2.45) | 366 (29.66) | 0 | 199 (5.28) | 293 (2.62) | 909 (4.82) |
| Myocardial infarction | 72 (6.22) | 56 (3.71) | 4 (0.32) | 0 | 70 (1.86) | 40 (0.36) | 242 (1.28) |
| Myocarditis | 12 (1.04) | 31 (2.06) | 3 (0.24) | 0 | 79 (2.10) | 49 (0.44) | 176 (0.93) |
| Nasopharyngitis | 10 (0.86) | 5 (0.33) | 5 (0.41) | 0 | 27 (0.72) | 54 (0.48) | 101 (0.54) |
| Nausea | 29 (2.51) | 75 (4.97) | 234 (18.96) | 0 | 204 (5.41) | 384 (3.43) | 932 (4.94) |
| Neck pain | 1 (0.09) | 17 (1.13) | 28 (2.27) | 0 | 42 (1.11) | 71 (0.63) | 159 (0.84) |
| Neuralgia | 0 | 9 (0.60) | 18 (1.46) | 0 | 21 (0.56) | 53 (0.47) | 101 (0.54) |
| Neurological symptom | 2 (0.17) | 9 (0.60) | 7 (0.57) | 0 | 20 (0.53) | 15 (0.13) | 54 (0.29) |
| Neuropathy peripheral | 0 | 2 (0.13) | 20 (1.62) | 0 | 16 (0.42) | 109 (0.97) | 147 (0.78) |
| Oedema peripheral | 1 (0.09) | 8 (0.53) | 6 (0.49) | 0 | 30 (0.80) | 40 (0.36) | 86 (0.46) |
| Off label use | 5 (0.43) | 1 (0.07) | 1 (0.08) | 0 | 20 (0.53) | 52 (0.46) | 79 (0.42) |
| Oropharyngeal pain | 5 (0.43) | 9 (0.60) | 8 (0.65) | 0 | 37 (0.98) | 40 (0.36) | 99 (0.52) |
| Oxygen saturation decreased | 16 (1.38) | 10 (0.66) | 0 | 0 | 28 (0.74) | 23 (0.21) | 77 (0.41) |
| Pain | 25 (2.16) | 58 (3.85) | 105 (8.51) | 2 (25.00) | 184 (4.88) | 463 (4.14) | 841 (4.46) |
| Pain in extremity | 13 (1.12) | 112 (7.43) | 107 (8.67) | 1 (12.50) | 231 (6.13) | 585 (5.23) | 1054 (5.59) |
| Pallor | 2 (0.17) | 9 (0.60) | 5 (0.41) | 0 | 17 (0.45) | 43 (0.38) | 77 (0.41) |
| Palpitations | 3 (0.26) | 19 (1.26) | 24 (1.94) | 0 | 54 (1.43) | 81 (0.72) | 184 (0.98) |
| Paraesthesia | 5 (0.43) | 36 (2.39) | 74 (6.00) | 0 | 195 (5.18) | 284 (2.54) | 596 (3.16) |
| Paralysis | 2 (0.17) | 13 (0.86) | 10 (0.81) | 1 (12.50) | 34 (0.90) | 70 (0.63) | 131 (0.69) |
| Pericarditis | 2 (0.17) | 16 (1.06) | 3 (0.24) | 0 | 52 (1.38) | 65 (0.58) | 138 (0.73) |
| Peripheral swelling | 5 (0.43) | 60 (3.98) | 19 (1.54) | 0 | 91 (2.42) | 191 (1.71) | 367 (1.94) |
| Petechiae | 1 (0.09) | 17 (1.13) | 1 (0.08) | 0 | 37 (0.98) | 27 (0.24) | 83 (0.44) |
| Platelet count decreased | 18 (1.56) | 73 (4.84) | 3 (0.24) | 1 (12.50) | 96 (2.55) | 54 (0.48) | 245 (1.30) |
| Platelet count normal | 3 (0.26) | 19 (1.26) | 5 (0.41) | 0 | 31 (0.82) | 23 (0.21) | 81 (0.43) |
| Pneumonia | 22 (1.90) | 32 (2.12) | 4 (0.32) | 0 | 68 (1.80) | 27 (0.24) | 154 (0.82) |
| Presyncope | 0 | 6 (0.40) | 7 (0.57) | 0 | 22 (0.58) | 56 (0.50) | 91 (0.48) |
| Pruritus | 0 | 8 (0.53) | 8 (0.65) | 0 | 21 (0.56) | 56 (0.50) | 93 (0.49) |
| Pulmonary embolism | 72 (6.22) | 312 (20.69) | 8 (0.65) | 0 | 349 (9.26) | 93 (0.83) | 834 (4.42) |
| Pulmonary thrombosis | 8 (0.69) | 66 (4.38) | 2 (0.16) | 0 | 63 (1.67) | 22 (0.20) | 161 (0.85) |
| Pyrexia | 135 (11.67) | 122 (8.09) | 469 (38.01) | 1 (12.50) | 398 (10.56) | 683 (6.10) | 1819 (9.64) |
| Rash | 1 (0.09) | 14 (0.93) | 16 (1.30) | 0 | 65 (1.73) | 125 (1.12) | 222 (1.18) |
| Rheumatoid arthritis | 0 | 2 (0.13) | 7 (0.57) | 0 | 1 (0.03) | 47 (0.42) | 57 (0.30) |
| SARS-CoV-2 test negative | 7 (0.61) | 14 (0.93) | 10 (0.81) | 0 | 27 (0.72) | 13 (0.12) | 71 (0.38) |
| SARS-CoV-2 test positive | 34 (2.94) | 20 (1.33) | 1 (0.08) | 0 | 85 (2.26) | 38 (0.34) | 179 (0.95) |
| Seizure | 16 (1.38) | 26 (1.72) | 4 (0.32) | 0 | 68 (1.80) | 132 (1.18) | 247 (1.31) |
| Sensory disturbance | 0 | 4 (0.27) | 11 (0.89) | 0 | 27 (0.72) | 46 (0.41) | 89 (0.47) |
| Skin discolouration | 1 (0.09) | 8 (0.53) | 3 (0.24) | 0 | 13 (0.35) | 38 (0.34) | 63 (0.33) |
| Skin disorder | 0 | 3 (0.20) | 34 (2.76) | 0 | 7 (0.19) | 13 (0.12) | 57 (0.30) |
| Sleep disorder | 1 (0.09) | 5 (0.33) | 13 (1.05) | 0 | 19 (0.50) | 37 (0.33) | 75 (0.40) |
| Somnolence | 4 (0.35) | 10 (0.66) | 7 (0.57) | 0 | 23 (0.61) | 48 (0.43) | 93 (0.49) |
| Speech disorder | 2 (0.17) | 16 (1.06) | 14 (1.13) | 1 (12.50) | 38 (1.01) | 34 (0.30) | 106 (0.56) |
| Suspected COVID-19 | 48 (4.15) | 9 (0.60) | 0 | 0 | 50 (1.33) | 423 (3.78) | 530 (2.81) |
| Swelling | 3 (0.26) | 5 (0.33) | 7 (0.57) | 0 | 28 (0.74) | 55 (0.49) | 98 (0.52) |
| Swelling face | 0 | 5 (0.33) | 4 (0.32) | 0 | 16 (0.42) | 27 (0.24) | 54 (0.29) |
| Syncope | 14 (1.21) | 45 (2.98) | 22 (1.78) | 0 | 103 (2.73) | 437 (3.90) | 623 (3.30) |
| Tachycardia | 4 (0.35) | 28 (1.86) | 10 (0.81) | 0 | 73 (1.94) | 51 (0.46) | 167 (0.89) |
| Therapy non-responder | 1 (0.09) | 0 | 2 (0.16) | 0 | 8 (0.21) | 416 (3.72) | 427 (2.26) |
| Thrombocytopenia | 42 (3.63) | 74 (4.91) | 3 (0.24) | 0 | 115 (3.05) | 47 (0.42) | 282 (1.49) |
| Thrombosis | 98 (8.47) | 182 (12.07) | 31 (2.51) | 1 (12.50) | 234 (6.21) | 582 (5.20) | 1129 (5.98) |
| Tinnitus | 2 (0.17) | 5 (0.33) | 34 (2.76) | 0 | 29 (0.77) | 100 (0.89) | 171 (0.91) |
| Transient ischaemic attack | 3 (0.26) | 16 (1.06) | 6 (0.49) | 0 | 47 (1.25) | 40 (0.36) | 112 (0.59) |
| Tremor | 4 (0.35) | 13 (0.86) | 23 (1.86) | 0 | 56 (1.49) | 107 (0.96) | 205 (1.09) |
| Troponin increased | 8 (0.69) | 20 (1.33) | 1 (0.08) | 0 | 38 (1.01) | 3 (0.03) | 70 (0.37) |
| Ultrasound Doppler | 1 (0.09) | 26 (1.72) | 9 (0.73) | 0 | 33 (0.88) | 65 (0.58) | 134 (0.71) |
| Ultrasound Doppler abnormal | 5 (0.43) | 95 (6.30) | 10 (0.81) | 0 | 53 (1.41) | 61 (0.54) | 224 (1.19) |
| Ultrasound scan | 0 | 32 (2.12) | 5 (0.41) | 0 | 26 (0.69) | 95 (0.85) | 158 (0.84) |
| Ultrasound scan abnormal | 2 (0.17) | 17 (1.13) | 4 (0.32) | 0 | 12 (0.32) | 83 (0.74) | 118 (0.63) |
| Unresponsive to stimuli | 22 (1.90) | 13 (0.86) | 0 | 0 | 9 (0.24) | 10 (0.09) | 56 (0.30) |
| Urticaria | 0 | 3 (0.20) | 10 (0.81) | 0 | 14 (0.37) | 53 (0.47) | 81 (0.43) |
| Vaccination failure | 152 (13.14) | 45 (2.98) | 2 (0.16) | 0 | 252 (6.69) | 5169 (46.17) | 5623 (29.80) |
| Vaccination site pain | 8 (0.69) | 4 (0.27) | 25 (2.03) | 0 | 7 (0.19) | 44 (0.39) | 88 (0.47) |
| Vertigo | 4 (0.35) | 15 (0.99) | 17 (1.38) | 0 | 36 (0.96) | 67 (0.60) | 140 (0.74) |
| Vision blurred | 1 (0.09) | 18 (1.19) | 29 (2.35) | 0 | 53 (1.41) | 110 (0.98) | 212 (1.12) |
| Visual impairment | 3 (0.26) | 12 (0.80) | 27 (2.19) | 0 | 46 (1.22) | 69 (0.62) | 158 (0.84) |
| Vomiting | 34 (2.94) | 55 (3.65) | 59 (4.78) | 0 | 138 (3.66) | 187 (1.67) | 479 (2.54) |
| Weight decreased | 4 (0.35) | 6 (0.40) | 6 (0.49) | 0 | 34 (0.90) | 46 (0.41) | 98 (0.52) |
| X-ray | 2 (0.17) | 27 (1.79) | 8 (0.65) | 0 | 15 (0.40) | 16 (0.14) | 68 (0.36) |