Eudravigilance C-19 - Moderna

Liste des effets indésirables (uniquement ceux qui apparaissent dans plus de 50 cas graves)

PT

Décès

4605 (%)

Mise en jeu du pronostic vital

5112 (%)

Invalidité ou incapacité

5983 (%)

Anomalies congénitales

112 (%)

Hospitalisation

18686 (%)

Médicalement significatif

36001 (%)

Cas Graves

70499 (%)

Abdominal discomfort 12 (0.26) 16 (0.31) 21 (0.35) 1 (0.89) 67 (0.36) 59 (0.16) 183 (0.26)
Abdominal distension 7 (0.15) 13 (0.25) 7 (0.12) 0 50 (0.27) 29 (0.08) 108 (0.15)
Abdominal pain 28 (0.61) 77 (1.51) 77 (1.29) 5 (4.46) 371 (1.99) 212 (0.59) 794 (1.13)
Abdominal pain lower 2 (0.04) 17 (0.33) 10 (0.17) 0 54 (0.29) 18 (0.05) 103 (0.15)
Abdominal pain upper 27 (0.59) 48 (0.94) 59 (0.99) 0 199 (1.06) 269 (0.75) 608 (0.86)
Abnormal behaviour 4 (0.09) 6 (0.12) 4 (0.07) 0 31 (0.17) 5 (0.01) 54 (0.08)
Abortion spontaneous 0 8 (0.16) 14 (0.23) 34 (30.36) 29 (0.16) 310 (0.86) 399 (0.57)
Acute kidney injury 75 (1.63) 60 (1.17) 8 (0.13) 0 234 (1.25) 27 (0.07) 442 (0.63)
Acute myocardial infarction 51 (1.11) 113 (2.21) 6 (0.10) 0 197 (1.05) 9 (0.02) 389 (0.55)
Acute respiratory distress syndrome 27 (0.59) 13 (0.25) 1 (0.02) 0 18 (0.10) 4 (0.01) 70 (0.10)
Acute respiratory failure 107 (2.32) 43 (0.84) 3 (0.05) 0 211 (1.13) 3 (0.01) 378 (0.54)
Ageusia 6 (0.13) 11 (0.22) 39 (0.65) 1 (0.89) 68 (0.36) 45 (0.12) 174 (0.25)
Agitation 7 (0.15) 7 (0.14) 4 (0.07) 0 23 (0.12) 13 (0.04) 59 (0.08)
Alopecia 0 4 (0.08) 24 (0.40) 1 (0.89) 13 (0.07) 36 (0.10) 79 (0.11)
Altered state of consciousness 19 (0.41) 11 (0.22) 6 (0.10) 0 61 (0.33) 73 (0.20) 183 (0.26)
Amenorrhoea 0 1 (0.02) 39 (0.65) 0 4 (0.02) 58 (0.16) 102 (0.14)
Amnesia 6 (0.13) 27 (0.53) 45 (0.75) 0 67 (0.36) 32 (0.09) 183 (0.26)
Anaemia 15 (0.33) 29 (0.57) 11 (0.18) 0 96 (0.51) 12 (0.03) 177 (0.25)
Anaphylactic reaction 2 (0.04) 209 (4.09) 9 (0.15) 0 289 (1.55) 811 (2.25) 1338 (1.90)
Anaphylactic shock 3 (0.07) 47 (0.92) 1 (0.02) 0 46 (0.25) 54 (0.15) 155 (0.22)
Anaphylactoid reaction 0 1 (0.02) 0 0 16 (0.09) 35 (0.10) 54 (0.08)
Angina pectoris 4 (0.09) 13 (0.25) 17 (0.28) 0 72 (0.39) 182 (0.51) 294 (0.42)
Angioedema 0 34 (0.67) 5 (0.08) 0 52 (0.28) 403 (1.12) 503 (0.71)
Anosmia 6 (0.13) 8 (0.16) 30 (0.50) 0 50 (0.27) 30 (0.08) 128 (0.18)
Anticoagulant therapy 1 (0.02) 29 (0.57) 0 0 28 (0.15) 0 59 (0.08)
Anxiety 4 (0.09) 24 (0.47) 81 (1.35) 1 (0.89) 100 (0.54) 82 (0.23) 301 (0.43)
Aphasia 15 (0.33) 75 (1.47) 62 (1.04) 0 175 (0.94) 15 (0.04) 359 (0.51)
Appendicitis 0 51 (1.00) 1 (0.02) 0 121 (0.65) 35 (0.10) 210 (0.30)
Arrhythmia 20 (0.43) 42 (0.82) 29 (0.48) 0 149 (0.80) 347 (0.96) 597 (0.85)
Arthralgia 21 (0.46) 108 (2.11) 941 (15.73) 1 (0.89) 403 (2.16) 1049 (2.91) 2546 (3.61)
Arthritis 2 (0.04) 3 (0.06) 45 (0.75) 0 24 (0.13) 33 (0.09) 107 (0.15)
Asthenia 168 (3.65) 268 (5.24) 335 (5.60) 1 (0.89) 1109 (5.93) 516 (1.43) 2511 (3.56)
Asthma 6 (0.13) 35 (0.68) 14 (0.23) 0 76 (0.41) 56 (0.16) 189 (0.27)
Asymptomatic COVID-19 4 (0.09) 0 0 0 62 (0.33) 5 (0.01) 71 (0.10)
Atelectasis 11 (0.24) 13 (0.25) 2 (0.03) 0 77 (0.41) 0 106 (0.15)
Atrial fibrillation 40 (0.87) 139 (2.72) 32 (0.53) 0 390 (2.09) 479 (1.33) 1114 (1.58)
Atrial flutter 1 (0.02) 14 (0.27) 1 (0.02) 0 33 (0.18) 12 (0.03) 66 (0.09)
Autoimmune disorder 2 (0.04) 5 (0.10) 17 (0.28) 0 20 (0.11) 72 (0.20) 125 (0.18)
Axillary pain 1 (0.02) 9 (0.18) 59 (0.99) 0 22 (0.12) 224 (0.62) 317 (0.45)
Back pain 29 (0.63) 75 (1.47) 167 (2.79) 4 (3.57) 234 (1.25) 324 (0.90) 856 (1.21)
Balance disorder 9 (0.20) 30 (0.59) 95 (1.59) 0 123 (0.66) 64 (0.18) 332 (0.47)
Bedridden 5 (0.11) 8 (0.16) 7 (0.12) 0 9 (0.05) 23 (0.06) 53 (0.08)
Bell's palsy 0 6 (0.12) 107 (1.79) 1 (0.89) 93 (0.50) 1211 (3.36) 1425 (2.02)
Blindness 3 (0.07) 13 (0.25) 59 (0.99) 0 38 (0.20) 190 (0.53) 311 (0.44)
Blindness transient 0 0 3 (0.05) 0 9 (0.05) 42 (0.12) 57 (0.08)
Blindness unilateral 1 (0.02) 7 (0.14) 60 (1.00) 0 21 (0.11) 41 (0.11) 136 (0.19)
Blister 2 (0.04) 9 (0.18) 27 (0.45) 0 32 (0.17) 42 (0.12) 114 (0.16)
Blood glucose increased 5 (0.11) 3 (0.06) 4 (0.07) 0 31 (0.17) 9 (0.02) 56 (0.08)
Blood pressure decreased 4 (0.09) 14 (0.27) 11 (0.18) 0 49 (0.26) 34 (0.09) 115 (0.16)
Blood pressure increased 3 (0.07) 37 (0.72) 25 (0.42) 1 (0.89) 133 (0.71) 68 (0.19) 278 (0.39)
Body temperature increased 8 (0.17) 6 (0.12) 7 (0.12) 0 45 (0.24) 26 (0.07) 96 (0.14)
Bone pain 2 (0.04) 11 (0.22) 29 (0.48) 0 18 (0.10) 50 (0.14) 111 (0.16)
Bradycardia 16 (0.35) 33 (0.65) 3 (0.05) 1 (0.89) 63 (0.34) 206 (0.57) 332 (0.47)
Brain oedema 5 (0.11) 15 (0.29) 5 (0.08) 0 14 (0.07) 13 (0.04) 55 (0.08)
Breast pain 1 (0.02) 9 (0.18) 17 (0.28) 0 26 (0.14) 38 (0.11) 91 (0.13)
Bronchitis 3 (0.07) 5 (0.10) 2 (0.03) 0 33 (0.18) 16 (0.04) 60 (0.09)
Burning sensation 2 (0.04) 27 (0.53) 84 (1.40) 2 (1.79) 40 (0.21) 75 (0.21) 235 (0.33)
C-reactive protein increased 1 (0.02) 4 (0.08) 1 (0.02) 0 45 (0.24) 11 (0.03) 64 (0.09)
COVID-19 477 (10.36) 93 (1.82) 26 (0.43) 1 (0.89) 2119 (11.34) 842 (2.34) 3632 (5.15)
COVID-19 immunisation 0 9 (0.18) 23 (0.38) 0 38 (0.20) 23 (0.06) 93 (0.13)
COVID-19 pneumonia 141 (3.06) 18 (0.35) 3 (0.05) 0 396 (2.12) 48 (0.13) 628 (0.89)
Cardiac arrest 326 (7.08) 93 (1.82) 2 (0.03) 0 30 (0.16) 10 (0.03) 481 (0.68)
Cardiac disorder 16 (0.35) 21 (0.41) 13 (0.22) 0 45 (0.24) 10 (0.03) 114 (0.16)
Cardiac failure 63 (1.37) 41 (0.80) 10 (0.17) 0 96 (0.51) 28 (0.08) 252 (0.36)
Cardiac failure acute 17 (0.37) 6 (0.12) 0 0 29 (0.16) 0 54 (0.08)
Cardiac failure congestive 35 (0.76) 40 (0.78) 10 (0.17) 0 109 (0.58) 26 (0.07) 230 (0.33)
Cardiac flutter 1 (0.02) 11 (0.22) 7 (0.12) 0 21 (0.11) 322 (0.89) 365 (0.52)
Cardio-respiratory arrest 101 (2.19) 27 (0.53) 0 0 9 (0.05) 8 (0.02) 154 (0.22)
Cardiogenic shock 29 (0.63) 15 (0.29) 0 0 8 (0.04) 3 (0.01) 58 (0.08)
Cardiomegaly 12 (0.26) 20 (0.39) 5 (0.08) 1 (0.89) 60 (0.32) 6 (0.02) 109 (0.15)
Cardiomyopathy 6 (0.13) 21 (0.41) 4 (0.07) 0 24 (0.13) 13 (0.04) 70 (0.10)
Cardiovascular disorder 9 (0.20) 4 (0.08) 8 (0.13) 0 15 (0.08) 19 (0.05) 58 (0.08)
Cellulitis 5 (0.11) 10 (0.20) 8 (0.13) 0 100 (0.54) 883 (2.45) 1021 (1.45)
Cerebral haemorrhage 66 (1.43) 52 (1.02) 14 (0.23) 0 62 (0.33) 16 (0.04) 220 (0.31)
Cerebral infarction 8 (0.17) 41 (0.80) 27 (0.45) 0 102 (0.55) 12 (0.03) 194 (0.28)
Cerebral thrombosis 11 (0.24) 30 (0.59) 8 (0.13) 0 40 (0.21) 3 (0.01) 94 (0.13)
Cerebral venous sinus thrombosis 4 (0.09) 39 (0.76) 5 (0.08) 0 41 (0.22) 4 (0.01) 93 (0.13)
Cerebrovascular accident 116 (2.52) 332 (6.49) 167 (2.79) 0 515 (2.76) 209 (0.58) 1383 (1.96)
Chest discomfort 24 (0.52) 179 (3.50) 74 (1.24) 0 464 (2.48) 270 (0.75) 1034 (1.47)
Chest pain 75 (1.63) 414 (8.10) 172 (2.87) 1 (0.89) 1441 (7.71) 589 (1.64) 2755 (3.91)
Chills 63 (1.37) 196 (3.83) 891 (14.89) 5 (4.46) 908 (4.86) 1696 (4.71) 3814 (5.41)
Choking 4 (0.09) 5 (0.10) 1 (0.02) 0 6 (0.03) 45 (0.12) 62 (0.09)
Chromaturia 1 (0.02) 12 (0.23) 5 (0.08) 0 29 (0.16) 11 (0.03) 60 (0.09)
Chronic obstructive pulmonary disease 20 (0.43) 7 (0.14) 2 (0.03) 0 67 (0.36) 6 (0.02) 107 (0.15)
Circulatory collapse 10 (0.22) 7 (0.14) 1 (0.02) 0 18 (0.10) 55 (0.15) 99 (0.14)
Cognitive disorder 7 (0.15) 10 (0.20) 50 (0.84) 0 24 (0.13) 15 (0.04) 109 (0.15)
Cold sweat 10 (0.22) 21 (0.41) 23 (0.38) 0 65 (0.35) 101 (0.28) 229 (0.32)
Colitis 3 (0.07) 10 (0.20) 3 (0.05) 0 37 (0.20) 8 (0.02) 62 (0.09)
Colitis ulcerative 0 0 5 (0.08) 0 15 (0.08) 49 (0.14) 71 (0.10)
Coma 11 (0.24) 17 (0.33) 1 (0.02) 0 15 (0.08) 6 (0.02) 58 (0.08)
Condition aggravated 110 (2.39) 152 (2.97) 283 (4.73) 1 (0.89) 519 (2.78) 115 (0.32) 1219 (1.73)
Confusional state 50 (1.09) 80 (1.56) 96 (1.60) 0 364 (1.95) 106 (0.29) 742 (1.05)
Conjunctival haemorrhage 0 1 (0.02) 3 (0.05) 0 3 (0.02) 48 (0.13) 55 (0.08)
Constipation 2 (0.04) 7 (0.14) 17 (0.28) 0 56 (0.30) 28 (0.08) 112 (0.16)
Contusion 2 (0.04) 38 (0.74) 38 (0.64) 0 84 (0.45) 98 (0.27) 268 (0.38)
Coordination abnormal 2 (0.04) 6 (0.12) 15 (0.25) 0 21 (0.11) 8 (0.02) 53 (0.08)
Coronary artery disease 15 (0.33) 15 (0.29) 3 (0.05) 0 32 (0.17) 1 (0.00) 70 (0.10)
Coronary artery occlusion 6 (0.13) 29 (0.57) 1 (0.02) 0 24 (0.13) 3 (0.01) 66 (0.09)
Cough 122 (2.65) 131 (2.56) 85 (1.42) 1 (0.89) 783 (4.19) 267 (0.74) 1435 (2.04)
Cyanosis 27 (0.59) 12 (0.23) 11 (0.18) 0 22 (0.12) 10 (0.03) 87 (0.12)
Deafness 1 (0.02) 2 (0.04) 83 (1.39) 0 11 (0.06) 310 (0.86) 412 (0.58)
Deafness neurosensory 0 2 (0.04) 52 (0.87) 0 2 (0.01) 52 (0.14) 110 (0.16)
Deafness unilateral 0 2 (0.04) 132 (2.21) 0 12 (0.06) 201 (0.56) 353 (0.50)
Death 2282 (49.55) 1 (0.02) 0 0 0 0 2283 (3.24)
Decreased appetite 86 (1.87) 63 (1.23) 105 (1.75) 1 (0.89) 312 (1.67) 213 (0.59) 820 (1.16)
Deep vein thrombosis 18 (0.39) 288 (5.63) 15 (0.25) 1 (0.89) 309 (1.65) 488 (1.36) 1146 (1.63)
Dehydration 15 (0.33) 42 (0.82) 21 (0.35) 0 200 (1.07) 34 (0.09) 325 (0.46)
Delirium 9 (0.20) 18 (0.35) 11 (0.18) 0 33 (0.18) 131 (0.36) 213 (0.30)
Dementia 13 (0.28) 6 (0.12) 9 (0.15) 0 14 (0.07) 29 (0.08) 81 (0.11)
Depressed level of consciousness 11 (0.24) 19 (0.37) 5 (0.08) 0 48 (0.26) 162 (0.45) 261 (0.37)
Depressed mood 1 (0.02) 5 (0.10) 11 (0.18) 1 (0.89) 2 (0.01) 45 (0.12) 66 (0.09)
Depression 2 (0.04) 15 (0.29) 31 (0.52) 1 (0.89) 26 (0.14) 42 (0.12) 122 (0.17)
Diabetes mellitus 13 (0.28) 13 (0.25) 7 (0.12) 0 21 (0.11) 30 (0.08) 87 (0.12)
Diabetic ketoacidosis 3 (0.07) 21 (0.41) 3 (0.05) 0 28 (0.15) 2 (0.01) 59 (0.08)
Diarrhoea 55 (1.19) 119 (2.33) 151 (2.52) 1 (0.89) 571 (3.06) 520 (1.44) 1457 (2.07)
Diarrhoea haemorrhagic 2 (0.04) 5 (0.10) 0 0 10 (0.05) 46 (0.13) 65 (0.09)
Diplopia 0 23 (0.45) 53 (0.89) 0 76 (0.41) 26 (0.07) 182 (0.26)
Discomfort 14 (0.30) 16 (0.31) 39 (0.65) 0 63 (0.34) 64 (0.18) 203 (0.29)
Disorientation 8 (0.17) 32 (0.63) 32 (0.53) 0 81 (0.43) 34 (0.09) 193 (0.27)
Disturbance in attention 0 15 (0.29) 48 (0.80) 0 51 (0.27) 84 (0.23) 200 (0.28)
Diverticulitis 0 1 (0.02) 1 (0.02) 0 35 (0.19) 36 (0.10) 74 (0.10)
Dizziness 53 (1.15) 302 (5.91) 493 (8.24) 3 (2.68) 1114 (5.96) 1224 (3.40) 3257 (4.62)
Dizziness postural 0 2 (0.04) 13 (0.22) 0 18 (0.10) 57 (0.16) 91 (0.13)
Drug ineffective 12 (0.26) 4 (0.08) 2 (0.03) 0 49 (0.26) 25 (0.07) 94 (0.13)
Dry mouth 0 10 (0.20) 11 (0.18) 0 28 (0.15) 46 (0.13) 95 (0.13)
Dysarthria 7 (0.15) 56 (1.10) 47 (0.79) 0 153 (0.82) 32 (0.09) 306 (0.43)
Dysgeusia 1 (0.02) 10 (0.20) 13 (0.22) 0 14 (0.07) 73 (0.20) 112 (0.16)
Dyskinesia 1 (0.02) 9 (0.18) 18 (0.30) 0 40 (0.21) 14 (0.04) 84 (0.12)
Dysmenorrhoea 0 3 (0.06) 53 (0.89) 0 14 (0.07) 209 (0.58) 280 (0.40)
Dyspepsia 6 (0.13) 14 (0.27) 18 (0.30) 0 28 (0.15) 51 (0.14) 119 (0.17)
Dysphagia 19 (0.41) 68 (1.33) 47 (0.79) 0 119 (0.64) 44 (0.12) 317 (0.45)
Dysphonia 5 (0.11) 20 (0.39) 14 (0.23) 0 40 (0.21) 17 (0.05) 100 (0.14)
Dyspnoea 392 (8.51) 816 (15.96) 326 (5.45) 2 (1.79) 2319 (12.41) 804 (2.23) 4865 (6.90)
Dyspnoea exertional 12 (0.26) 52 (1.02) 19 (0.32) 0 141 (0.75) 41 (0.11) 277 (0.39)
Dysstasia 6 (0.13) 27 (0.53) 73 (1.22) 0 86 (0.46) 16 (0.04) 216 (0.31)
Dysuria 1 (0.02) 8 (0.16) 9 (0.15) 0 26 (0.14) 14 (0.04) 59 (0.08)
Ear discomfort 0 7 (0.14) 62 (1.04) 0 15 (0.08) 16 (0.04) 101 (0.14)
Ear pain 0 9 (0.18) 60 (1.00) 1 (0.89) 33 (0.18) 85 (0.24) 188 (0.27)
Encephalitis 2 (0.04) 16 (0.31) 4 (0.07) 0 34 (0.18) 8 (0.02) 68 (0.10)
Encephalopathy 13 (0.28) 19 (0.37) 7 (0.12) 0 74 (0.40) 9 (0.02) 129 (0.18)
Endotracheal intubation 17 (0.37) 20 (0.39) 1 (0.02) 0 16 (0.09) 0 58 (0.08)
Epilepsy 3 (0.07) 17 (0.33) 5 (0.08) 0 62 (0.33) 74 (0.21) 163 (0.23)
Epistaxis 12 (0.26) 33 (0.65) 11 (0.18) 1 (0.89) 54 (0.29) 67 (0.19) 184 (0.26)
Erectile dysfunction 0 0 5 (0.08) 0 1 (0.01) 49 (0.14) 55 (0.08)
Erysipelas 0 2 (0.04) 3 (0.05) 0 10 (0.05) 78 (0.22) 94 (0.13)
Erythema 9 (0.20) 65 (1.27) 80 (1.34) 2 (1.79) 217 (1.16) 340 (0.94) 724 (1.03)
Erythema multiforme 0 1 (0.02) 1 (0.02) 0 11 (0.06) 171 (0.47) 184 (0.26)
Exposure during pregnancy 0 8 (0.16) 4 (0.07) 15 (13.39) 65 (0.35) 27 (0.07) 122 (0.17)
Exposure to SARS-CoV-2 9 (0.20) 1 (0.02) 2 (0.03) 0 47 (0.25) 3 (0.01) 65 (0.09)
Extensive swelling of vaccinated limb 0 5 (0.10) 152 (2.54) 0 6 (0.03) 31 (0.09) 194 (0.28)
Extrasystoles 1 (0.02) 16 (0.31) 15 (0.25) 0 16 (0.09) 23 (0.06) 71 (0.10)
Eye haemorrhage 1 (0.02) 3 (0.06) 6 (0.10) 0 5 (0.03) 92 (0.26) 114 (0.16)
Eye pain 0 8 (0.16) 75 (1.25) 0 40 (0.21) 113 (0.31) 239 (0.34)
Eye swelling 0 15 (0.29) 18 (0.30) 0 15 (0.08) 29 (0.08) 79 (0.11)
Face oedema 0 6 (0.12) 2 (0.03) 0 17 (0.09) 32 (0.09) 57 (0.08)
Facial pain 0 3 (0.06) 23 (0.38) 0 12 (0.06) 20 (0.06) 59 (0.08)
Facial paralysis 1 (0.02) 38 (0.74) 95 (1.59) 1 (0.89) 207 (1.11) 755 (2.10) 1117 (1.58)
Facial paresis 1 (0.02) 6 (0.12) 22 (0.37) 0 57 (0.31) 36 (0.10) 123 (0.17)
Fall 77 (1.67) 84 (1.64) 87 (1.45) 0 453 (2.42) 63 (0.17) 813 (1.15)
Fatigue 144 (3.13) 353 (6.91) 1456 (24.34) 9 (8.04) 1220 (6.53) 2370 (6.58) 5656 (8.02)
Feeding disorder 8 (0.17) 15 (0.29) 17 (0.28) 0 42 (0.22) 19 (0.05) 107 (0.15)
Feeling abnormal 34 (0.74) 93 (1.82) 194 (3.24) 2 (1.79) 272 (1.46) 183 (0.51) 807 (1.14)
Feeling cold 4 (0.09) 24 (0.47) 48 (0.80) 0 47 (0.25) 108 (0.30) 234 (0.33)
Feeling hot 8 (0.17) 25 (0.49) 55 (0.92) 0 125 (0.67) 149 (0.41) 366 (0.52)
Feeling of body temperature change 2 (0.04) 3 (0.06) 16 (0.27) 0 21 (0.11) 57 (0.16) 100 (0.14)
Fibrin D dimer increased 3 (0.07) 8 (0.16) 5 (0.08) 0 46 (0.25) 20 (0.06) 86 (0.12)
Flank pain 2 (0.04) 18 (0.35) 14 (0.23) 0 34 (0.18) 8 (0.02) 76 (0.11)
Flushing 2 (0.04) 30 (0.59) 12 (0.20) 0 57 (0.31) 37 (0.10) 139 (0.20)
Foetal death 3 (0.07) 2 (0.04) 1 (0.02) 6 (5.36) 15 (0.08) 24 (0.07) 53 (0.08)
Gait disturbance 10 (0.22) 69 (1.35) 181 (3.03) 0 275 (1.47) 76 (0.21) 641 (0.91)
Gait inability 14 (0.30) 39 (0.76) 102 (1.70) 1 (0.89) 143 (0.77) 13 (0.04) 323 (0.46)
Gastrointestinal haemorrhage 17 (0.37) 20 (0.39) 1 (0.02) 0 42 (0.22) 16 (0.04) 101 (0.14)
Gastrooesophageal reflux disease 2 (0.04) 9 (0.18) 5 (0.08) 0 23 (0.12) 15 (0.04) 54 (0.08)
Gaze palsy 2 (0.04) 7 (0.14) 3 (0.05) 0 11 (0.06) 66 (0.18) 92 (0.13)
General physical health deterioration 100 (2.17) 19 (0.37) 20 (0.33) 0 60 (0.32) 15 (0.04) 240 (0.34)
Generalised tonic-clonic seizure 3 (0.07) 15 (0.29) 5 (0.08) 0 42 (0.22) 101 (0.28) 169 (0.24)
Guillain-Barre syndrome 4 (0.09) 52 (1.02) 63 (1.05) 0 149 (0.80) 66 (0.18) 339 (0.48)
Haematemesis 12 (0.26) 8 (0.16) 0 0 12 (0.06) 43 (0.12) 78 (0.11)
Haematochezia 3 (0.07) 4 (0.08) 5 (0.08) 0 30 (0.16) 138 (0.38) 187 (0.27)
Haematoma 5 (0.11) 13 (0.25) 11 (0.18) 0 28 (0.15) 25 (0.07) 84 (0.12)
Haematuria 3 (0.07) 8 (0.16) 2 (0.03) 0 29 (0.16) 22 (0.06) 71 (0.10)
Haemoptysis 9 (0.20) 23 (0.45) 3 (0.05) 0 31 (0.17) 3 (0.01) 75 (0.11)
Haemorrhage 20 (0.43) 23 (0.45) 12 (0.20) 1 (0.89) 42 (0.22) 267 (0.74) 379 (0.54)
Haemorrhagic stroke 21 (0.46) 11 (0.22) 2 (0.03) 0 11 (0.06) 6 (0.02) 54 (0.08)
Hallucination 5 (0.11) 6 (0.12) 15 (0.25) 0 48 (0.26) 318 (0.88) 403 (0.57)
Hallucination, visual 0 0 2 (0.03) 0 5 (0.03) 43 (0.12) 52 (0.07)
Head discomfort 1 (0.02) 7 (0.14) 36 (0.60) 0 29 (0.16) 37 (0.10) 113 (0.16)
Head injury 11 (0.24) 18 (0.35) 5 (0.08) 0 69 (0.37) 21 (0.06) 130 (0.18)
Headache 74 (1.61) 375 (7.34) 1413 (23.62) 9 (8.04) 1436 (7.68) 3221 (8.95) 6620 (9.39)
Heart rate increased 9 (0.20) 57 (1.12) 63 (1.05) 1 (0.89) 164 (0.88) 112 (0.31) 421 (0.60)
Heart rate irregular 4 (0.09) 8 (0.16) 16 (0.27) 0 30 (0.16) 23 (0.06) 84 (0.12)
Heavy menstrual bleeding 0 11 (0.22) 68 (1.14) 0 38 (0.20) 365 (1.01) 482 (0.68)
Hemiparesis 6 (0.13) 46 (0.90) 67 (1.12) 0 130 (0.70) 99 (0.27) 366 (0.52)
Hemiplegia 4 (0.09) 28 (0.55) 31 (0.52) 0 36 (0.19) 39 (0.11) 150 (0.21)
Herpes zoster 6 (0.13) 14 (0.27) 56 (0.94) 0 112 (0.60) 269 (0.75) 463 (0.66)
Hospitalisation 10 (0.22) 2 (0.04) 0 0 213 (1.14) 0 239 (0.34)
Hot flush 0 14 (0.27) 32 (0.53) 1 (0.89) 26 (0.14) 103 (0.29) 177 (0.25)
Hyperglycaemia 3 (0.07) 11 (0.22) 1 (0.02) 0 36 (0.19) 7 (0.02) 63 (0.09)
Hyperhidrosis 21 (0.46) 95 (1.86) 116 (1.94) 0 234 (1.25) 409 (1.14) 891 (1.26)
Hyperkalaemia 11 (0.24) 2 (0.04) 0 0 23 (0.12) 5 (0.01) 51 (0.07)
Hyperpyrexia 9 (0.20) 8 (0.16) 2 (0.03) 0 15 (0.08) 160 (0.44) 196 (0.28)
Hypersensitivity 4 (0.09) 60 (1.17) 28 (0.47) 0 154 (0.82) 254 (0.71) 506 (0.72)
Hypersomnia 3 (0.07) 17 (0.33) 18 (0.30) 1 (0.89) 25 (0.13) 21 (0.06) 90 (0.13)
Hypertension 35 (0.76) 109 (2.13) 68 (1.14) 0 361 (1.93) 194 (0.54) 792 (1.12)
Hypertensive crisis 1 (0.02) 15 (0.29) 0 0 35 (0.19) 60 (0.17) 113 (0.16)
Hyperthyroidism 0 4 (0.08) 5 (0.08) 0 5 (0.03) 43 (0.12) 57 (0.08)
Hyperventilation 4 (0.09) 7 (0.14) 1 (0.02) 0 42 (0.22) 6 (0.02) 63 (0.09)
Hypoacusis 0 3 (0.06) 65 (1.09) 0 24 (0.13) 31 (0.09) 125 (0.18)
Hypoaesthesia 4 (0.09) 125 (2.45) 371 (6.20) 0 504 (2.70) 328 (0.91) 1361 (1.93)
Hypoaesthesia oral 1 (0.02) 12 (0.23) 29 (0.48) 0 55 (0.29) 38 (0.11) 138 (0.20)
Hypokalaemia 7 (0.15) 7 (0.14) 2 (0.03) 0 42 (0.22) 23 (0.06) 88 (0.12)
Hypokinesia 3 (0.07) 3 (0.06) 7 (0.12) 0 31 (0.17) 15 (0.04) 63 (0.09)
Hyponatraemia 10 (0.22) 12 (0.23) 3 (0.05) 0 66 (0.35) 1 (0.00) 103 (0.15)
Hypophagia 14 (0.30) 9 (0.18) 3 (0.05) 0 67 (0.36) 2 (0.01) 102 (0.14)
Hypotension 73 (1.59) 78 (1.53) 28 (0.47) 0 247 (1.32) 114 (0.32) 571 (0.81)
Hypothyroidism 1 (0.02) 1 (0.02) 7 (0.12) 0 12 (0.06) 26 (0.07) 51 (0.07)
Hypoxia 98 (2.13) 63 (1.23) 3 (0.05) 0 339 (1.81) 53 (0.15) 595 (0.84)
Illness 27 (0.59) 19 (0.37) 39 (0.65) 1 (0.89) 64 (0.34) 186 (0.52) 349 (0.50)
Immediate post-injection reaction 5 (0.11) 26 (0.51) 51 (0.85) 0 39 (0.21) 3 (0.01) 124 (0.18)
Immune thrombocytopenia 4 (0.09) 63 (1.23) 3 (0.05) 0 108 (0.58) 46 (0.13) 226 (0.32)
Impaired driving ability 2 (0.04) 17 (0.33) 42 (0.70) 0 28 (0.15) 10 (0.03) 103 (0.15)
Impaired work ability 4 (0.09) 47 (0.92) 168 (2.81) 2 (1.79) 69 (0.37) 44 (0.12) 346 (0.49)
Inappropriate schedule of product administration 6 (0.13) 4 (0.08) 4 (0.07) 1 (0.89) 31 (0.17) 11 (0.03) 58 (0.08)
Infection 6 (0.13) 13 (0.25) 16 (0.27) 0 85 (0.45) 34 (0.09) 156 (0.22)
Inflammation 3 (0.07) 25 (0.49) 74 (1.24) 0 93 (0.50) 47 (0.13) 247 (0.35)
Influenza 2 (0.04) 12 (0.23) 25 (0.42) 0 73 (0.39) 193 (0.54) 307 (0.44)
Influenza like illness 12 (0.26) 31 (0.61) 158 (2.64) 0 183 (0.98) 444 (1.23) 836 (1.19)
Injected limb mobility decreased 1 (0.02) 6 (0.12) 83 (1.39) 0 5 (0.03) 26 (0.07) 122 (0.17)
Injection site erythema 3 (0.07) 11 (0.22) 61 (1.02) 0 69 (0.37) 126 (0.35) 270 (0.38)
Injection site pain 12 (0.26) 31 (0.61) 162 (2.71) 1 (0.89) 157 (0.84) 392 (1.09) 761 (1.08)
Injection site pruritus 3 (0.07) 6 (0.12) 24 (0.40) 0 18 (0.10) 42 (0.12) 93 (0.13)
Injection site rash 0 6 (0.12) 15 (0.25) 0 16 (0.09) 60 (0.17) 97 (0.14)
Injection site reaction 1 (0.02) 6 (0.12) 492 (8.22) 0 23 (0.12) 124 (0.34) 647 (0.92)
Injection site swelling 3 (0.07) 15 (0.29) 48 (0.80) 0 71 (0.38) 88 (0.24) 228 (0.32)
Injection site warmth 1 (0.02) 6 (0.12) 23 (0.38) 0 8 (0.04) 36 (0.10) 74 (0.10)
Insomnia 8 (0.17) 23 (0.45) 104 (1.74) 2 (1.79) 56 (0.30) 196 (0.54) 397 (0.56)
Intensive care 11 (0.24) 31 (0.61) 1 (0.02) 0 34 (0.18) 0 77 (0.11)
Intermenstrual bleeding 0 2 (0.04) 18 (0.30) 2 (1.79) 8 (0.04) 107 (0.30) 137 (0.19)
Interstitial lung disease 9 (0.20) 8 (0.16) 3 (0.05) 0 33 (0.18) 8 (0.02) 66 (0.09)
Ischaemic stroke 19 (0.41) 59 (1.15) 29 (0.48) 0 148 (0.79) 16 (0.04) 274 (0.39)
Joint range of motion decreased 1 (0.02) 5 (0.10) 51 (0.85) 0 12 (0.06) 2 (0.01) 71 (0.10)
Joint stiffness 1 (0.02) 3 (0.06) 34 (0.57) 0 11 (0.06) 26 (0.07) 77 (0.11)
Joint swelling 2 (0.04) 16 (0.31) 71 (1.19) 0 45 (0.24) 32 (0.09) 170 (0.24)
Lactic acidosis 12 (0.26) 8 (0.16) 1 (0.02) 0 29 (0.16) 2 (0.01) 55 (0.08)
Lethargy 37 (0.80) 42 (0.82) 36 (0.60) 1 (0.89) 133 (0.71) 154 (0.43) 417 (0.59)
Leukocytosis 8 (0.17) 9 (0.18) 1 (0.02) 0 59 (0.32) 3 (0.01) 88 (0.12)
Leukopenia 4 (0.09) 6 (0.12) 1 (0.02) 0 23 (0.12) 15 (0.04) 52 (0.07)
Limb discomfort 3 (0.07) 24 (0.47) 58 (0.97) 0 118 (0.63) 125 (0.35) 333 (0.47)
Lip swelling 1 (0.02) 34 (0.67) 14 (0.23) 1 (0.89) 73 (0.39) 59 (0.16) 187 (0.27)
Loss of consciousness 78 (1.69) 152 (2.97) 53 (0.89) 1 (0.89) 405 (2.17) 2752 (7.64) 3544 (5.03)
Loss of personal independence in daily activities 3 (0.07) 44 (0.86) 148 (2.47) 0 69 (0.37) 16 (0.04) 297 (0.42)
Lower respiratory tract infection 1 (0.02) 2 (0.04) 4 (0.07) 0 6 (0.03) 45 (0.12) 59 (0.08)
Lung disorder 12 (0.26) 6 (0.12) 4 (0.07) 0 41 (0.22) 7 (0.02) 74 (0.10)
Lung infiltration 24 (0.52) 20 (0.39) 0 0 101 (0.54) 0 158 (0.22)
Lung opacity 22 (0.48) 40 (0.78) 3 (0.05) 0 150 (0.80) 1 (0.00) 222 (0.31)
Lymph node pain 1 (0.02) 3 (0.06) 18 (0.30) 0 12 (0.06) 69 (0.19) 104 (0.15)
Lymphadenopathy 10 (0.22) 43 (0.84) 142 (2.37) 0 172 (0.92) 663 (1.84) 1040 (1.48)
Malaise 149 (3.24) 158 (3.09) 657 (10.98) 5 (4.46) 635 (3.40) 547 (1.52) 2211 (3.14)
Maternal exposure during breast feeding 0 0 5 (0.08) 0 1 (0.01) 112 (0.31) 118 (0.17)
Maternal exposure during pregnancy 1 (0.02) 12 (0.23) 7 (0.12) 16 (14.29) 61 (0.33) 122 (0.34) 222 (0.31)
Memory impairment 6 (0.13) 22 (0.43) 55 (0.92) 0 89 (0.48) 30 (0.08) 209 (0.30)
Menstrual disorder 0 2 (0.04) 42 (0.70) 0 16 (0.09) 126 (0.35) 188 (0.27)
Menstruation delayed 0 1 (0.02) 27 (0.45) 0 3 (0.02) 161 (0.45) 192 (0.27)
Menstruation irregular 0 1 (0.02) 39 (0.65) 2 (1.79) 16 (0.09) 146 (0.41) 206 (0.29)
Mental impairment 2 (0.04) 3 (0.06) 23 (0.38) 0 18 (0.10) 159 (0.44) 212 (0.30)
Mental status changes 33 (0.72) 39 (0.76) 7 (0.12) 0 164 (0.88) 2 (0.01) 258 (0.37)
Migraine 2 (0.04) 27 (0.53) 135 (2.26) 0 105 (0.56) 314 (0.87) 589 (0.84)
Mobility decreased 17 (0.37) 68 (1.33) 181 (3.03) 2 (1.79) 176 (0.94) 30 (0.08) 490 (0.70)
Monoplegia 0 4 (0.08) 17 (0.28) 0 22 (0.12) 95 (0.26) 141 (0.20)
Movement disorder 6 (0.13) 9 (0.18) 41 (0.69) 0 35 (0.19) 17 (0.05) 114 (0.16)
Multiple organ dysfunction syndrome 40 (0.87) 6 (0.12) 0 0 4 (0.02) 1 (0.00) 63 (0.09)
Multiple sclerosis 0 3 (0.06) 22 (0.37) 0 15 (0.08) 59 (0.16) 100 (0.14)
Multiple sclerosis relapse 0 1 (0.02) 5 (0.08) 0 18 (0.10) 32 (0.09) 56 (0.08)
Muscle spasms 4 (0.09) 39 (0.76) 88 (1.47) 3 (2.68) 118 (0.63) 184 (0.51) 444 (0.63)
Muscle tightness 1 (0.02) 12 (0.23) 14 (0.23) 1 (0.89) 23 (0.12) 14 (0.04) 68 (0.10)
Muscle twitching 2 (0.04) 7 (0.14) 41 (0.69) 1 (0.89) 26 (0.14) 32 (0.09) 111 (0.16)
Muscular weakness 17 (0.37) 68 (1.33) 231 (3.86) 1 (0.89) 352 (1.88) 137 (0.38) 833 (1.18)
Musculoskeletal chest pain 1 (0.02) 14 (0.27) 13 (0.22) 0 33 (0.18) 23 (0.06) 86 (0.12)
Musculoskeletal pain 2 (0.04) 2 (0.04) 12 (0.20) 1 (0.89) 25 (0.13) 97 (0.27) 140 (0.20)
Musculoskeletal stiffness 1 (0.02) 12 (0.23) 126 (2.11) 0 75 (0.40) 173 (0.48) 392 (0.56)
Myalgia 34 (0.74) 130 (2.54) 1041 (17.40) 3 (2.68) 578 (3.09) 1560 (4.33) 3381 (4.80)
Myasthenia gravis 1 (0.02) 7 (0.14) 17 (0.28) 0 16 (0.09) 28 (0.08) 71 (0.10)
Myelitis transverse 0 4 (0.08) 32 (0.53) 0 31 (0.17) 13 (0.04) 84 (0.12)
Myocardial infarction 154 (3.34) 193 (3.78) 4 (0.07) 0 191 (1.02) 80 (0.22) 649 (0.92)
Myocarditis 24 (0.52) 231 (4.52) 35 (0.58) 1 (0.89) 1293 (6.92) 348 (0.97) 1963 (2.78)
Nasal congestion 2 (0.04) 6 (0.12) 16 (0.27) 0 40 (0.21) 30 (0.08) 96 (0.14)
Nasopharyngitis 6 (0.13) 4 (0.08) 16 (0.27) 0 47 (0.25) 98 (0.27) 172 (0.24)
Nausea 84 (1.82) 264 (5.16) 834 (13.94) 3 (2.68) 1089 (5.83) 1798 (4.99) 4143 (5.88)
Neck pain 6 (0.13) 39 (0.76) 118 (1.97) 2 (1.79) 134 (0.72) 164 (0.46) 471 (0.67)
Nephrolithiasis 0 4 (0.08) 2 (0.03) 0 27 (0.14) 52 (0.14) 86 (0.12)
Nervous system disorder 3 (0.07) 2 (0.04) 18 (0.30) 0 21 (0.11) 13 (0.04) 61 (0.09)
Neuralgia 1 (0.02) 9 (0.18) 70 (1.17) 1 (0.89) 42 (0.22) 70 (0.19) 196 (0.28)
Neurological symptom 6 (0.13) 26 (0.51) 31 (0.52) 0 66 (0.35) 8 (0.02) 141 (0.20)
Neuropathy peripheral 0 5 (0.10) 49 (0.82) 0 31 (0.17) 314 (0.87) 409 (0.58)
Night sweats 1 (0.02) 12 (0.23) 23 (0.38) 0 37 (0.20) 79 (0.22) 156 (0.22)
Oedema 11 (0.24) 11 (0.22) 12 (0.20) 0 52 (0.28) 26 (0.07) 117 (0.17)
Oedema peripheral 9 (0.20) 19 (0.37) 32 (0.53) 0 84 (0.45) 65 (0.18) 214 (0.30)
Ophthalmic herpes zoster 0 1 (0.02) 5 (0.08) 0 7 (0.04) 54 (0.15) 67 (0.10)
Optic neuritis 0 0 16 (0.27) 0 21 (0.11) 29 (0.08) 67 (0.10)
Oral herpes 1 (0.02) 2 (0.04) 8 (0.13) 0 8 (0.04) 37 (0.10) 56 (0.08)
Oropharyngeal discomfort 0 10 (0.20) 3 (0.05) 0 21 (0.11) 15 (0.04) 52 (0.07)
Oropharyngeal pain 13 (0.28) 31 (0.61) 62 (1.04) 0 128 (0.69) 205 (0.57) 445 (0.63)
Oxygen saturation decreased 19 (0.41) 23 (0.45) 4 (0.07) 0 70 (0.37) 19 (0.05) 153 (0.22)
Pain 64 (1.39) 222 (4.34) 572 (9.56) 5 (4.46) 711 (3.80) 946 (2.63) 2575 (3.65)
Pain in extremity 38 (0.83) 248 (4.85) 639 (10.68) 5 (4.46) 534 (2.86) 1446 (4.02) 2950 (4.18)
Pain in jaw 2 (0.04) 11 (0.22) 19 (0.32) 0 35 (0.19) 23 (0.06) 93 (0.13)
Pain of skin 0 5 (0.10) 20 (0.33) 0 5 (0.03) 45 (0.12) 76 (0.11)
Painful respiration 3 (0.07) 15 (0.29) 5 (0.08) 0 45 (0.24) 7 (0.02) 78 (0.11)
Pallor 12 (0.26) 15 (0.29) 7 (0.12) 1 (0.89) 44 (0.24) 36 (0.10) 122 (0.17)
Palpitations 9 (0.20) 135 (2.64) 161 (2.69) 1 (0.89) 413 (2.21) 446 (1.24) 1184 (1.68)
Pancreatitis 2 (0.04) 13 (0.25) 3 (0.05) 0 48 (0.26) 29 (0.08) 96 (0.14)
Pancreatitis acute 0 11 (0.22) 0 0 56 (0.30) 7 (0.02) 77 (0.11)
Panic attack 1 (0.02) 4 (0.08) 24 (0.40) 0 12 (0.06) 22 (0.06) 66 (0.09)
Paraesthesia 2 (0.04) 106 (2.07) 292 (4.88) 0 414 (2.22) 507 (1.41) 1340 (1.90)
Paraesthesia oral 0 26 (0.51) 18 (0.30) 0 46 (0.25) 62 (0.17) 154 (0.22)
Paralysis 6 (0.13) 27 (0.53) 54 (0.90) 1 (0.89) 55 (0.29) 132 (0.37) 288 (0.41)
Parosmia 1 (0.02) 3 (0.06) 27 (0.45) 0 10 (0.05) 12 (0.03) 53 (0.08)
Periarthritis 0 0 28 (0.47) 0 4 (0.02) 20 (0.06) 52 (0.07)
Pericardial effusion 5 (0.11) 51 (1.00) 5 (0.08) 0 101 (0.54) 63 (0.17) 239 (0.34)
Pericarditis 5 (0.11) 105 (2.05) 17 (0.28) 0 465 (2.49) 409 (1.14) 1009 (1.43)
Peripheral coldness 11 (0.24) 17 (0.33) 17 (0.28) 0 26 (0.14) 37 (0.10) 111 (0.16)
Peripheral swelling 16 (0.35) 134 (2.62) 206 (3.44) 1 (0.89) 243 (1.30) 562 (1.56) 1191 (1.69)
Petechiae 3 (0.07) 31 (0.61) 7 (0.12) 0 78 (0.42) 22 (0.06) 145 (0.21)
Pharyngeal swelling 0 84 (1.64) 12 (0.20) 0 52 (0.28) 60 (0.17) 214 (0.30)
Photophobia 1 (0.02) 9 (0.18) 42 (0.70) 0 33 (0.18) 68 (0.19) 156 (0.22)
Platelet count decreased 7 (0.15) 24 (0.47) 2 (0.03) 1 (0.89) 41 (0.22) 10 (0.03) 90 (0.13)
Pleural effusion 22 (0.48) 39 (0.76) 9 (0.15) 0 134 (0.72) 4 (0.01) 226 (0.32)
Pleuritic pain 0 14 (0.27) 0 0 31 (0.17) 2 (0.01) 51 (0.07)
Pneumonia 145 (3.15) 102 (2.00) 14 (0.23) 0 515 (2.76) 231 (0.64) 1074 (1.52)
Pneumonia aspiration 19 (0.41) 9 (0.18) 1 (0.02) 0 17 (0.09) 2 (0.01) 52 (0.07)
Pneumonitis 4 (0.09) 11 (0.22) 1 (0.02) 0 25 (0.13) 8 (0.02) 51 (0.07)
Pollakiuria 4 (0.09) 5 (0.10) 13 (0.22) 0 17 (0.09) 17 (0.05) 57 (0.08)
Polymenorrhoea 0 0 22 (0.37) 1 (0.89) 7 (0.04) 59 (0.16) 89 (0.13)
Polymyalgia rheumatica 0 1 (0.02) 18 (0.30) 0 6 (0.03) 95 (0.26) 120 (0.17)
Postmenopausal haemorrhage 0 0 5 (0.08) 0 1 (0.01) 139 (0.39) 145 (0.21)
Presyncope 1 (0.02) 22 (0.43) 36 (0.60) 1 (0.89) 160 (0.86) 145 (0.40) 375 (0.53)
Productive cough 16 (0.35) 10 (0.20) 10 (0.17) 0 79 (0.42) 13 (0.04) 134 (0.19)
Pruritus 6 (0.13) 93 (1.82) 101 (1.69) 3 (2.68) 198 (1.06) 563 (1.56) 974 (1.38)
Pulmonary congestion 4 (0.09) 7 (0.14) 2 (0.03) 0 30 (0.16) 91 (0.25) 141 (0.20)
Pulmonary embolism 100 (2.17) 644 (12.60) 20 (0.33) 0 774 (4.14) 226 (0.63) 1786 (2.53)
Pulmonary infarction 3 (0.07) 28 (0.55) 1 (0.02) 0 22 (0.12) 9 (0.02) 65 (0.09)
Pulmonary mass 9 (0.20) 11 (0.22) 6 (0.10) 0 33 (0.18) 4 (0.01) 67 (0.10)
Pulmonary oedema 32 (0.69) 37 (0.72) 5 (0.08) 1 (0.89) 82 (0.44) 20 (0.06) 196 (0.28)
Pulmonary pain 0 11 (0.22) 11 (0.18) 0 16 (0.09) 14 (0.04) 52 (0.07)
Pulmonary thrombosis 10 (0.22) 92 (1.80) 7 (0.12) 0 89 (0.48) 19 (0.05) 220 (0.31)
Pyrexia 222 (4.82) 435 (8.51) 1325 (22.15) 13 (11.61) 2296 (12.29) 3316 (9.21) 7760 (11.01)
Rash 9 (0.20) 112 (2.19) 170 (2.84) 1 (0.89) 372 (1.99) 717 (1.99) 1396 (1.98)
Rash erythematous 1 (0.02) 20 (0.39) 25 (0.42) 0 47 (0.25) 185 (0.51) 282 (0.40)
Rash macular 1 (0.02) 6 (0.12) 26 (0.43) 0 19 (0.10) 54 (0.15) 107 (0.15)
Rash papular 0 5 (0.10) 4 (0.07) 0 8 (0.04) 53 (0.15) 71 (0.10)
Rash pruritic 1 (0.02) 10 (0.20) 21 (0.35) 0 46 (0.25) 130 (0.36) 208 (0.30)
Rectal haemorrhage 2 (0.04) 1 (0.02) 3 (0.05) 0 30 (0.16) 57 (0.16) 98 (0.14)
Renal failure 52 (1.13) 31 (0.61) 6 (0.10) 0 45 (0.24) 16 (0.04) 171 (0.24)
Renal impairment 10 (0.22) 5 (0.10) 6 (0.10) 0 32 (0.17) 37 (0.10) 99 (0.14)
Renal pain 1 (0.02) 1 (0.02) 19 (0.32) 0 10 (0.05) 44 (0.12) 75 (0.11)
Respiratory arrest 73 (1.59) 23 (0.45) 1 (0.02) 0 15 (0.08) 15 (0.04) 140 (0.20)
Respiratory disorder 13 (0.28) 9 (0.18) 11 (0.18) 0 18 (0.10) 7 (0.02) 61 (0.09)
Respiratory distress 31 (0.67) 31 (0.61) 3 (0.05) 0 58 (0.31) 55 (0.15) 191 (0.27)
Respiratory failure 102 (2.21) 46 (0.90) 4 (0.07) 0 90 (0.48) 6 (0.02) 258 (0.37)
Respiratory tract congestion 14 (0.30) 3 (0.06) 10 (0.17) 0 80 (0.43) 2 (0.01) 115 (0.16)
Restlessness 4 (0.09) 7 (0.14) 7 (0.12) 0 17 (0.09) 33 (0.09) 69 (0.10)
Retching 0 10 (0.20) 8 (0.13) 0 27 (0.14) 19 (0.05) 65 (0.09)
Retinal vein occlusion 0 2 (0.04) 19 (0.32) 0 5 (0.03) 28 (0.08) 54 (0.08)
Rhabdomyolysis 4 (0.09) 16 (0.31) 5 (0.08) 0 57 (0.31) 23 (0.06) 109 (0.15)
Rheumatoid arthritis 5 (0.11) 1 (0.02) 30 (0.50) 0 12 (0.06) 187 (0.52) 238 (0.34)
Rhinorrhoea 12 (0.26) 4 (0.08) 11 (0.18) 0 59 (0.32) 55 (0.15) 144 (0.20)
SARS-CoV-2 test positive 39 (0.85) 9 (0.18) 2 (0.03) 0 180 (0.96) 36 (0.10) 269 (0.38)
Seizure 37 (0.80) 99 (1.94) 52 (0.87) 2 (1.79) 326 (1.74) 1174 (3.26) 1735 (2.46)
Seizure like phenomena 5 (0.11) 6 (0.12) 5 (0.08) 0 24 (0.13) 64 (0.18) 106 (0.15)
Sensitive skin 0 1 (0.02) 12 (0.20) 0 4 (0.02) 53 (0.15) 72 (0.10)
Sensory disturbance 0 4 (0.08) 19 (0.32) 0 32 (0.17) 17 (0.05) 74 (0.10)
Sensory loss 0 9 (0.18) 20 (0.33) 0 23 (0.12) 10 (0.03) 64 (0.09)
Sepsis 85 (1.85) 47 (0.92) 6 (0.10) 0 182 (0.97) 14 (0.04) 346 (0.49)
Septic shock 51 (1.11) 19 (0.37) 0 0 25 (0.13) 2 (0.01) 100 (0.14)
Shock 19 (0.41) 14 (0.27) 1 (0.02) 0 12 (0.06) 18 (0.05) 71 (0.10)
Sinus tachycardia 4 (0.09) 10 (0.20) 7 (0.12) 0 54 (0.29) 5 (0.01) 83 (0.12)
Skin burning sensation 0 6 (0.12) 11 (0.18) 0 17 (0.09) 23 (0.06) 59 (0.08)
Skin discolouration 5 (0.11) 25 (0.49) 25 (0.42) 1 (0.89) 25 (0.13) 13 (0.04) 103 (0.15)
Skin disorder 0 1 (0.02) 77 (1.29) 0 6 (0.03) 12 (0.03) 96 (0.14)
Skin reaction 1 (0.02) 4 (0.08) 6 (0.10) 0 12 (0.06) 61 (0.17) 84 (0.12)
Skin warm 2 (0.04) 21 (0.41) 18 (0.30) 0 39 (0.21) 53 (0.15) 133 (0.19)
Sleep disorder 2 (0.04) 37 (0.72) 87 (1.45) 0 73 (0.39) 53 (0.15) 261 (0.37)
Somnolence 27 (0.59) 28 (0.55) 54 (0.90) 1 (0.89) 103 (0.55) 143 (0.40) 380 (0.54)
Speech disorder 7 (0.15) 40 (0.78) 55 (0.92) 1 (0.89) 113 (0.60) 27 (0.07) 253 (0.36)
Status epilepticus 1 (0.02) 8 (0.16) 2 (0.03) 0 13 (0.07) 27 (0.07) 52 (0.07)
Subarachnoid haemorrhage 14 (0.30) 33 (0.65) 1 (0.02) 0 35 (0.19) 0 84 (0.12)
Sudden death 105 (2.28) 0 0 0 0 0 105 (0.15)
Sudden hearing loss 0 2 (0.04) 59 (0.99) 0 13 (0.07) 80 (0.22) 154 (0.22)
Suicidal ideation 1 (0.02) 12 (0.23) 8 (0.13) 0 11 (0.06) 69 (0.19) 105 (0.15)
Superficial vein thrombosis 1 (0.02) 9 (0.18) 2 (0.03) 0 15 (0.08) 42 (0.12) 70 (0.10)
Supraventricular tachycardia 5 (0.11) 22 (0.43) 10 (0.17) 0 40 (0.21) 9 (0.02) 89 (0.13)
Swelling 8 (0.17) 30 (0.59) 72 (1.20) 0 107 (0.57) 289 (0.80) 510 (0.72)
Swelling face 3 (0.07) 55 (1.08) 40 (0.67) 0 102 (0.55) 90 (0.25) 301 (0.43)
Swollen tongue 2 (0.04) 80 (1.56) 14 (0.23) 0 90 (0.48) 54 (0.15) 246 (0.35)
Syncope 72 (1.56) 153 (2.99) 92 (1.54) 3 (2.68) 519 (2.78) 3771 (10.47) 4691 (6.65)
Systemic inflammatory response syndrome 5 (0.11) 12 (0.23) 1 (0.02) 0 36 (0.19) 18 (0.05) 75 (0.11)
Systemic lupus erythematosus 0 9 (0.18) 8 (0.13) 0 10 (0.05) 53 (0.15) 81 (0.11)
Tachycardia 19 (0.41) 112 (2.19) 65 (1.09) 1 (0.89) 390 (2.09) 249 (0.69) 849 (1.20)
Tachypnoea 9 (0.20) 9 (0.18) 1 (0.02) 0 72 (0.39) 5 (0.01) 100 (0.14)
Taste disorder 2 (0.04) 7 (0.14) 26 (0.43) 0 22 (0.12) 19 (0.05) 80 (0.11)
Tenderness 2 (0.04) 7 (0.14) 22 (0.37) 0 26 (0.14) 49 (0.14) 108 (0.15)
Tension headache 0 2 (0.04) 7 (0.12) 0 6 (0.03) 52 (0.14) 67 (0.10)
Thirst 0 5 (0.10) 9 (0.15) 0 17 (0.09) 32 (0.09) 66 (0.09)
Throat irritation 0 24 (0.47) 6 (0.10) 0 41 (0.22) 39 (0.11) 111 (0.16)
Throat tightness 2 (0.04) 89 (1.74) 15 (0.25) 0 76 (0.41) 65 (0.18) 253 (0.36)
Thrombocytopenia 25 (0.54) 75 (1.47) 5 (0.08) 0 201 (1.08) 127 (0.35) 456 (0.65)
Thrombosis 52 (1.13) 198 (3.87) 41 (0.69) 1 (0.89) 247 (1.32) 662 (1.84) 1238 (1.76)
Tinnitus 0 26 (0.51) 408 (6.82) 1 (0.89) 64 (0.34) 159 (0.44) 668 (0.95)
Transient ischaemic attack 7 (0.15) 46 (0.90) 18 (0.30) 0 144 (0.77) 107 (0.30) 332 (0.47)
Tremor 15 (0.33) 85 (1.66) 148 (2.47) 0 237 (1.27) 239 (0.66) 744 (1.06)
Troponin increased 3 (0.07) 16 (0.31) 1 (0.02) 0 57 (0.31) 3 (0.01) 85 (0.12)
Tunnel vision 0 1 (0.02) 4 (0.07) 0 1 (0.01) 86 (0.24) 93 (0.13)
Unevaluable event 4 (0.09) 12 (0.23) 7 (0.12) 1 (0.89) 431 (2.31) 1 (0.00) 457 (0.65)
Unresponsive to stimuli 163 (3.54) 58 (1.13) 7 (0.12) 0 112 (0.60) 523 (1.45) 934 (1.32)
Urinary incontinence 2 (0.04) 12 (0.23) 15 (0.25) 0 34 (0.18) 13 (0.04) 81 (0.11)
Urinary retention 4 (0.09) 8 (0.16) 4 (0.07) 0 34 (0.18) 36 (0.10) 88 (0.12)
Urinary tract infection 32 (0.69) 23 (0.45) 11 (0.18) 0 173 (0.93) 40 (0.11) 300 (0.43)
Urticaria 0 86 (1.68) 63 (1.05) 1 (0.89) 182 (0.97) 307 (0.85) 650 (0.92)
Uveitis 0 0 7 (0.12) 0 2 (0.01) 44 (0.12) 54 (0.08)
Vaccination complication 17 (0.37) 32 (0.63) 34 (0.57) 0 97 (0.52) 38 (0.11) 229 (0.32)
Vaccination failure 12 (0.26) 6 (0.12) 0 0 61 (0.33) 694 (1.93) 781 (1.11)
Vaccination site erythema 0 6 (0.12) 77 (1.29) 0 59 (0.32) 193 (0.54) 337 (0.48)
Vaccination site inflammation 0 0 8 (0.13) 0 6 (0.03) 43 (0.12) 57 (0.08)
Vaccination site movement impairment 0 1 (0.02) 25 (0.42) 0 7 (0.04) 17 (0.05) 51 (0.07)
Vaccination site oedema 0 1 (0.02) 34 (0.57) 0 9 (0.05) 61 (0.17) 105 (0.15)
Vaccination site pain 8 (0.17) 21 (0.41) 193 (3.23) 0 105 (0.56) 332 (0.92) 668 (0.95)
Vaccination site pruritus 0 4 (0.08) 38 (0.64) 0 15 (0.08) 97 (0.27) 154 (0.22)
Vaccination site rash 0 0 9 (0.15) 0 10 (0.05) 73 (0.20) 92 (0.13)
Vaccination site reaction 0 4 (0.08) 11 (0.18) 0 27 (0.14) 59 (0.16) 102 (0.14)
Vaccination site swelling 2 (0.04) 7 (0.14) 46 (0.77) 0 51 (0.27) 129 (0.36) 239 (0.34)
Vaccination site warmth 0 2 (0.04) 26 (0.43) 0 18 (0.10) 85 (0.24) 131 (0.19)
Vaccine breakthrough infection 24 (0.52) 1 (0.02) 0 0 149 (0.80) 73 (0.20) 262 (0.37)
Vaginal haemorrhage 1 (0.02) 12 (0.23) 9 (0.15) 5 (4.46) 32 (0.17) 92 (0.26) 151 (0.21)
Vasculitis 3 (0.07) 6 (0.12) 1 (0.02) 0 28 (0.15) 14 (0.04) 57 (0.08)
Venous thrombosis 1 (0.02) 15 (0.29) 3 (0.05) 0 15 (0.08) 15 (0.04) 53 (0.08)
Venous thrombosis limb 0 8 (0.16) 5 (0.08) 0 16 (0.09) 31 (0.09) 61 (0.09)
Ventricular extrasystoles 0 6 (0.12) 11 (0.18) 0 31 (0.17) 20 (0.06) 71 (0.10)
Ventricular fibrillation 20 (0.43) 23 (0.45) 1 (0.02) 0 12 (0.06) 0 64 (0.09)
Ventricular tachycardia 14 (0.30) 31 (0.61) 2 (0.03) 0 39 (0.21) 19 (0.05) 110 (0.16)
Vertigo 2 (0.04) 30 (0.59) 167 (2.79) 0 160 (0.86) 198 (0.55) 565 (0.80)
Vestibular neuronitis 0 2 (0.04) 9 (0.15) 0 35 (0.19) 12 (0.03) 59 (0.08)
Vision blurred 6 (0.13) 33 (0.65) 122 (2.04) 2 (1.79) 135 (0.72) 160 (0.44) 463 (0.66)
Visual field defect 0 5 (0.10) 19 (0.32) 0 22 (0.12) 4 (0.01) 53 (0.08)
Visual impairment 2 (0.04) 29 (0.57) 106 (1.77) 0 121 (0.65) 80 (0.22) 348 (0.49)
Vomiting 102 (2.21) 221 (4.32) 277 (4.63) 2 (1.79) 902 (4.83) 786 (2.18) 2372 (3.36)
Walking aid user 6 (0.13) 9 (0.18) 30 (0.50) 0 20 (0.11) 0 68 (0.10)
Weight decreased 7 (0.15) 17 (0.33) 28 (0.47) 0 55 (0.29) 26 (0.07) 138 (0.20)
Wheezing 9 (0.20) 36 (0.70) 9 (0.15) 0 84 (0.45) 45 (0.12) 193 (0.27)