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. 2023 May 5;21:100497. doi: 10.1016/j.lana.2023.100497

Table 2.

Overall distribution and characterization of adverse events, according to dose and study group (reported from the beginning of the study until 14 days after completing the vaccination schedule).

Variable DOSE 1
DOSE 2
DOSE 3
Placebo Abdala Total Placebo Abdala Total Placebo Abdala Total
N 24,144 24,146 48,290 23,826 23,794 47,620 23,602 23,557 47,159
Subjects with adverse events 3000 (12.4%) 3177 (13.2%) 6177 (12.8%) 1749 (7.3%) 1983 (8.3%) 3732 (7.8%) 579 (2.5%) 639 (2.7%) 1218 (2.6%)
Total of adverse events (15,937) 4318 (48.7%) 4545 (51.3%) 8863 (55.6%) 2442 (46.0%) 2861 (54.0%) 5303 (33.3%) 838 (47.3%) 933 (52.7%) 1771 (11.1%)
Intensity
 Mild 3942 (91.3%) 4166 (91.7%) 8108 (91.5%) 2208 (90.4%) 2598 (90.8%) 4806 (90.6%) 719 (85.8%) 781 (83.7%) 1500 (84.7%)
 Moderate 371 (8.6%) 366 (8.1%) 737 (8.3%) 230 (9.4%) 260 (9.1%) 490 (9.2%) 114 (13.6%) 150 (16.1%) 264 (14.9%)
 Severe (Grade 3) 2 (0.04%) 1 (0.02%) 3 (0.03%) 0 0 0 5 (0.6%) 2 (0.2%) 7 (0.4%)
 Serious (Grade 4) 2 (0.04%) 1 (0.02%) 3 (0.03%) 0 1 (0.03%) 1 (0.01%) 0 0 0
 Serious (Grade 5) 1 (0.02%) 3 (0.07%) 4 (0.05%) 4 (0.2%) 2 (0.07%) 6 (0.1%) 0 0 0
Causality (WHO)
 Inconsistent with vaccination 2871 (66.5%) 2849 (62.7%) 5720 (64.5%) 1632 (66.8%) 1746 (61.0%) 3378 (63.7%) 588 (70.2%) 561 (60.1%) 1149 (64.9%)
 Indeterminate 596 (13.8%) 614 (13.5%) 1210 (13.7%) 334 (13.7%) 377 (13.2%) 711 (13.4%) 97 (11.6%) 108 (11.6%) 205 (11.6%)
 Consistent with vaccination 851 (19.7%) 1082 (23.8%) 1933 (21.8%) 476 (19.5%) 738 (25.8%) 1214 (22.9%) 153 (18.3%) 264 (28.3%) 417 (23.5%)
Action taken
 None 2817 (65.2%) 3025 (66.6%) 5842 (65.9%) 1629 (66.7%) 1962 (68.6%) 3591 (67.7%) 584 (69.7%) 628 (67.3%) 1212 (68.4%)
 Non-drug therapy 132 (3.1%) 133 (2.9%) 265 (3.0%) 44 (1.8%) 52 (1.8%) 96 (1.8%) 9 (1.1%) 16 (1.7%) 25 (1.4%)
 Drug therapy 1372 (31.8%) 1385 (30.5%) 2757 (31.1%) 762 (31.2%) 842 (29.4%) 1604 (30.2%) 241 (28.8%) 289 (31.0%) 530 (29.9%)
 Hospitalization 1 (0.02%) 0 1 (0.01%) 3 (0.1%) 0 3 (0.05%) 4 (0.5%) 0 4 (0.2%)
 Withdrawal from study 6 (0.1%) 11 (0.2%) 17 (0.2%) 4 (0.2%) 5 (0.2%) 9 (0.2%) 0 0 0
Outcome
 Completely resolved 4277 (99.1%) 4499 (99.0%) 8776 (99.0%) 2421 (99.1%) 2845 (99.4%) 5266 (99.3%) 822 (98.1%) 919 (98.5%) 1741 (98.3%)
 Resolved with sequelae 4 (0.09%) 4 (0.09%) 8 (0.09%) 2 (0.08%) 2 (0.07%) 4 (0.07%) 0 0 0
 Getting better 28 (0.6%) 27 (0.6%) 55 (0.6%) 11 (0.5%) 9 (0.3%) 20 (0.4%) 12 (1.4%) 10 (1.1%) 22 (1.2%)
 Present and unchanged 8 (0.2%) 11 (0.2%) 19 (0.3%) 4 (0.2%) 3 (0.1%) 7 (0.1%) 4 (0.5%) 4 (0.4%) 8 (0.5%)
 Worsening 0 1 (0.02%) 1 (0.01%) 0 0 0 0 0 0
 Death from adverse event 1 (0.02%) 3 (0.07%) 4 (0.05%) 4 (0.2%) 2 (0.07%) 6 (0.1%) 0 0 0

The variable Action taken was tabulated following a hierarchical structure, to ensure that its categories are exclusive. Levels of this variable are ordered from least to most “drastic” measures: None, Non-pharmacological therapy, Pharmacological therapy, Hospitalization and Withdrawal from the study.