Table 1.
Baseline characteristics of COVID-19 vaccine-related reports of acute polyneuropathies in VigiBase as of 15 August 2021
| Characteristic | Tozinameran, N (%) | Elosameran, N (%) | ChAdOx1 nCoV-19, N (%) | Ad26.CoV2.S, N (%) |
|---|---|---|---|---|
| Number of cases | 1058 (42.3) | 284 (11.4) | 882 (35.3) | 275 (11.0) |
| Region of origin | ||||
| Australia | 11 (1.0) | 78 (8.8) | ||
| European Union | 293 (27.7) | 44 (15.5) | 345 (39.1) | 89 (32.4) |
| United Kingdom | 47 (4.4) | 3 (1.1) | 358 (0.6) | |
| United States of America | 640 (60.5) | 229 (80.6) | 170 (61.8) | |
| Central/South America | 47 (4.4) | 1 (0.4) | 77 (8.7) | 13 (4.7) |
| Other regionsa | 20 (1.9) | 7 (2.5) | 24 (2.7) | 3 (1.1) |
| Sex | ||||
| Female | 531 (50.2) | 148 (52.1) | 398 (45.1) | 108 (39.3) |
| Male | 525 (49.6) | 136 (47.9) | 472 (53.5) | 166 (60.4) |
| Unknown | 2 (0.2) | 12 (1.4) | 1 (0.4) | |
| Age (years) | ||||
| Median [IQR] | 54 [38–68] | 57 [44–68] | 59 [50–65] | 56 [46–62] |
| 12–29 | 90 (8.5) | 25 (8.8) | 15 (1.7) | 14 (5.1) |
| 30–49 | 258 (24.4) | 73 (24.4) | 179 (20.3) | 75 (27.3) |
| 50–69 | 262 (24.8) | 118 (41.5) | 511 (57.9) | 164 (59.6) |
| 70–89 | 175 (16.5) | 65 (22.9) | 135 (15.3) | 20 (7.3) |
| 90+ | 9 (0.9) | 40 (0.5) | ||
| Not recorded | 264 (25.0) | 3 (1.1) | 38 (4.3) | 2 (0.7) |
| Dose number involved | ||||
| First dose | 251 (23.7) | 56 (19.7) | 531 (60.3) | 275 (100) |
| Second dose | 102 (9.6) | 16 (5.6) | 64 (7.2) | |
| Unknown | 705 (66.7) | 212 (74.6) | 287 (32.6) | |
| Time to onset (days), median [IQR] | ||||
| After dose 1 | 9 [3–16] | 10 [3–19] | 14 [9–20] | 14 [7–19] |
| After dose 2 | 11 [3–19] | 13 [3–24] | 10 [2–18] | |
| D ose number unknown | 7 [2–16] | 8 [3–17] | 14 [9–20] | |
| ≤ 21 days after any dose | 888 (83.9) | 219 (77.1) | 709 (80.4) | 228 (82.9) |
| Type of polyneuropathy | ||||
| GBS | 1039 (98.2) | 280 (98.6) | 852 (96.6) | 274 (99.6) |
| MFS | 19 (1.8) | 4 (1.4) | 30 (3.4) | 1 (0.4) |
| Facial palsy | 41 (3.9) | 21 (7.4) | 118 (13.4) | 61 (22.2) |
| Recent other immunizations | 2 (0.2) | 2 (0.7) | 20 (2.3) | 0 (0) |
| Outcome at the time of recording | ||||
| Recovery | 69 (6.5) | 21 (7.4) | 43 (4.9) | 20 (7.3) |
| Recovery with sequelae | 10 (0.9) | 2 (0.7) | 23 (2.6) | 7 (2.5) |
| Improvement | 131 (12.4) | 20 (7.0) | 305 (34.6) | 30 (10.9) |
| Death | 22 (2.1) | 2 (0.7) | 10 (1.1) | 1 (0.4) |
| Not recovered or unknown | 826 (78.1) | 239 (84.25) | 501 (56.8) | 217 (78.9) |
GBS Guillain Barré syndrome, IQR interquartile range, MFS Miller Fisher syndrome
aOther regions include Asia (18), North Africa (6), and other European countries (30)