Table 1.
Baseline characteristics of participants vaccinated against COVID‐19 and influenza reported to VigiBase for any adverse event following immunization (AEFI)
| COVID‐19 vaccine (n = 18 755) | Influenza vaccine (n = 27 895) | |
|---|---|---|
| Regions reporting | ||
| Americas | 6947/18 755 (37.0) | 17 730/27 895 (63.6) |
| Europe | 11 787/18 755 (62.9) | 8380/27 895 (30.0) |
| Australia | 0/18 755 (0.0) | 1377/27 895 (4.8) |
| Asia | 21/18 755 (0.1) | 327/27 895 (1.2) |
| Africa | 0/18 755 (0.0) | 81/27 895 (0.4) |
| Report from clinical trials | 94/18 755 (0.5) | 1326/28 750 (4.8) |
| Reporting months | ||
| 2020.01–2020.10 | 0/18 755 (0.0) | 16 338/27 895 (58.6) |
| 2020.11 | 1/18 755 (0.0) | 2302/27 895 (8.2) |
| 2020.12 | 2087/18 755 (11.1) | 9217/27 895 (32.0) |
| 2021.01 | 16 667/18 755 (88.9) | 898/27 895 (3.2) |
| Reporter | ||
| Health care professional | 8459/18 755 (45.1) | 4054/27 895 (14.5) |
| Non‐health care professional | 3364/18 755 (17.9) | 6009/27 895 (21.5) |
| Unreported | 6942/18 755 (37.0) | 17 832/27 895 (64.0) |
| Age groups | ||
| <45 years | 9389/18 755 (50.1) | 10 703/27 895 (38.3) |
| 45–64 years | 6422/18 755 (34.2) | 6504/27 895 (23.3) |
| 65–74 years | 449/18 755 (2.4) | 5132/27 895 (18.4) |
| ≥75 years | 1282/18 755 (6.8) | 2777/27 895 (10.0) |
| Unreported | 1213/18 755 (6.5) | 2779/27 895 (10.0) |
| Sex | ||
| Male | 3838/18 755 (20.5) | 9263/27 895 (33.2) |
| Female | 14 514/18 755 (77.4) | 18 262/27 895 (65.5) |
| Unreported | 403/18 755 (2.1) | 370/27 895 (1.3) |
| Serious AEFIs | 3737/18 755 (19.9) | 3343/27 573 (12.1) |
| Outcomes | n = 13 058 | n = 14 317 |
| Deathsa | 119/13 058 | 113/14371 |
| Time to AEFIs onset | n = 10 876 | n = 14 925 |
| Median days (IQR) | 1.0 (0.0–1.0) | 0.0 (0.0–0.0) |
Abbreviations: AEFIs, adverse events following immunization; IQR, interquartile range.
As denominator, all vaccinated participants with AEFIs reported rather than all vaccinated persons were used; we did not present percentile estimations given that they must be larger than those observed in real‐world settings. The AEFIs for the COVID‐19 and influenza vaccine were extracted from January 2020 to January 17, 2021. Values are presented as n (%) or n/N (%), unless otherwise indicated. Severe AEFI was defined as AEFI that is life‐threatening, causes persistent or significant disability, requires hospitalization (first or prolonged), or results in death.