Characteristics | Total reports, N. (%) | Reports by the healthcare professionals, N. (%) |
---|---|---|
540 | 213 | |
Gender | ||
 F | 263 (48.70) | 96 (45.07) |
 M | 229 (42.41) | 90 (42.25) |
 Unknown | 48 (8.89) | 27 (12.68) |
Age group (years) | ||
  < 18 | 74 (13.70) | 41 (19.25) |
 18–44 | 128 (23.70) | 60 (28.17) |
 45–64 | 131 (24.26) | 43 (20.19) |
 65–74 | 22 (4.07) | 8 (3.76) |
 75–84 | 10 (1.85) | 2 (0.94) |
  > 85 | 3 (0.56) | 2 (0.94) |
 Unknown | 172 (31.85) | 57 (26.76) |
Reporting Area | ||
 Asia | 67 (12.41) | 46 (21.60) |
 Europe | 91 (16.85) | 51 (23.94) |
 North America | 352 (65.19) | 102 (47.89) |
 Oceania | 2 (0.37) | – |
 South America | 4 (0.74) | 2 (0.94) |
 Unknown | 24 (4.44) | 12 (5.63) |
Reporters | ||
 Consumer | 249 (46.11) | – |
 Lawyer | 6 (1.11) | – |
 Other health professionals | 99 (18.33) | 99 (46.48) |
 Physician | 98 (18.15) | 98 (46.01) |
 Pharmacist | 16 (2.96) | 16 (7.51) |
 Unknown | 72 (13.33) | – |
Reporting Year | ||
 2004 | 18 (3.33) | 10 (4.69) |
 2005 | 11 (2.04) | 5 (2.35) |
 2006 | 20 (3.70) | 4 (1.88) |
 2007 | 9 (1.67) | 3 (1.41) |
 2008 | 13 (2.41) | 6 (2.82) |
 2009 | 17 (3.15) | 6 (2.82) |
 2010 | 29 (5.37) | 14 (6.57) |
 2011 | 14 (2.59) | 3 (1.41) |
 2012 | 16 (2.96) | 5 (2.35) |
 2013 | 30 (5.56) | 12 (5.63) |
 2014 | 55 (10.19) | 19 (8.92) |
 2015 | 30 (5.56) | 13 (6.10) |
 2016 | 50 (9.26) | 25 (11.74) |
 2017 | 36 (6.67) | 17 (7.98) |
 2018 | 66 (12.22) | 43 (20.19) |
 2019 | 36 (6.67) | 11 (5.16) |
 2020 | 48 (8.89) | 9 (4.23) |
 2021 | 39 (7.22) | 7 (3.29) |
 Unknown | 3 (0.56) | 1 (0.47) |
Outcome | ||
 Congenital anomaly | 2 (0.52) | – |
 Death | 9 (2.33) | 7 (4.00) |
 Disability | 51 (13.21) | 11 (6.29) |
 Hospitalization | 146 (37.82) | 75 (42.86) |
 Life-threatening | 55 (14.25) | 35 (20.00) |
 Other serious (important medical events) | 297 (76.94) | 134 (76.57) |
 Required intervention to prevent permanent impairment/damage | 10 (2.59) | 4 (2.29) |