Table 5 Outcome events.

Total reports

36,715

4221

314

Outcome events, n (%)

 Death

6700 (18.25)

732 (17.34)

42 (13.38)

 Disability

226 (0.62)

44 (1.04)

4 (1.27)

 Hospitalization-initial or prolonged

13,542 (36.88)

1317 (31.20)

138 (43.95)

 Life-threatening

2507 (6.83)

233 (5.52)

30 (9.55)

 Other serious (important medical event)

12,742 (34.71)

1584 (37.53)

100 (31.85)

 Unknown

998 (2.72)

311 (7.36)

(0)