Table 1.

Patient and report characteristics

	ADR identification task		Seriousness assessment task
	Development dataset (n = 10,403)	External validation dataset (n = 1230)	Development dataset (n = 4786)	External validation dataset (n = 404)
Patient age, years
Median (IQR)	51 (37–62)	51 (39–63)	41 (30–58)	39 (31–56)
Patient sex, n (%)
Female	8792 (84.5)	1056 (85.9)	3732 (78.0)	313 (77.5)
Encoded PTs per report, n
Median (IQR)	4 (2–6)	5 (3–7)	3 (1–5)	3 (2–6)
Reported drugs per report, n
Median (IQR)	1 (1–1)	1 (1–1)	1 (1–1)	1 (1–1)
Reports about vaccines, n (%)
Yes	275 (2.6)	13 (1.1)	275 (5.7)	13 (3.2)
Reports considered serious, n (%)
Yes	2454 (23.6)	136 (11.1)	1128 (23.6)	84 (20.8)

ADRs adverse drug reactions, IQR interquartile range, PTs Preferred Terms