Table 3.

Disproportional reporting for preferred term ‘drug exposure to patient of inappropriate age’ and ‘incorrect route of drug administration’ ^* after Flucelvax® using Empirical Bayesian data mining during the 2014-2015 influenza season

PREFERED TERM NAME	N	E	OE	EBGM	EB05
INFLUENZA (SEASONAL) (FLUCELVAX 14-15)
Drug administered to patient of inappropriate age	34	2.58	13.2	12.47	9.35
Incorrect route of drug administration	7	0.41	17.17	12.18	5.89

n = Observed number of reports containing both the vaccine and symptom

E = Expected number of reports containing both the vaccine and symptom

OE = Ratio of n over E

EBGM = Empirical Bayes Geometric Mean estimate of OE (using the DuMouchel model) [ref 14]

EB05 = 90% lower confidence bound on EBGM (5th percentile of posterior)

^*‘Drug administered to patient of inappropriate age’ is a vaccination error PT which in this case denotes administration of Flucelvax® to persons less than 18 years in whom the vaccine is not recommended. This PT was disproportionally reported during the 2013-2014 season as well. ‘Incorrect route of drug administration’ is a vaccination error which refers to the incorrect administration of another vaccine, Tdap, given concomitantly with Flucelvax® on the same visit