Enhanced passive safety surveillance of the quadrivalent inactivated split-virion influenza vaccine (IIV4) in Finland during the 2019/20 influenza season

Table 1 Adverse drug reaction rates stratified by age, reported within 7 days of vaccination

	VC distribution (n) (%)	Vaccinees reporting rate (n)	Suspected reactions (n)	% Suspected reactions	95% CI
(All ages)^a
ADR		38	117	12.46	10.41, 14.74
PRAC^b		36	77	8.20	6.53, 10.14
Other^c		21	40	4.26	3.06, 5.76
6 months to 6 years of age ADR	1 (0.1)	0	0	0.0	0.00, 97.50
6–13 years of age ADR	7 (0.7)	0	0	0.0	0.00, 40.96
13–18 years of age ADR	9 (1.0)	0	0	0.0	0.00, 33.63
18–65 years of age ADR	884 (94.2)	37	111	12.56	10.44, 14.92
>65 years of age ADR	37 (3.9)	1	6	16.22	6.19, 32.01

^aAge information was missing for one participant
^bPRAC ADRs of interest for this EPSS are defined according to the ‘Interim guidance on enhanced safety surveillance for seasonal influenza vaccine in the EU’ adopted by PRAC on April 10, 2014 (EMA/PRAC/222346/2014)
^cOther ADRs are events that do not fall into PRAC ADRs of interest or identified/potential risk
Abbreviations: ADR adverse drug reaction; CI confidence interval; EMA European Medicines Agency; EPSS Enhanced Passive Safety Surveillance; PRAC Pharmacovigilance Risk Assessment Committee; VC vaccination card

ISSN: 1471-2458