Tolerability of trivalent inactivated influenza vaccine among pregnant women, 2015

Table 2 Frequency of adverse events occurring within four weeks of influenza vaccination among 305 pregnant women, Bangkok, Thailand^{a, b}

Symptoms	Pregnant women, Bangkok		Comparison group 1^d	Comparison group 2^d
Symptoms	Frequency	% (95% confidence interval	%	%
One or more adverse events	134	44 (38.0, 50.0)	NR	NR
Pain/soreness at injection site	74	24.3 (19.4, 29.1)	36.4	1–10
Redness at injection site	18	5.9 (3.2, 8.6)	1.9	1–10
Induration/swelling at injection site	7	2.3 (0.6, 4.0)	2.1	1–10
Body temperature >37.5 °C^c	4	1.3 (0, 2.6)	1.6	1–10
Headache	45	14.8 (10.8, 18.8)	15.9	1–10
General weakness	50	16.4 (12.4, 21.0)	15.8	1–10
Muscle ache	49	16.1 (11.9, 20.2)	16.4	1–10
Nausea	17	5.6 (3.0, 8.2)	NR	NR
Pruritus	10	3.3 (1.3, 5.3)	NR	NR
Rash	2	0.7 (0, 2.3)	NR	NR

Abbreviations: NR not reported
^aAll except rash were solicited adverse events
^bIn addition to the adverse events shown in the Table 2, two women had serious adverse events (decreased fetal movement and chorioamniitis) that were judged unrelated to vaccine
^cExcluding one participant who reported a fever onset 25 days after vaccination whose body temperature was not measured
^dComparison group data from Fluarix Quadrivalent package insert [26] (group 1) and Influvac Trivalent package insert [20] (group 2)

ISSN: 1471-2393