Enhanced passive safety surveillance of three marketed influenza vaccines in the UK and the Republic of Ireland during the 2017/18 season

Figures & data

Table 1. Overall frequencies of suspected adverse reactions (ARs) and adverse events of interest (AEIs) occurring within 7 days by vaccine and age group.

		Participants reporting ≥1 AR		#ARs		Participants reporting ≥1 AEI^a		#AEIs^a
	Safety report cards distributed	n	% (95% CI)	n	%	n	% (95% CI)	n	%
IIV3-ID
≥60 y	977	27	2.8 (1.7, 3.8)	71	7.3	21	2.1 (1.2, 3.1)	36	3.7
Total	979^b	27	2.8 (1.7, 3.8)	71	7.3	21	2.1 (1.2, 3.1)	36	3.7
IIV3
6 mo−5 y	7	0	0.0 (−)	0	0.0	0	0.0 (−)	0	0.0
6−12 y	13	0	0.0 (−)	0	0.0	0	0.0 (−)	0	0.0
13−17 y	6	0	0.0 (−)	0	0.0	0	0.0 (−)	0	0.0
18−65 y	326	5	1.5 (0.5, 3.5)	9	2.8	4	1.2 (0.3, 3.1)	6	1.8
>65 y	653	8	1.2 (0.4, 2.1)	21	3.2	5	0.8 (0.3, 1.8)	7	1.1
Total	1005	13	1.3 (0.6, 2.0)	30	3.0	9	0.9 (0.3, 1.5)	13	1.3
IIV4
3−5 y	0	0	0.0 (−)	0	0.0	0	0.0 (−)	0	0.0
6−12 y	4	0	0.0 (−)	0	0.0	0	0.0 (−)	0	0.0
13−17 y	6	0	0.0 (−)	0	0.0	0	0.0 (−)	0	0.0
18−65 y	276	5	1.8 (0.6, 4.2)	12	4.3	4	1.4 (0.4, 3.7)	7	2.5
>65 y	671	13	1.9 (0.9, 3.0)	27	4.0	10	1.5 (0.6, 2.4)	12	1.8
Total	957	18	1.9 (1.0, 2.7)	39	4.1	14	1.5 (0.7, 2.2)	19	2.0

Abbreviations: IIV3, trivalent split-virion inactivated influenza vaccine; IIV3-ID, intradermally administered trivalent split-virion inactivated influenza vaccine; IIV4, quadrivalent split-virion inactivated influenza vaccine; −, not reported

^a AEIs were defined according to the Pharmacovigilance Risk Assessment Committee²

^b Two participants had ages outside the indicated age range; neither reported an AR during the surveillance period

Table 2. Frequencies of all adverse reactions (ARs) for IIV3-ID and IIV3 reported during the 2017/18 EPSS and comparison with the frequencies reported during the 2016/17 EPSS.

ARs	IIV3-ID				IIV3
	2017/18 (N = 979)		2016/17 (N = 1000)		2017/18 (N = 1005)		2016/17 (N = 962)
	n	% (95% CI)	n	% (95% CI)	n	% (95% CI)	n	% (95% CI)
Participants reporting ≥1 suspected AR	28	2.9 (1.8, 3.9)	21	2.1 (1.2, 3.0)	14	1.4 (0.7, 2.1)	17	1.8 (0.9, 2.6)
Participants reporting ≥1 AEI	22	2.2 (1.3, 3.2)	17	1.7 (0.9, 2.5)	10	1.0 (0.4, 1.6)	12	1.2 (0.5, 1.9)
Suspected ARs^a	77	7.9	103	10.3	40	4.0	59	6.1
AEIs^a, b	37	3.8	44	4.4	17	1.7	28	2.9
Headache	1	0.1 (0.0, 0.6)	6	0.6 (0.1, 1.1)	3	0.3 (0.1, 0.9)	4	0.4 (0.1, 1.0)
Feeling of body temperature change	2	0.2 (0.0, 0.7)	0	0.0 (0.0, 0.4)	−	−	−	−
Malaise	1	0.1 (0.0, 0.6)	6	0.6 (0.1, 1.1)	2	0.2 (0.0, 0.7)	4	0.4 (0.1, 1.0)
Nausea	−	−	−	−	2	0.2 (0.0, 0.7)	0	0.0 (0.0, 0.4)
Vaccination site erythema	3	0.3 (0.1, 0.9)	6	0.6 (0.1, 1.1)	−	−	−	−
Vaccination site inflammation	10	1.0 (0.4, 1.7)	3	0.3 (0.1, 0.9)	6	0.6 (0.1, 1.1)	0	0.0 (0.0, 0.4)
Vaccination site pruritus	6	0.6 (0.1, 1.1)	2	0.2 (0.0, 0.7)	−	−	−	−
Vaccination site reaction	3	0.3 (0.1, 0.9)	1	0.1 (0.0, 0.6)	−	−	−	−
Other ARs^b
Asthenopia	2	0.2 (0.0, 0.7)	0	0.0 (0.0, 0.4)	−	−	−	−
Inflammation	2	0.2 (0.0, 0.7)	0	0.0 (0.0, 0.4)	−	−	−	−
Lethargy	1	0.1 (0.0, 0.6)	0	0.0 (0.0, 0.4)	2	0.2 (0.0, 0.7)	1	0.1 (0.0, 0.6)
Nasopharyngitis	2	0.2 (0.0, 0.7)	1	0.1 (0.0, 0.6)	−	−	−	−
Oropharyngeal pain	3	0.3 (0.1, 0.9)	8	0.8 (0.2, 1.4)	2	0.2 (0.0, 0.7)	1	0.1 (0.0, 0.6)
Rhinorrhea	2	0.2 (0.0, 0.7)	4	0.4 (0.1, 1.0)	−	−	−	−
Hyperhidrosis	3	0.3 (0.1, 0.9)	0	0.0 (0.0, 0.4)	2	0.2 (0.0, 0.7)	0	0.0 (0.0, 0.4)

Abbreviations: AEI, adverse event of interest; CI, confidence interval; IIV3, trivalent split-virion inactivated influenza vaccine; IIV3-ID, intradermally administered trivalent split-virion inactivated influenza vaccine; −, none reported

^a Since the proportion of total reported ARs and AEIs could theoretically be >100%, 95% CIs were not calculated

^b Only ARs reported in ≥2 participants in NH Season 2017/18 are shown

Table 3. Frequencies of all adverse reactions (ARs) reported for IIV4 during the 2017/18 EPSS and comparison with the frequency categories listed in the SmPC.

		18–65 y (N = 276)				>65 y (N = 671)
	2017/18				2017/18
	n	% (95% CI)	Category	SmPC^d category	n	% (95% CI)	Category	SmPC^d category
Participants reporting ≥1 suspected AR	5	1.8 (0.6, 4.2)			15	2.2 (1.1, 3.4)
Participants reporting ≥1 AEI	4	1.4 (0.4, 3.7)			12	1.8 (0.8, 2.8)
Suspected ARs^a	13	4.7			43	6.4
AEIs^a, b	7	2.5			18	2.7
Fever^c	1	0.4 (0.0, 2.0)	Uncommon	Common	2	0.3 (0.0, 1.1)	Uncommon	Uncommon
Headache	2	0.7 (0.1, 2.6)	Uncommon	Very common	5	0.7 (0.2, 1.7)	Uncommon	Very common
Vaccination site inflammation	1	0.4 (0.0, 2.0)	Uncommon	Mixed^e	2	0.3 (0.0, 1.1)	Uncommon	Mixed^e
Malaise	1	0.4 (0.0, 2.0)	Uncommon	Very common	1	0.1 (0.0, 0.8)	Uncommon	Common
Myalgia	0	0.0 (−)	−	Very common	2	0.3 (0.0, 1.1)	Uncommon	Very common
Other ARs^b
Fatigue	1	0.4 (0.0, 2.0)	Uncommon	Uncommon	2	0.3 (0.0, 1.1)	Uncommon	Uncommon
Feeling hot	0	0.0 (−)	−	−	2	0.3 (0.0, 1.1)	Uncommon	−
Pain	1	0.4 (0.0, 2.0)	Uncommon	−	1	0.1 (0.0, 0.8)	Uncommon	−
Nasopharyngitis	0	0.0 (−)	−	−	2	0.3 (0.0, 1.1)	Uncommon	−
Pain in extremity	1	0.4 (0.0, 2.0)	Uncommon	−	1	0.1 (0.0, 0.8)	Uncommon	−
Dizziness	0	0.0 (−)	−	Rare	2	0.3 (0.0, 1.1)	Uncommon	Uncommon
Lethargy	0	0.0 (−)	−	Rare	2	0.3 (0.0, 1.1)	Uncommon	Rare
Oropharyngeal pain	0	0.0 (−)	−	−	3	0.4 (0.1, 1.3)	Uncommon	−
Rhinorrhea	0	0.0 (−)	−	−	2	0.3 (0.0, 1.1)	Uncommon	−

Abbreviations: AEI, adverse event of interest; CI, confidence interval; IIV4, quadrivalent split-virion inactivated influenza vaccine; PRAC, Pharmacovigilance Risk Assessment Committee; SmPC, Summary of Product Characteristics; −, not reported

^a Since the proportion of total reported ARs and AEIs could theoretically be >100%, 95% CIs were not calculated

^b Only ARs reported in ≥2 participants in NH Season 2017/18 are shown

^c Includes feeling of body temperature change or pyrexia

^d Frequencies: very common (≥10%); common (≥1% to <10%); uncommon (≥0.1% to <1%); rare (≥0.01% to <0.1%); very rare (<0.01%)

^e Pain (very common; ≥10%), erythema and swelling (common; ≥1% to <10%), warmth (uncommon; ≥0.1% to <1%)

European Medicines Agency. Pharmacovigilance risk assessment committee (PRAC). Interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU. London; 2014 April 10 [ accessed 2018 May 28]. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/04/WC500165492.pdf.

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