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. 2021 Dec 27;11(1):463–483. doi: 10.1007/s40121-021-00571-y

Table 3.

Cumulative participants (%) reporting AEIs (italics) and/or other AEs post-dose 1 classified by MedDRA primary system organ class over the study period (safety set)

MedDRA primary system organ class (code)
 Preferred term (code)		 Belgium N = 306, n (%), 95% CI, LL-UL Germany N = 288, n (%), 95% CI, LL-UL Spain N = 460, n (%), 95% CI, LL-UL Total N = 1054, n (%), 95% CI, LL-UL
Any

113 (36.9)

8.8–74.1

97 (33.7)

6.6–72.8

188 (40.9)

0.0–99.9

398 (37.8)

29.0–47.2
General disorders and administration site conditions (10018065)

91 (29.7)

2.4–77.9

80 (27.8)

6.5–60.9

161 (35.0)

0.0–100.0

332 (31.5)

22.3–41.9
 Injection site pain (10022086)

74 (24.2)

0.7–78.2

52 (18.1)

5.5–39.0

142 (30.9)

0.0–99.8

268 (25.4)

16.7–35.8
 Injection site swelling (10053425)

12 (3.9)

2.0–6.8

39 (13.5)

1.2–45.0

37 (8.0)

0.0–99.4

88 (8.4)

3.5–16.2
 Fatigue (10016256)

16 (5.2)

2.4–9.8

27 (9.4)

0.9–31.7

28 (6.1)

0.0–98.7

71 (6.7)

3.2–12.1
 Injection site erythema (10022061)

8 (2.6)

1.1–5.1

37 (12.9)

4.9–25.7

24 (5.2)

0.0–51.2

69 (6.6)

3.0–12.1
 Chills (10008531)

7 (2.3)

0.1–9.8

10 (3.5)

0.4–12.7

13 (2.8)

0.0–91.8

30 (2.9)

1.3–5.5
 Pyrexia (10037660)

2 (0.7)

0.1–2.3

2 (0.7)

0.1–2.6

15 (3.3)

0.1–16.3

19 (1.8)

0.7–3.7
 Injection site pruritus (10022093)

2 (0.7)

0.0–7.1

1 (0.4)

0.0–4.6

0 (0.0)

0.0–0.8

3 (0.3)

0.0–1.3
 Injection site bruising (10022052); Injection site induration (10022075); Malaise (10025482)

n: 2; 2;

0 NR

n: 0; 0;

2 NR

n: 0; 0;

0 NR

2 (0.2)

each NR
 Swelling face (10042682); Injection site reaction (10022095)

n: 0;

1 NR

n: 1;

0 NR

 n: 0; 0 NR

1 (0.1)

each NR
Nervous system disorders (10029205)

20 (6.5)

3.4–11.2

29 (10.1)

1.9–28.1

36 (7.8)

0.0–100.0

85 (8.1)

3.3–15.8
 Headache (10019211)

18 (5.9)

1.6–14.5

25 (8.7)

1.8–23.3

34 (7.4)

0.0–100.0

77 (7.3)

3.1–14.2
 Dizziness (10013573)

4 (1.3)

0.2–4.6

11 (3.8)

1.5–8.0

5 (1.1)

0.0–78.8

20 (1.9)

0.7–4.2
 Clumsiness (10009696); Dysgeusia (10013911); Paraesthesia (10033775); Tremor (10044565)

n: 0; 1; 0;

0 NR

n: 0; 0; 1;

1 NR

n: 1; 0; 0;

0 NR

1 (0.1)

each NR
Musculoskeletal and connective tissue disorders (10028395)

15 (4.9)

0.5–17.8

22 (7.6)

1.1–23.7

24 (5.2)

0.0–100.0

61 (5.8)

2.2–12.0
 Myalgia (10028411)

12 (3.9)

0.1–20.5

17 (5.9)

0.7–20.1

21 (4.6)

0.0–99.7

50 (4.7)

1.8–9.8
 Arthralgia (10003239)

4 (1.3)

0.3–3.5

10 (3.5)

0.0–24.1

9 (2.0)

0.0–92.4

23 (2.2)

0.7–5.1
 Pain in extremity (10033425)

1 (0.3)

0.0–6.7

0 (0.0)

0.0–1.3

2 (0.4)

0.0–8.6

3 (0.3)

0.1–0.8
 Limb discomfort (10061224)

1 (0.3)

0.0–3.6

0 (0.0)

0.0–1.3

1 (0.2)

0.0–45.9

2 (0.2)

0.0–0.8
 Muscle fatigue (10049565)

0 (0.0)

0.0–1.2

1 (0.4)

0.0–7.1

0 (0.0)

0.0–0.8

1 (0.1)

0.0–0.8
Gastrointestinal disorders (10017947)

15 (4.9)

1.6–11.0

18 (6.3)

0.8–20.8

24 (5.2)

0.0–44.6

57 (5.4)

3.9–7.3
 Diarrhoea (10012735)

6 (2.0)

0.5–5.2

12 (4.2)

0.4–15.2

13 (2.8)

0.0–45.0

31 (2.9)

1.7–4.6
 Nausea (10028813)

8 (2.6)

0.2–11.0

8 (2.8)

0.3–9.9

11 (2.4)

0.0–26.0

27 (2.6)

1.7–3.7
 Vomiting (10047700)

0 (0.0)

0.0–1.2

5 (1.7)

0.0–10.6

10 (2.2)

0.0–23.2

15 (1.4)

0.5–3.3
 Dry mouth (10013781)

2 (0.7)

0.0–7.1

0 (0)

0.0–1.3

0 (0)

0.0–0.8

2 (0.2)

0.0–1.4
 Lip swelling (10024570); Swollen tongue (10042727); Abdominal pain (10000081) Dysphagia (10013950); Paraesthesia oral (10057372)

n: 1;0;1;0;

0 NR

n: 0;1;0;1;

1 NR

n: 0;0;0;0;

0 NR

1 (0.1)

each NR
Respiratory, thoracic and mediastinal disorders (10038738)

11 (3.6)

0.8–9.8

19 (6.6)

0.0–40.1

14 (3.0)

1.1–6.5

44 (4.2)

2.0–7.6
 Rhinorrhoea (10039101)

10 (3.3)

0.9–8.0

17 (5.9)

0.1–32.5

10 (2.2)

0.0–37.1

37 (3.5)

1.5–6.9
 Cough (10011224)

0 (0.0)

0.0–1.2

1 (0.4)

0.0–7.1

5 (1.1)

0.0–12.2

6 (0.6)

0.1–1.7
 Nasal congestion (10028735)

0 (0.0)

0.0–1.2

0 (0.0)

0.0–1.3

4 (0.9)

0.0–4.7

4 (0.4)

0.1–1.3
 Oropharyngeal pain (10068319)

2 (0.7)

0.0–7.1

1 (0.4)

0.0–7.1

0 (0.0)

0.0–0.8

3 (0.3)

0.0–1.3
 Sneezing (10041232)

1 (0.3)

0.0–10.4

0 (0.0)

0.0–1.3

2 (0.4)

0.0–25.6

3 (0.3)

0.0–1.0
 Pharyngeal swelling (10082270); Aphonia (10002953)

n: 0;

1 NR

n: 0;

0 NR

n: 1;

0 NR

1 (0.1)

each NR
Skin and subcutaneous tissue disorders (10040785)

3 (1.0)

0.1–4.0

15 (5.2)

0.4–20.4

8 (1.7)

0.1–9.2

26 (2.5)

0.9–5.3
 Pruritus (10037087)

2 (0.7)

0.0–5.8

14 (4.9)

0.5–17.6

6 (1.3)

0.5–2.8

22 (2.1)

0.6–5.0
 Rash (10037844)

0 (0.0)

0.0–1.2

3 (1.0)

0.0–6.8

2 (0.4)

0.0–25.6

5 (0.5)

0.1–1.3
 Eczema (10014184); Hyperhidrosis (10020642)

n: 0;

1 NR

n: 0;

0 NR

n: 1;

0 NR

1 (0.1)

each NR
Metabolism and nutrition disorders (10027433)

3 (1.0)

0.1–4.0

3 (1.0)

0.1–4.1

12 (2.6)

1.4–4.5

18 (1.7)

0.9–2.9
 Decreased appetite (10061428)

2 (0.7)

0.1–2.3

3 (1.0)

0.1–4.1

12 (2.6)

1.4–4.5

17 (1.6)

0.8–2.9
Type 1 diabetes mellitus (10067584)

1 (0.3)

0.0–10.4

0 (0.0)

0.0–1.3

0 (0.0)

0.0–0.8

1 (0.1)

0.0–0.8
 Psychiatric disorders (10037175)

1(0.3)

0.0–6.7

5 (1.7)

0.1–8.7

6 (1.3)

0.0–20.9

12 (1.1)

0.5–2.2
 Irritability (10022998)

1(0.3)

0.0–6.7

5 (1.7)

0.1–8.7

6 (1.3)

0.0–20.9

12 (1.1)

0.5–2.2
Eye disorders (10015919)

7 (2.3)

0.3–8.2

2 (0.7)

0.0–13.7

1 (0.2)

0.0–45.9

10 (1.0)

0.2–2.8
 Eye allergy (10015907)

5 (1.6)

0.1–8.0

2 (0.7)

0.0–13.7

1 (0.2)

0.0–45.9

8 (0.8)

0.2–2.1
 Lacrimation increased (10023644); Visual impairment (10047571)

n: 1;

1 NR

n: 0;

0 NR

n: 0;

0 NR

1 (0.1)

each NR
Infections and infestations (10021881)

1 (0.3)

0.0–6.7

2 (0.7)

0.0–13.7

2 (0.4)

0.0–8.6

5 (0.5)

0.1–1.3
 Suspected COVID-19 (10084451)

1 (0.3)

0.0–6.7

0 (0.0)

0.0–1.3

1 (0.2)

0.0–13.7

2 (0.2)

0.0–0.7
 Herpes virus infection (10019973); Nasopharyngitis (10028810), Oral herpes (10067152)

n: 0; 0;

0 NR

n: 1; 0;

1 NR

n: 0; 1;

0 NR

1 (0.1)

each NR
Immune system disorders (10021428)

0 (0.0)

0.0–1.2

2 (0.7)

0.1–2.6

0 (0.0)

0.0–0.8

2 (0.2)

0.0–0.9

In italics: predefined adverse events of interest (AEIs) listed on the adverse drug reaction (ADR) card

AE adverse event, Any at least one symptom experienced (regardless of the MedDRA preferred term) under the specified system organ class, COVID-19 coronavirus disease 2019, MedDRA Medical Dictionary for Regulatory Activities, N total number of participants vaccinated with GSK’s inactivated quadrivalent seasonal influenza vaccine (IIV4) who received an ADR card, n (%) number (percentage) of participants vaccinated with GSK’s IIV4 reporting the symptom at least once on their ADR card, NR AEs that occurred in three or fewer cases were grouped to simplify the table, with the number of cases presented for each symptom and the total number (%) for each symptom, but not each individual 95% CI; 95% CI, LL-UL 95% confidence interval (extended Clopper–Pearson exact CI for clustered data), lower limit–upper limit