Table 3 Disproportionality analysis at the preferred term level

General disorders and administration site conditions

PYREXIA

118

6.61(5.46–80)

2.56(2.24–2.78)

ILLNESS

78

23.41(18.6–29.47)

4.27(3.65–4.48)

INFLUENZA LIKE ILLNESS

76

16.83(13.33–21.24)

3.85(3.30–4.08)

CHILLS

62

9.87(7.64–12.75)

3.14(2.61–3.41)

INJECTION SITE PAIN

39

2.57(1.87–3.54)

1.31(0.75–1.68)

NECROSIS

19

60.28(38.27–94.94)

4.57(1.14–4.44)

OEDEMA

18

6.12(3.84–9.76)

2.41(1.33–2.89)

INJECTION SITE ERYTHEMA

18

2.66(1.67–4.24)

1.34(0.47–1.87)

INFLAMMATION

14

2.31(1.36–3.91)

1.13(0.15–1.73)

INJECTION SITE HAEMORRHAGE

13

3.10(1.79–5.36)

1.51(0.42–2.12)

INJECTION SITE PRURITUS

10

2.76(1.48–5.14)

1.34(0.08–2.02)

Infections and infestations

INFLUENZA

78

7.70(6.12–9.69)

2.80(2.37–3.06)

ORAL HERPES

42

42.82(31.45–58.29)

4.80(3.23–4.91)

HERPES SIMPLEX

34

70.57(50.12–99.34)

5.11(2.54–5.02)

HERPES VIRUS INFECTION

30

97.28(67.61–139.96)

5.22(1.92–4.98)

CELLULITIS

22

6.86(4.50–10.46)

2.58(1.61–3.02)

SEPSIS

21

2.42(1.57–3.72)

1.21(0.43–1.71)

ENCEPHALITIS

9

11.8(6.12–22.75)

2.90(0.43–3.33)

Skin and subcutaneous tissue disorders

DERMATITIS

12

2.31(1.31–4.07)

1.12(0.05–1.77)

SKIN LESION

10

6.36(3.41–11.85)

2.33(0.65–2.91)

Nervous system disorders

SYNCOPE

27

3.89(2.65–5.69)

1.86(1.14–2.29)

Blood and lymphatic system disorders

LYMPHADENOPATHY

9

4.09(2.12–7.88)

1.81(0.29–2.47)