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Table. 3.

Table. 3.

Frequency and reporting odds ratios of adverse event reports in HPV vaccine compared with all other vaccines: according to applicability of the Brighton Collaboration criteria

Adverse events following immunization HPV vaccines (n=2,845) all other vaccines (n=20,278) ROR (95% CI) Drug label
(A) Adverse events included in Brighton Collaboration criteria
1 A local reaction at or near injection site 1,113 7,772 1.03 (0.95-1.12) Y
2 Immunization site pain 896 5,281 1.31 (1.20-1.42)† Y
3 Fever 229 2,509 0.62 (0.54-0.71)† Y
4 Guillain-Barre syndrome (SMQ)* 192 924 1.52 (1.29-1.78)† Y
5 Swelling at or near injection site 130 1,182 0.77 (0.64-0.93)† Y
6 Fatigue 49 1,199 0.28 (0.21-0.37)† Y
7 Diarrhea 32 508 0.44 (0.31-0.63)† Y
8 Induration at or near injection site 24 301 0.57 (0.37-0.86)† Y
9 Anaphylactic reaction (SMQ)* 20 159 0.90 (0.56-1.43) Y
10 Encephalitis, myelitis, and acute disseminated encephalomyelitis 11 27 2.91 (1.44-5.88)† Y
11 Generalised convulsive seizures following immunisation (SMQ)* 11 89 0.88 (0.47-1.65) Y
12 Spontaneous abortion and ectopic pregnancy 8 4 14.29 (4.30-47.49)† Y
13 Vasculitic peripheral neuropathy 6 5 8.57 (2.61-28.10)† N
14 Acute aseptic arthritis 6 14 3.06 (1.18-7.97)† Y
15 Facial nerve palsy including Bell’s palsy: 6 39 1.10 (0.46-2.59) Y
16 Nodule at injection site 4 8 3.57 (1.07-11.86)† Y
17 Systemic lupus erythematosus (SMQ)* 4 11 2.59 (0.83-8.15) N
18 Eczema vaccinatum 3 32 0.67 (0.20-2.18) Y
19 Abscess at injection site 2 55 0.26 (0.06-1.06) Y
20 Narcolepsy 1 10 0.71 (0.09-5.57) Y
21 Thrombocytopenia 1 20 0.36 (0.05-2.66) Y

(B) Adverse events NOT included in Brighton Collaboration criteria
1 Dizziness 195 586 2.47 (2.09-2.92)† Y
2 Inappropriate schedule of drug administration 161 53 22.89 (16.74-31.30)† N
3 Myalgia 142 2523 0.37 (0.31-0.44)† Y
4 Headache 135 1,376 0.68 (0.57-0.82)† Y
5 Nausea 114 638 1.29 (1.05-1.58)† Y
6 Drug exposure in pregnancy 110 34 23.95 (16.27-35.25)† N
7 Pharyngitis 101 1,207 0.58 (0.47-0.72)† Y
8 Vomiting 94 660 1.02 (0.82-1.27) Y
9 Pain 81 623 0.93 (0.73-1.17) Y
10 Medication error 75 99 5.52 (4.08-7.47)† N
11 Leg pain 75 119 4.59 (3.43-6.14)† Y
12 Arthralgia 57 271 1.51 (1.13-2.01)† Y
13 Infection viral 47 48 7.08 (4.73-10.61)† Y
14 Abdominal pain 45 204 1.58 (1.14-2.19)† Y
15 Dysmenorrhoea 39 13 21.67 (11.55-40.64)† Y
16 Tremor 38 51 5.37 (3.52-8.19)† Y

* Defined by broad search of standardised MedDRA queries (SMQ)

† Statistically significant

Korean J Clin Pharm 2020;30:19-30 https://doi.org/10.24304/kjcp.2020.30.1.19
© 2020 Korean J Clin Pharm