Summary of general harmsa | HPV vaccine total (N = 47,075) | Comparator total (N = 48,595) | Risk ratiof total [95% CI] | Risk ratiof SGAE [95% CI] | Risk ratiof UGAE [95% CI] | Risk ratiof SYAE [95% CI] |
---|---|---|---|---|---|---|
Total | ||||||
Participants with general harmsb | 13,248 | 12,394 | 1.07 [1.03, 1.11] | 1.11 [1.06, 1.16]g | 1.11 [1.06, 1.16]g | 1.01 [0.98, 1.03] |
Number of MedDRA-classified general harmsb | 37,999 | 31,916 | Not applicable | Not applicable | Not applicable | Not applicable |
Solicited general adverse events (SGAE)c | 30,408 (80%) | 25,300 (79%) | Not applicable | Not applicable | Not applicable | Not applicable |
Unsolicited general adverse events (UGAE)d | 3197 (8%) | 3136 (10%) | Not applicable | Not applicable | Not applicable | Not applicable |
Systemic adverse events (SYAE)e | 4394 (12%) | 3480 (11%) | Not applicable | Not applicable | Not applicable | Not applicable |
Most common general harms (MedDRA-preferred terms, n = participants) | ||||||
SGAE and UGAE | ||||||
Fatigue | 4933 | 4489 | 1.13 [1.08, 1.18] | 1.14 [1.09, 1.19] | 1.00 [0.15, 6.53] | 0.92 [0.70, 1.20] |
Headache | 5561 | 5246 | 1.06 [1.02, 1.11] | 1.08 [1.03, 1.14] | 1.76 [1.26, 2.47] | 0.98 [0.90, 1.07] |
Myalgia | 3989 | 3047 | 1.41 [1.24, 1.60] | 1.42 [1.24, 1.63] | 1.15 [0.24, 5.57] | 1.33 [0.95, 1.85] |
SYAE | ||||||
Headache | 5561 | 5246 | 1.06 [1.02, 1.11] | 1.08 [1.03, 1.14] | 1.76 [1.26, 2.47] | 0.98 [0.90, 1.07] |
Pyrexia | 1599 | 1386 | 1.12 [1.02, 1.22] | 1.15 [1.06, 1.25] | 1.47 [0.93, 2.34] | 1.05 [0.80, 1.36] |
Nasopharyngitis | 339 | 277 | 1.17 [0.91, 1.50] | Not applicable | 1.40 [0.94, 2.09] | 0.95 [0.78, 1.16] |
General harms most increased by the HPV vaccines (MedDRA-preferred terms, n = participants) | ||||||
SGAE and UGAE | ||||||
Fatigue | 4933 | 4489 | 1.13 [1.08, 1.18] | 1.14 [1.09, 1.19] | 1.00 [0.15, 6.53] | 0.92 [0.70, 1.20] |
Headache | 5561 | 5246 | 1.06 [1.02, 1.11] | 1.08 [1.03, 1.14] | 1.76 [1.26, 2.47] | 0.98 [0.90, 1.07] |
Myalgia | 3989 | 3047 | 1.41 [1.24, 1.60] | 1.42 [1.24, 1.63] | 1.15 [0.24, 5.57] | 1.33 [0.95, 1.85] |
SYAE | ||||||
Myalgia | 3989 | 3047 | 1.41 [1.24, 1.60] | 1.42 [1.24, 1.63] | 1.15 [0.24, 5.57] | 1.33 [0.95, 1.85] |
Nausea | 213 | 148 | 1.21 [0.89, 1.65] | Not applicable | 1.32 [0.35, 4.98] | 1.25 [0.84, 1.86] |
Pyrexia | 1599 | 1386 | 1.12 [1.02, 1.22] | 1.15 [1.06, 1.25] | 1.47 [0.93, 2.34] | 1.05 [0.80, 1.36] |
General harms most decreased by the HPV vaccines (MedDRA-preferred terms, n = participants) | ||||||
SGAE and UGAE | ||||||
Influenza | 119 | 120 | 0.91 [0.61, 1.36] | Not applicable | 0.88 [0.39, 1.97] | 0.94 [0.56, 1.58] |
Cough | 86 | 87 | 0.89 [0.65, 1.21] | Not applicable | 0.83 [0.46, 1.49] | 0.90 [0.60, 1.37] |
Oropharyngeal pain | 111 | 97 | 1.10 [0.80, 1.50] | Not applicable | 0.91 [0.58, 1.43] | 1.29 [0.75, 2.22] |
SYAE | ||||||
Fungal infection | 4 | 11 | 0.78 [0.09, 6.43] | Not applicable | 3.01 [0.31, 28.83] | 0.18 [0.04, 0.82] |
Sinus headache | 9 | 15 | 0.49 [0.21, 1.14] | Not applicable | Not applicable | 0.49 [0.21, 1.14] |
Joint injury | 2 | 5 | 0.47 [0.11, 2.01] | Not applicable | 3.01 [0.31, 28.83] | 0.15 [0.03, 0.88] |