Skip to main content

Table 5 Benefits and harms of the HPV vaccines: summary of fatal and serious harms

From: Benefits and harms of the human papillomavirus (HPV) vaccines: systematic review with meta-analyses of trial data from clinical study reports

Summary of fatal and serious harmsaHPV vaccine (N = 47,075)Comparator (N = 48,595)Risk ratioe [95% CI]
Fatal harms
 Participants with fatal harmsb45381.19 [0.65, 2.19]
 Number of MedDRA-classified fatal harmsb7951Not applicable
  Number of fatal harms judged HPV vaccine-related0 (0%)0 (0%)Not applicable
Most common fatal harms (MedDRA-preferred terms, n = participants)
 Cardiorespiratory arrest320.99 [0.13, 7.65]
 Completed suicide480.58 [0.15, 2.19]
 Gunshot wound230.74 [0.09, 5.85]
 Homicide220.95 [0.14, 6.50]
 Road traffic accident570.77 [0.24, 2.46]
Fatal harms most increased by the HPV vaccines (MedDRA-preferred terms, n = participants)
 Cardiac arrest203.00 [0.31, 28.82]
 Metastases to lung203.00 [0.31, 28.82]
 Renal failure acute203.00 [0.31, 28.82]
 Systemic lupus erythematosus203.00 [0.31, 28.82]
 Traumatic intracranial haemorrhage203.00 [0.31, 28.82]
Fatal harms most decreased by the HPV vaccines (MedDRA-preferred terms, n = participants)c
 Completed suicide480.58 [0.15, 2.19]
 Gunshot wound230.74 [0.09, 5.85]
 Road traffic accident570.77 [0.24, 2.46]
Serious harms
 Participants with serious harmsd140413571.01 [0.94, 1.08]
  Participants that withdrew due to a serious harm54 (4%)49 (4%)1.08 [0.72, 1.61]
 Number of MedDRA-classified serious harmsd17411628Not applicable
  Number of serious harms judged HPV vaccine-related46 (3%)44 (3%)Not applicable
Most common serious harms (MedDRA-preferred terms, n = participants)
 Abortion missed33410.81 [0.51, 1.27]
 Abortion spontaneous89781.14 [0.84, 1.55]
 Abortion spontaneous complete63621.01 [0.71, 1.44]
 Abortion spontaneous incomplete73541.35 [0.95, 1.92]
 Appendicitis72820.85 [0.62, 1.17]
Serious harms most increased by the HPV vaccines (MedDRA-preferred terms, n = participants)
 Abortion spontaneous89781.14 [0.84, 1.55]
 Abortion spontaneous incomplete73541.35 [0.95, 1.92]
 Pneumonia26151.64 [0.87, 3.09]
 Pyelonephritis31171.70 [0.93, 3.10]
 Tonsillitis1891.59 [0.72, 3.49]
Serious harms most decreased by the HPV vaccines (MedDRA-preferred terms, n = participants)
 Abortion missed33410.81 [0.51, 1.27]
 Appendicitis72820.85 [0.62, 1.17]
 Ligament rupture5120.44 [0.15, 1.29]
 Ovarian cyst rupture6130.46 [0.18, 1.21]
 Overdose22310.72 [0.42, 1.23]
  1. aSee Additional file 4 sections 9 and 10 for fatal and serious harm meta-analyses. The applied harm categories are MedDRA-preferred terms. It was not feasible to present this summary table for the 16 subgroups (based on age group, gender, type of HPV vaccine and comparator) of the 24 included clinical study reports
  2. bThe clinical study reports reported 130 individual MedDRA-classified fatal harms for 83 participants
  3. cThere were 20 different MedDRA-preferred term categories of fatal harms with the same non-significant difference, i.e. no fatal harm in the HPV vaccine group and one fatal harm in the comparator group
  4. dThe clinical study reports reported 3369 individual MedDRA-classified serious harms for 2761 participants, i.e. 1.2 serious harms per participant. Each MedDRA-classified serious harm was reported as the number of participants with a MedDRA-classified serious harm over the total number of participants
  5. eRisk ratios were calculated with the random-effects inverse variance method