Table 5.
Benefits and harms of the HPV vaccines: summary of fatal and serious harms
| Summary of fatal and serious harmsa | HPV vaccine (N = 47,075) | Comparator (N = 48,595) | Risk ratioe [95% CI] |
|---|---|---|---|
| Fatal harms | |||
| Participants with fatal harmsb | 45 | 38 | 1.19 [0.65, 2.19] |
| Number of MedDRA-classified fatal harmsb | 79 | 51 | Not applicable |
| Number of fatal harms judged HPV vaccine-related | 0 (0%) | 0 (0%) | Not applicable |
| Most common fatal harms (MedDRA-preferred terms, n = participants) | |||
| Cardiorespiratory arrest | 3 | 2 | 0.99 [0.13, 7.65] |
| Completed suicide | 4 | 8 | 0.58 [0.15, 2.19] |
| Gunshot wound | 2 | 3 | 0.74 [0.09, 5.85] |
| Homicide | 2 | 2 | 0.95 [0.14, 6.50] |
| Road traffic accident | 5 | 7 | 0.77 [0.24, 2.46] |
| Fatal harms most increased by the HPV vaccines (MedDRA-preferred terms, n = participants) | |||
| Cardiac arrest | 2 | 0 | 3.00 [0.31, 28.82] |
| Metastases to lung | 2 | 0 | 3.00 [0.31, 28.82] |
| Renal failure acute | 2 | 0 | 3.00 [0.31, 28.82] |
| Systemic lupus erythematosus | 2 | 0 | 3.00 [0.31, 28.82] |
| Traumatic intracranial haemorrhage | 2 | 0 | 3.00 [0.31, 28.82] |
| Fatal harms most decreased by the HPV vaccines (MedDRA-preferred terms, n = participants)c | |||
| Completed suicide | 4 | 8 | 0.58 [0.15, 2.19] |
| Gunshot wound | 2 | 3 | 0.74 [0.09, 5.85] |
| Road traffic accident | 5 | 7 | 0.77 [0.24, 2.46] |
| Serious harms | |||
| Participants with serious harmsd | 1404 | 1357 | 1.01 [0.94, 1.08] |
| Participants that withdrew due to a serious harm | 54 (4%) | 49 (4%) | 1.08 [0.72, 1.61] |
| Number of MedDRA-classified serious harmsd | 1741 | 1628 | Not applicable |
| Number of serious harms judged HPV vaccine-related | 46 (3%) | 44 (3%) | Not applicable |
| Most common serious harms (MedDRA-preferred terms, n = participants) | |||
| Abortion missed | 33 | 41 | 0.81 [0.51, 1.27] |
| Abortion spontaneous | 89 | 78 | 1.14 [0.84, 1.55] |
| Abortion spontaneous complete | 63 | 62 | 1.01 [0.71, 1.44] |
| Abortion spontaneous incomplete | 73 | 54 | 1.35 [0.95, 1.92] |
| Appendicitis | 72 | 82 | 0.85 [0.62, 1.17] |
| Serious harms most increased by the HPV vaccines (MedDRA-preferred terms, n = participants) | |||
| Abortion spontaneous | 89 | 78 | 1.14 [0.84, 1.55] |
| Abortion spontaneous incomplete | 73 | 54 | 1.35 [0.95, 1.92] |
| Pneumonia | 26 | 15 | 1.64 [0.87, 3.09] |
| Pyelonephritis | 31 | 17 | 1.70 [0.93, 3.10] |
| Tonsillitis | 18 | 9 | 1.59 [0.72, 3.49] |
| Serious harms most decreased by the HPV vaccines (MedDRA-preferred terms, n = participants) | |||
| Abortion missed | 33 | 41 | 0.81 [0.51, 1.27] |
| Appendicitis | 72 | 82 | 0.85 [0.62, 1.17] |
| Ligament rupture | 5 | 12 | 0.44 [0.15, 1.29] |
| Ovarian cyst rupture | 6 | 13 | 0.46 [0.18, 1.21] |
| Overdose | 22 | 31 | 0.72 [0.42, 1.23] |
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
bThe clinical study reports reported 130 individual MedDRA-classified fatal harms for 83 participants
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
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
eRisk ratios were calculated with the random-effects inverse variance method