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

Jørgensen, Lars; Gøtzsche, Peter C.; Jefferson, Tom

doi:10.1186/s13643-019-0983-y

Systematic Reviews

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 harms^a	HPV vaccine (N = 47,075)	Comparator (N = 48,595)	Risk ratio^e [95% CI]
Fatal harms
Participants with fatal harms^b	45	38	1.19 [0.65, 2.19]
Number of MedDRA-classified fatal harms^b	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 harms^d	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 harms^d	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

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ISSN: 2046-4053

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