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Table. 2.

Table. 2.

Summary of the vaccine safety researches exploring the causal relationship between the vaccine and adverse event of interest published in the past 4 years from 2015 to 2018

PopulationPeriodTarget vaccine(s)Adverse event(s) (n=study participants)Primary outcome
General population2008~2012Influenza vaccineNarcolepsy (n=1,638,526)HR = 17.21 (95% CI: 6.28-47.14)
2007~2014Respiratory diseases (n=387,633)OR = 0.97 (95% CI: 0.82-1.15)
2009~2013Facial nerve paralysis (n=6,000,000)RI = 0.85 (95% CI: 0.72-1.01)
2013~2014Hypersensitivity (n=62,040)HR = 0.25 (95% CI: 0.04-0.96)
2007~2012VTE (n=497)HR = 0.89 (95% CI: 0.69-1.17)
2014PCV/PPSVDermal necrotizing Granulomatous giant cell reactionLimited to single case report
2004~2008Cardiovascular events (n=1,074)Effects of reduced hospital days compared to influenza vaccine.
2008~2012Osteitis, osteomyelitis (n=38)10-fold increase in the incidence from 2002-2006 to 2008-2012
unknownBCG vaccineLymphadenitis (n=4,262)5-fold increase in the reporting rate from the package insert
1989~2004Infectious disease (n=19,363)Lower risk of tuberculosis
1974~1994Asthma (n=35,612)OR = 0.95 (95% CI: 0.87-1.04)
2007~2016HPV vaccineGBS (n=101)RI = 1.04 (95% CI: 0.47-2.28)
2006~2014Ovarian cancer, IBS (n=48,852)OR = 10.021 (95 % CI 3.725-33.749)
2018Myasthenia gravisLimited to single case report
2012~2015Rota virus vaccineDiarrhoea-associated mortality (n=48,672)Relative risk decreased (31%)
2008~2014Intussusception (n=1,103)DRR = 7.5 (95% CI: 2.3-24.6)
2018Optic neuritisLimited to single case report
1999~2010DTaP vaccineMortality (n=3,382,978)Declined with increasing age from 127.4, 90.5, to 59.3 deaths per 100,000 person-years
2008~2010Hospitalization, overall AEs (n=14,042)No relations
2009~2015MMR vaccineImmune thrombocytopenia (n=2,549)OR = 1.60 (95% CI: 1.09-2.34)
1999~2013Henoch-Schönlein purpura (n=89)OR = 3.4 (95% CI: 1.2-10.0)
1997~2006Lower respiratory infection (n=4,965)IRR = 1.27 (95% CI: 1.13-1.42)
2006~2013VAR vaccineStroke (n=325,729)aHR = 1.6 (95% CI 0.7-3.7)

Pregnant Women2010~2015Influenza vaccineAdverse birth outcome (n=64,768)All 95% CI of aHRs contained 1
2000~2010Autism (n=196,929)aHR = 1.10 (95% CI, 1.00-1.21)
2010~2014Fetus harm (n=1,730)All 95% CI of aHRs contained 1
2007~2013HPV vaccineAdverse birth outcome (n=64,748)All 95% CI of RRs contained 1
2004~2014Tdap vaccineFetus harm, hospitalization, death, overall AEs (n= 9,554)All 95% CI of aORs contained 1
2017Optic neuritis (n=2)Limited to single case report

Patients with auto-immune diseases2005~2007Influenza vaccineDisease activity, immune response (n=28)No difference between patients and controls
2013Septic shock, multi-organ dysfunction (n=2)Limited to single case report
2002PCV/PPSVImmune response, disease activity (n=86)No statistical difference
UnknownHPV vaccineSLE flare (n=34)No relation between AE and vaccine

VTE, venous thromboembolism; PCV, pneumococcal conjugate vaccine; PPSV, pneumococcal polysaccharide vaccine; BCG, Bacillus Calmette-Guérin; HPV, human papillomavirus; GBS, Guillain-Barre syndrome; IBS, Irritable Bowel Syndrome; DTaP, Diphtheria, Tetanus and acel- lular Pertussis; AE, Adverse Event; MMR, Measles, Mumps, and Rubella; VAR, Varicella; Tdap, Tetanus, reduced diphtheria and acellular pertussis; SLE; Systemic Lupus Erythematosus; HR, Hazard Ratio; aHRs, adjusted Hazard Ratio; OR, Odds Ratio; aOR, adjusted Odds Ratio; RI, Relative Incidence; CI, Confidence Interval; DRR, Daily Reporting Ratio; IRR, Incidence Rate Ratio; RR, Relative Risk

Korean J Clin Pharm 2019;29:173-85 https://doi.org/10.24304/kjcp.2019.29.3.173
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