Trends of Adverse Events Following Immunization (AEFI) Reports of Human Papillomavirus Vaccine in the Valencian Community—Spain (2008–2018)
Abstract
:1. Introduction
2. Materials and Methods
2.1. Data Source
2.2. Data Extraction
2.3. Descriptive Analysis
2.4. Trend Analysis
2.5. Ethical Statement
3. Results
3.1. Trends over Time by Setting
3.2. Trend in AEFI Notifications by Age According to the Joinpoints Identified by the Analysis
3.3. The Trend of AEFIs Reported as ‘Serious’
3.4. Events Following Immunization Reactions
4. Discussion
5. Conclusions
Author Contributions
Funding
Conflicts of Interest
Appendix A
Years | 11 to 13 Years Old | 14 to 15 Years Old | >15 Years Old * | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
ICSR | Doses | AEFI Rate | 95%CI | ICSR | Doses | AEFI Rate | 95%CI | ICSR | Doses | AEFI Rate | 95%CI | |
2008 | 2 | 2424 | 82.51 | 9.99–298.05 | 32 | 18,875 | 169.54 | 110.8–228.28 | 7 | 8813 | 79.43 | 31.93–163.65 |
2009 | 0 | 1003 | 0 | 0.00–367.78 | 105 | 48,220 | 217.75 | 176.10–259.4 | 5 | 8010 | 62.42 | 20.27–145.67 |
2010 | 2 | 3217 | 62.17 | 7.53–224.58 | 41 | 51,121 | 80.2 | 55.65–104.75 | 0 | 3863 | 0 | 0.00–95.49 |
2011 | 0 | 9130 | 0 | 0.00–40.40 | 16 | 54,350 | 29.44 | 15.01–43.86 | 1 | 4609 | 21.7 | 0.55–120.89 |
2012 | 7 | 11,494 | 60.9 | 24.49–125.48 | 20 | 46,171 | 43.32 | 24.33–62.30 | 0 | 4592 | 0 | 0.00–80.33 |
2013 | 6 | 13,418 | 44.72 | 16.41–97.33 | 15 | 45,625 | 32.88 | 16.24–49.51 | 3 | 5083 | 59.02 | 12.17–172.48 |
2014 | 2 | 10,083 | 19.84 | 2.40–71.65 | 13 | 33,958 | 38.28 | 17.47–59.09 | 1 | 4978 | 20.09 | 0.51–111.93 |
2015 | 8 | 34,885 | 22.93 | 9.90–45.19 | 4 | 29,914 | 13.37 | 0.27–26.48 | 1 | 5381 | 18.58 | 0.47–103.54 |
2016 | 5 | 56,405 | 8.86 | 2.88–20.69 | 1 | 17,283 | 5.79 | 0.00–17.13 | 1 | 5073 | 19.71 | 0.50–109.83 |
2017 | 4 | 47,565 | 8.41 | 2.29–21.53 | 1 | 10,241 | 9.76 | 0.00–28.90 | 1 | 5596 | 17.87 | 0.45–99.56 |
2018 | 10 | 46,685 | 21.42 | 10.27–39.39 | 2 | 8475 | 23.6 | 0.00–56.31 | 0 | 8182 | 0 | 0.00–45.09 |
Total | 46 | 236,309 | 19.47 | 13.84–25.09 | 250 | 364,233 | 68.64 | 60.13–77.15 | 20 | 64,180 | 31.16 | 17.50–44.82 |
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Years | AEFIr | Doses | AEFIr Rate 1 | 95%CI | Total AE | AEFIr with Serious AE | Total Serious AE | Total AE/AEFIr | Total AE Serious/AEFIr | AEFIr Serious Rate 1 |
---|---|---|---|---|---|---|---|---|---|---|
2008 | 41 | 30,112 | 136.16 | 94.48–177.84 | 154 | 18 | 110 | 3.76 | 2.68 | 59.78 |
2009 | 110 | 57,233 | 192.2 | 156.28–228.11 | 296 | 24 | 134 | 2.69 | 1.22 | 41.93 |
2010 | 43 | 58,201 | 73.88 | 51.80–95.96 | 93 | 13 | 29 | 2.16 | 0.67 | 22.34 |
2011 | 17 | 68,089 | 24.97 | 13.10–36.84 | 36 | 6 | 22 | 2.12 | 1.29 | 8.81 |
2012 | 27 | 62,257 | 43.37 | 27.01–59.73 | 57 | 3 | 7 | 2.11 | 0.26 | 4.82 |
2013 | 24 | 64,126 | 37.43 | 22.45–52.40 | 56 | 8 | 24 | 2.33 | 1.00 | 12.48 |
2014 | 16 | 49,019 | 32.64 | 16.65–48.63 | 34 | 2 | 10 | 2.13 | 0.63 | 4.08 |
2015 | 13 | 70,180 | 18.52 | 8.45–28.59 | 34 | 6 | 21 | 2.62 | 1.62 | 8.55 |
2016 | 7 | 78,761 | 11.04 | 2.30–15.47 | 15 | 1 | 1 | 1.43 | 0.43 | 1.27 |
2017 | 7 | 63,402 | 9.46 | 1.89–17.04 | 10 | 1 | 3 | 1.67 | 0.50 | 1.58 |
2018 | 12 | 63,342 | 18.94 | 8.23–29.66 | 27 | 1 | 1 | 2.25 | 0.08 | 1.58 |
Total | 317 | 66,4722 | 47.54 | 42.30–52.78 | 812 | 83 | 362 | 2.57 | 1.14 | 12.49 |
2008 | 2009 | 2010 | 2011 | 2012 | 2013 | 2014 | 2015 | 2016 | 2017 | 2018 | |
---|---|---|---|---|---|---|---|---|---|---|---|
AEFI a | (n) | (n) | (n) | (n) | (n) | (n) | (n) | (n) | (n) | (n) | (n) |
Injection site reaction b | 8 | 24 | 11 | 6 | 9 | 4 | 2 | 1 | 6 | 3 | 8 |
Headache | 7 | 33 | 6 | 4 | 7 | 11 | 3 | 5 | 2 | 0 | 1 |
Dizziness | 12 | 32 | 7 | 2 | 0 | 3 | 6 | 4 | 1 | 1 | 4 |
Fever | 2 | 26 | 12 | 6 | 7 | 9 | 2 | 3 | 1 | 2 | 0 |
Syncope | 11 | 21 | 12 | 3 | 5 | 2 | 3 | 3 | 1 | 0 | 1 |
Myalgia and malaise | 1 | 16 | 6 | 2 | 4 | 3 | 1 | 6 | 1 | 2 | 1 |
Nausea/ vomiting | 4 | 20 | 4 | 1 | 3 | 4 | 3 | 1 | 0 | 0 | 1 |
Presyncope/Pallor | 6 | 11 | 2 | 1 | 2 | 0 | 3 | 1 | 1 | 1 | 5 |
Hypersensitivity reaction c | 3 | 11 | 5 | 0 | 6 | 1 | 2 | 1 | 0 | 1 | 1 |
Seizure | 0 | 9 | 3 | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 0 |
Somnolence | 3 | 4 | 2 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 1 |
Others | 97 | 89 | 23 | 10 | 12 | 17 | 9 | 8 | 2 | 0 | 4 |
Total | 154 | 296 | 93 | 36 | 57 | 56 | 34 | 34 | 15 | 10 | 27 |
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Egoavil, C.M.; Tuells, J.; Carreras, J.J.; Montagud, E.; Pastor-Villalba, E.; Caballero, P.; Nolasco, A. Trends of Adverse Events Following Immunization (AEFI) Reports of Human Papillomavirus Vaccine in the Valencian Community—Spain (2008–2018). Vaccines 2020, 8, 117. https://doi.org/10.3390/vaccines8010117
Egoavil CM, Tuells J, Carreras JJ, Montagud E, Pastor-Villalba E, Caballero P, Nolasco A. Trends of Adverse Events Following Immunization (AEFI) Reports of Human Papillomavirus Vaccine in the Valencian Community—Spain (2008–2018). Vaccines. 2020; 8(1):117. https://doi.org/10.3390/vaccines8010117
Chicago/Turabian StyleEgoavil, Cecilia M., José Tuells, Juan José Carreras, Emilia Montagud, Eliseo Pastor-Villalba, Pablo Caballero, and Andreu Nolasco. 2020. "Trends of Adverse Events Following Immunization (AEFI) Reports of Human Papillomavirus Vaccine in the Valencian Community—Spain (2008–2018)" Vaccines 8, no. 1: 117. https://doi.org/10.3390/vaccines8010117