Adverse events following immunization (AEFI) reports of extended program immunization (EPI) in Indonesia during 1998-2002
Keywords:
immunization, adverse events following immunization, extended program of immunization, vaccine reaction
Abstract
Background The incidence of adverse events following immuni-zation (AEFI) increased in correlation with the number of vaccine
doses. Meanwhile AEFI reports should be managed properly to
maintain the compliance and immunization coverage.
Objectives The aims of this study were to investigate the inci-
dence and profile of AEFI, its onset, severity, classification, and
outcome.
Methods This study was a passive surveillance of AEFI reports
received by the National Committee on AEFI, Ministry of Health of
Indonesia, during 1998 to 2002.
Results Two hundreds and four AEFI cases were reported; 4 cases
as zero reports, 182 cases as individual reports, and 18 cluster
reports. The AEFI incidence was 0.44 per 1 million doses of vac-
cines. Vaccine reaction rate was 1 per 2.3 million vaccine doses.
The most common vaccines reported as the causes of AEFI were
DTP, Polio, and TT. Among 182 reported cases, local or mild AEFI
reactions were observed in 45, moderate in 49, and severe in 88.
Based on WHO field classification, this study reported that 84 cases
belonged to coincidence, 72 to vaccine reactions, 13 to program-
matic errors, 7 to injection reactions, and 6 to unclassified reac-
tions. Forty-seven patients died, 12 had some sequelae, and 123
completely recovered. Meanwhile, among the death cases, 70%
occurred coincidently, 17% due to vaccine reactions, and 6 were
unclassified.
Conclusions The incidence of AEFI in the extended program im-
munization (EPI) in Indonesia during the period of 1998-2002 were
182 cases, thus vaccine reaction rate was 1 per 2.3 million vac-
cine doses. The most common vaccine which caused AEFI was
DTP. Most AEFI with severe symptoms happened in 4-24 hours
after immunization.
References
1. World Health Organization. The world report 1998.
Geneva: WHO; 1998. p. 62.
2. The National Vaccine Advisory Committee. Strate-
gies to sustain success in childhood immunizations.
JAMA 1999; 282:363-9.
3. National Health and Medical Research Council. The
Australian immunisation handbook. 6th ed. Canberra:
NHMRC; 1997. p. 1-17.
4. Hadinegoro SR. Imunisasi pada anak: state of the art.
Presented at Kongres PETRI V; 1999 Nov 19-21;
Makassar.
5. Ward BJ. Vaccine adverse events in the new millen-
nium: is there reason for concern? Bull World Health
Organ 2000;78:205-15.
6. Chen RT. Safety of vaccines. In: Plotkin SA, Orenstein
WA, editors. Vaccines. 3rd ed. Philadelphia: WB
Saunders; 1999. p. 1144-63.
7. Stratton KR, Howe CJ, Johnston RB. Adverse events
associated with childhood vaccines. Washington DC:
Institute of Medicine; 1994. p. 1-55.
8. Loupi E, Baudard S, Debois H, Pignato F. Risk associ-
ated with vaccinations. Ann Med Interne
1998;149:361-71.
9. Mehta U, Milstien JB, Duclos P, Folb PI. Developing a
national system for dealing with adverse events fol-
lowing immunization. Bull World Health Organ
2000;78:170-7.
10. Atkinson W, Wolfe C, Humiston S, Nelson R. Epide-
miology and prevention of vaccine-preventable dis-
eases. 6th ed. Georgia: Public Health Foundation;
2000. p. 144-63.
11. World Health Organization. Immunization safety sur-
veillance. Geneva: WHO; 1999. p. 9-38.
12. Hadinegoro SR. Kejadian ikutan pasca imunisasi. Sari
Pediatri 2000;2:2-10.
13. Komite Nasional Pengkajian & Penanggulangan
Kejadian Ikutan Pasca Imunisasi (KN-PP KIPI).
Pedoman tatalaksana medik kejadian ikutan pasca
imunisasi (KIPI) bagi petugas kesehatan. 4th ed.
Jakarta: Direktorat Jenderal PPM-PL Departemen
Kesehatan RI; 2002.
14. Chen RT, Glasser JW, Rhodes PH. Vaccine safety datalink
project: a new tool for improving vaccine safety monitor-
ing in the United States. Pediatrics 1997;99:765-73.
15. Du Vernoy TS, Braun MM. Hypotonic-hyporesponsive
episodes reported to the Vaccine Adverse Event Report-
ing System (VAERS), 1996-1998. Pediatrics
2000;106:E52.
16. Singleton JA, Lloyd JC. Mootrey GT, Salive ME, Chen
RT. An overview of the vaccine adverse reporting sys-
tem (VAERS) as a surveillance system. Vaccine
1999;17:2908-17.
17. WHO. Supplementary information on vaccine safety
part 2: background rates of adverse events following
immunization. Geneva: WHO; 2000. p. 1-5.
18. Lawrence G, Menzies R, Burgess M, McIntyre P, Wood
N, Boyd I, et al. Surveillance of adverse events following
immunisation: Australia, 2000–2002. Commun Dis
Intell 2003;27:307–23.
19. Zhou W, Pool V, Iskander JK, English-Bullard R, Ball R,
Wise RP, et al. Surveillance for safety after immuniza-
tion: vaccine adverse event reporting system (VAERS)–
United States, 1991-2001. MMWR 2003;52:1-13.
20. WHO. Supplementary information on vaccine safety
part 1: field issues. Geneva: WHO; 2000. p. 3-9.
21. WHO. Global action plan for laboratory containment
of wild polioviruses. 2nd ed. Geneva: WHO; p. 4-6.
22. Kosen S. Study on safe injection practice in immuni-
zation campaign for schoolchildren (BIAS). A report
prepared for the Sub Directorate of Epidemiology and
Immunization, Directorate General of CDC and AHG,
MOH. Rep of Indonesia and the World Health Orga-
nization; 1999.
23. SAICU. Vaccine safety reports from 1 January to 30
June 2002. Bulletin CDC 2002;11:1-8.
Geneva: WHO; 1998. p. 62.
2. The National Vaccine Advisory Committee. Strate-
gies to sustain success in childhood immunizations.
JAMA 1999; 282:363-9.
3. National Health and Medical Research Council. The
Australian immunisation handbook. 6th ed. Canberra:
NHMRC; 1997. p. 1-17.
4. Hadinegoro SR. Imunisasi pada anak: state of the art.
Presented at Kongres PETRI V; 1999 Nov 19-21;
Makassar.
5. Ward BJ. Vaccine adverse events in the new millen-
nium: is there reason for concern? Bull World Health
Organ 2000;78:205-15.
6. Chen RT. Safety of vaccines. In: Plotkin SA, Orenstein
WA, editors. Vaccines. 3rd ed. Philadelphia: WB
Saunders; 1999. p. 1144-63.
7. Stratton KR, Howe CJ, Johnston RB. Adverse events
associated with childhood vaccines. Washington DC:
Institute of Medicine; 1994. p. 1-55.
8. Loupi E, Baudard S, Debois H, Pignato F. Risk associ-
ated with vaccinations. Ann Med Interne
1998;149:361-71.
9. Mehta U, Milstien JB, Duclos P, Folb PI. Developing a
national system for dealing with adverse events fol-
lowing immunization. Bull World Health Organ
2000;78:170-7.
10. Atkinson W, Wolfe C, Humiston S, Nelson R. Epide-
miology and prevention of vaccine-preventable dis-
eases. 6th ed. Georgia: Public Health Foundation;
2000. p. 144-63.
11. World Health Organization. Immunization safety sur-
veillance. Geneva: WHO; 1999. p. 9-38.
12. Hadinegoro SR. Kejadian ikutan pasca imunisasi. Sari
Pediatri 2000;2:2-10.
13. Komite Nasional Pengkajian & Penanggulangan
Kejadian Ikutan Pasca Imunisasi (KN-PP KIPI).
Pedoman tatalaksana medik kejadian ikutan pasca
imunisasi (KIPI) bagi petugas kesehatan. 4th ed.
Jakarta: Direktorat Jenderal PPM-PL Departemen
Kesehatan RI; 2002.
14. Chen RT, Glasser JW, Rhodes PH. Vaccine safety datalink
project: a new tool for improving vaccine safety monitor-
ing in the United States. Pediatrics 1997;99:765-73.
15. Du Vernoy TS, Braun MM. Hypotonic-hyporesponsive
episodes reported to the Vaccine Adverse Event Report-
ing System (VAERS), 1996-1998. Pediatrics
2000;106:E52.
16. Singleton JA, Lloyd JC. Mootrey GT, Salive ME, Chen
RT. An overview of the vaccine adverse reporting sys-
tem (VAERS) as a surveillance system. Vaccine
1999;17:2908-17.
17. WHO. Supplementary information on vaccine safety
part 2: background rates of adverse events following
immunization. Geneva: WHO; 2000. p. 1-5.
18. Lawrence G, Menzies R, Burgess M, McIntyre P, Wood
N, Boyd I, et al. Surveillance of adverse events following
immunisation: Australia, 2000–2002. Commun Dis
Intell 2003;27:307–23.
19. Zhou W, Pool V, Iskander JK, English-Bullard R, Ball R,
Wise RP, et al. Surveillance for safety after immuniza-
tion: vaccine adverse event reporting system (VAERS)–
United States, 1991-2001. MMWR 2003;52:1-13.
20. WHO. Supplementary information on vaccine safety
part 1: field issues. Geneva: WHO; 2000. p. 3-9.
21. WHO. Global action plan for laboratory containment
of wild polioviruses. 2nd ed. Geneva: WHO; p. 4-6.
22. Kosen S. Study on safe injection practice in immuni-
zation campaign for schoolchildren (BIAS). A report
prepared for the Sub Directorate of Epidemiology and
Immunization, Directorate General of CDC and AHG,
MOH. Rep of Indonesia and the World Health Orga-
nization; 1999.
23. SAICU. Vaccine safety reports from 1 January to 30
June 2002. Bulletin CDC 2002;11:1-8.
Published
2016-10-10
How to Cite
1.
Kaswandani N, Hadinegoro S, Suradi R. Adverse events following immunization (AEFI) reports of extended program immunization (EPI) in Indonesia during 1998-2002. PI [Internet]. 10Oct.2016 [cited 20Apr.2024];44(4):153-. Available from: https://paediatricaindonesiana.org/index.php/paediatrica-indonesiana/article/view/755
Section
Articles
Authors who publish with this journal agree to the following terms:
Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal.
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.
Received 2016-09-30
Accepted 2016-09-30
Published 2016-10-10
Accepted 2016-09-30
Published 2016-10-10
