Characteristics of Adverse Events Following Immunization Reporting in Children: The Japanese Adverse Drug Event Report Database
Abstract
:1. Introduction
2. Materials and Methods
3. Results
3.1. Characteristics of the Reports in the JADER
3.2. Outcomes Associated with AEFI Reports
3.3. Ten Most Frequently Reported Vaccines
3.4. Ten Most Frequently Reported Reactions
3.5. Ten Most Frequently Reported Vaccine–Reaction Pairs
4. Discussion
5. Conclusions
Author Contributions
Funding
Acknowledgments
Conflicts of Interest
References
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Characteristics | Age Group | p | |
---|---|---|---|
<10 Years a n (%) | 10–19 Years b n (%) | ||
Sex | |||
Boy | 2272 (53.7) | 208 (10.1) | <0.0001 |
Girl | 1801 (42.6) | 1838 (89.7) | |
Unknown | 157 (3.7) | 4 (0.2) | |
The type of report sender | |||
Pharmaceutical company | 4155 (98.2) | 2047 (99.9) | <0.0001 |
Healthcare facility | 75 (1.8) | 3 (0.1) | |
The qualifications of the reporter | |||
Doctor | 3548 (73.7) | 1807 (58.0) | <0.0001 |
Pharmacist | 157 (3.3) | 99 (3.2) | |
Healthcare professional | 358 (7.4) | 201 (6.5) | |
Consumer | 335 (7.0) | 919 (29.5) | |
Lawyer | 0 (0.0) | 21 (0.7) | |
Unknown | 414 (8.6) | 67 (2.2) | |
Total c | 4812 (100) | 3114 (100) | - |
No. of suspected vaccines per AEFI report | |||
1 | 2673 (63.2) | 2028 (98.9) | <0.0001 |
2 | 554 (13.1) | 22 (1.1) | |
3 | 485 (11.5) | 0 (0.0) | |
4 | 347 (8.2) | 0 (0.0) | |
≥5 | 171 (4.0) | 0 (0.0) | |
Total | 4230 (100) | 2050 (100) | - |
Outcomes associated with AEFI report | |||
Cured | 3934 (52.6) | 3734 (44.3) | <0.0001 |
Recovering | 1585 (21.2) | 1024 (12.2) | |
Did not recover | 276 (3.7) | 1776 (21.1) | |
Recovering with sequelae | 91 (1.2) | 51 (0.6) | |
Death | 321 (4.3) | 15 (0.2) | |
Unknown | 1272 (17.0) | 1826 (21.7) | |
Total d | 7479 (100) | 8426 (100) | - |
<10 Years | n (%) |
Vaccine Name a | |
Haemophilus influenzae type b conjugate vaccine (monovalent) | 1438 (19.2) |
Pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) | 1163 (15.5) |
Live attenuated human rotavirus vaccine, oral (monovalent) | 775 (10.3) |
Pneumococcal 7-valent conjugate vaccine (diphtheria CRM197 protein) | 616 (8.2) |
Adsorbed diphtheria-purified pertussis-tetanus-inactivated polio (Sabin strain) combined vaccine | 521 (7.0) |
Influenza hemagglutinin vaccine | 517 (6.9) |
Recombinant adsorbed hepatitis B vaccine (yeast derived) | 412 (5.5) |
Rotavirus vaccine, live, oral, pentavalent | 376 (5.0) |
Freeze-dried live attenuated mumps virus vaccine | 313 (4.2) |
Freeze-dried bacillus Calmette–Guérin vaccine | 267 (3.6) |
Adverse reactions b | |
Pyrexia | 731 (9.9) |
Hematochezia | 317 (4.3) |
Intussusception | 314 (4.3) |
Seizure | 245 (3.3) |
Pneumococcal bacteremia | 193 (2.6) |
Immune thrombocytopenic purpura | 190 (2.6) |
Anaphylactic reaction | 188 (2.6) |
Meningitis aseptic | 179 (2.4) |
Vomiting | 178 (2.4) |
Febrile convulsion | 173 (2.3) |
10–19 years | n (%) |
Vaccine name c | |
Recombinant adsorbed bivalent human papillomavirus-like particle vaccine (derived from Trichoplusia ni cells) | 1361 (65.7) |
Recombinant adsorbed quadrivalent human papillomavirus virus-like particle vaccine (yeast origin) | 295 (14.2) |
Influenza hemagglutinin vaccine | 164 (7.9) |
Freeze-dried live attenuated mumps virus vaccine | 90 (4.3) |
Freeze-dried live attenuated measles and rubella combined vaccine | 50 (2.4) |
Freeze-dried, cell culture-derived Japanese encephalitis vaccine | 31 (1.5) |
Adsorbed diphtheria–tetanus combined toxoid | 30 (1.4) |
Japanese encephalitis vaccine (not otherwise specified) | 11 (0.5) |
Recombinant adsorbed hepatitis B vaccine (yeast derived) | 10 (0.5) |
Dried live attenuated measles vaccine | 9 (0.4) |
Adverse reactions d | |
Syncope | 312 (3.8) |
Loss of consciousness | 308 (3.8) |
Headache | 297 (3.6) |
Presyncope | 287 (3.5) |
Seizure | 233 (2.8) |
Malaise | 196 (2.4) |
Pyrexia | 193 (2.4) |
Pain | 178 (2.2) |
Hypoesthesia | 148 (1.8) |
Dizziness | 146 (1.8) |
Generic Name | Adverse Reactions | n (%) |
---|---|---|
<10 Years | ||
Haemophilus influenzae type b conjugate vaccine | Pyrexia | 357 (2.6) |
Live attenuated human rotavirus vaccine, oral | Hematochezia | 278 (2.1) |
Pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) | Pyrexia | 234 (1.7) |
Pneumococcal 7-valent conjugate vaccine (diphtheria CRM197 protein) | Pyrexia | 199 (1.5) |
Pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) | Pneumococcal bacteremia | 186 (1.4) |
Live attenuated human rotavirus vaccine, oral | Intussusception | 182 (1.3) |
Freeze-dried live attenuated mumps virus vaccine | Meningitis aseptic | 162 (1.2) |
Live attenuated human rotavirus vaccine, oral | Pyrexia | 161 (1.2) |
Rotavirus vaccine, live, oral, pentavalent | Intussusception | 130 (1.0) |
Adsorbed diphtheria-purified pertussis-tetanus-inactivated polio (Sabin strain) combined vaccine | Pyrexia | 129 (1.0) |
10–19 years | ||
Recombinant adsorbed bivalent human papillomavirus-like particle vaccine (derived from Trichoplusia ni cells) | Loss of consciousness | 277 (3.4) |
Syncope | 270 (3.3) | |
Presyncope | 269 (3.3) | |
Headache | 180 (2.2) | |
Seizure | 152 (1.8) | |
Depressed level of consciousness | 135 (1.6) | |
Malaise | 132 (1.6) | |
Pyrexia | 122 (1.5) | |
Pain | 120 (1.5) | |
Arthralgia | 108 (1.3) |
Generic Name | Adverse Reactions | n (%) |
---|---|---|
<10 years | ||
Haemophilus influenzae type b conjugate vaccine | Cardio-respiratory arrest | 51 (4.3) |
Haemophilus influenzae type b conjugate vaccine | Sudden infant death syndrome | 39 (3.3) |
Pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) | Cardio-respiratory arrest | 30 (2.5) |
Haemophilus influenzae type b conjugate vaccine | Death | 29 (2.4) |
Adsorbed diphtheria-purified pertussis-tetanus-inactivated polio (Sabin strain) combined vaccine | Cardio-respiratory arrest | 23 (1.9) |
Pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) | Sudden infant death syndrome | 21 (1.8) |
Haemophilus influenzae type b conjugate vaccine | Respiratory arrest | 21(1.8) |
Pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) | Death | 20 (1.7) |
Pneumococcal 7-valent conjugate vaccine (diphtheria CRM197 protein) | Cardio-respiratory arrest | 19 (1.6) |
Adsorbed diphtheria-purified pertussis-tetanus-inactivated polio (Sabin strain) combined vaccine | Sudden infant death syndrome | 18 (1.5) |
Pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) | Sudden infant death syndrome | 18 (1.5) |
10–19 years | ||
Recombinant adsorbed bivalent human papillomavirus-like particle vaccine (derived from Trichoplusia ni cells) | Ventricular fibrillation | 2 (6.7) |
Respiratory failure | 2 (6.7) | |
Altered state of consciousness, Bulbar palsy, Ventricular tachycardia, Amyotrophic lateral sclerosis, Cardio-respiratory arrest, Bundle branch block left, Musculoskeletal stiffness, Tension headache, Sinus arrhythmia, Electroencephalogram abnormal, Osteosarcoma, Loss of consciousness, Ventricular arrhythmia, Dyspnoea, Completed suicide, Arrhythmia supraventricular, Respiratory arrest, Muscular weakness, Seizure, Ventricular extrasystoles | 1 (3.3) for each adverse reaction | |
Influenza HA vaccine | Myocarditis | 1 (3.3) |
Freeze-dried, Cell Culture-derived Japanese. Encephalitis Vaccine | Syncope | 1 (3.3) |
Freeze-dried live attenuated measles and rubella combined vaccine | Cardio-respiratory arrest | 1 (3.3) |
Pneumococcal vaccine | Pneumococcal infection, Post procedural infection, Sudden death | 1 (3.3) for each adverse reaction |
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Noda, A.; Sakai, T.; Tsuchiya, M.; Oyanagi, G.; Obara, T.; Mano, N. Characteristics of Adverse Events Following Immunization Reporting in Children: The Japanese Adverse Drug Event Report Database. Vaccines 2020, 8, 357. https://doi.org/10.3390/vaccines8030357
Noda A, Sakai T, Tsuchiya M, Oyanagi G, Obara T, Mano N. Characteristics of Adverse Events Following Immunization Reporting in Children: The Japanese Adverse Drug Event Report Database. Vaccines. 2020; 8(3):357. https://doi.org/10.3390/vaccines8030357
Chicago/Turabian StyleNoda, Aoi, Takamasa Sakai, Masami Tsuchiya, Gen Oyanagi, Taku Obara, and Nariyasu Mano. 2020. "Characteristics of Adverse Events Following Immunization Reporting in Children: The Japanese Adverse Drug Event Report Database" Vaccines 8, no. 3: 357. https://doi.org/10.3390/vaccines8030357
APA StyleNoda, A., Sakai, T., Tsuchiya, M., Oyanagi, G., Obara, T., & Mano, N. (2020). Characteristics of Adverse Events Following Immunization Reporting in Children: The Japanese Adverse Drug Event Report Database. Vaccines, 8(3), 357. https://doi.org/10.3390/vaccines8030357