Table 4. System Organ Class distribution for all reported AEFI1 and SAE2 for vaccines administered from 2005−2012 (the average % distribution is shown for 2005−2010).
| System Organ Class | % of AEFI reports with at least one SOC term3 | ||
|---|---|---|---|
| 2005−2010 | 2011 | 2012 | |
| Blood and lymphatic system disorders | 2.1 | 2.7 | 1.9 |
| Cardiac disorders | 1 | 1.4 | 1.6 |
| Congenital, familial and genetic disorders | 0 | 0 | 0 |
| Ear and labyrinth disorders | 0.6 | 0.9 | 1.1 |
| Endocrine disorders | 0 | 0 | 0.1 |
| Eye disorders | 5.7 | 6.7 | 6.6 |
| Gastrointestinal disorders | 14.9 | 19.3 | 20.2 |
| General disorders and administration site conditions | 61.2 | 66.6 | 66.7 |
| Hepatobiliary disorders | 0.1 | 0.1 | 0.1 |
| Immune system disorders | 5.8 | 8.9 | 14.0 |
| Infections and infestations | 7.0 | 10.1 | 11.5 |
| Injury, poisoning and procedural complications | 1.8 | 3.3 | 3.1 |
| Investigations | 6.9 | 4.6 | 2.9 |
| Metabolism and nutrition disorders | 3.4 | 3.9 | 3.9 |
| Musculoskeletal and connective tissue disorders | 8.4 | 10.6 | 10.3 |
| Neoplasms benign, malignant and unspecified (including cysts and polyps) | 0 | 0 | 0 |
| Nervous system disorders | 19.5 | 20.4 | 21.6 |
| Pregnancy, puerperium and perinatal conditions | 0.1 | 0 | 0 |
| Psychiatric disorders | 2.6 | 2.2 | 2.1 |
| Renal and urinary disorders | 0.2 | 0.3 | 0.4 |
| Reproductive system and breast disorders | 0.2 | 0.1 | 0.3 |
| Respiratory, thoracic and mediastinal disorders | 9.3 | 11.8 | 11.4 |
| Skin and subcutaneous disorders | 35.2 | 40.0 | 37.6 |
| Social circumstances | 0.2 | 0.1 | 0.1 |
| Surgical and medical procedures | 0.1 | 0.1 | 0 |
| Vascular disorders | 3.1 | 3.4 | 4.2 |
1 Adverse event following immunization (AEFI) 2 Serious Adverse Event (SAE) 3 Each AEFI report can have multiple AEFI terms falling into different System Organ Class (SOC) categories so the total for each vaccination period will exceed 100% of reports.