Table 2.
Diagnostic categories of non-death serious reports following Adenovirus Type 4 and Type 7 Vaccine, Live, Oral reports in U.S. military personnel to VAERS, October 2011 through July 2018.
| Diagnostic category | Military (N = 21) N (%) |
Military observational study4 (N = 17) N (%) |
Total (N = 38) N (%) |
|---|---|---|---|
| Nervous system disorders | 14 (66.7) | 3 (17.6) | 17 (44.7) |
| Guillain Barré syndrome | 10 | 2 | 12 |
| HNPP1 | 2 | 0 | 2 |
| Epilepsy | 1 | 1 | 2 |
| ADEM2 | 1 | 0 | 1 |
| Immune system disorders | 2 (9.5) | 8 (47.1) | 10 (26.3) |
| Anaphylactic shock | 0 | 8 | 8 |
| Hypersensitivity Type III reaction | 1 | 0 | 1 |
| Scleroderma | 1 | 0 | 1 |
| Injury and poisoning and procedural complications3 | 0 | 4 (23.5) | 4 (10.5) |
| Infections and Infestations | 1 (4.8) | 0 | 1 (2.6) |
| Blood and lymphatic disorders | 1 (4.8) | 0 | 1 (2.6) |
| Musculoskeletal and connective tissue disorders | 1 (4.8) | 0 | 1 (2.6) |
| Cardiac disorders | 0 | 1 (5.9) | 1 (2.6) |
| Renal and urinary disorders | 1(4.8) | 0 | 1 (2.6) |
| Gastrointestinal disorders | 0 | 1 (5.9) | 1 (2.6) |
| Psychiatric disorders | 1 (4.8) | 0 | 1 (2.6) |
1
HNPP = Hereditary Neuropathy with Liability to Pressure Palsy.
2
ADEM = acute disseminated encephalomyelitis.
3
Implicated medications: penicillin G and ibuprofen, pseudoephedrine, acet-aminophen for nonspecific symptoms.
4
Sentinel Surveillance Plan-FDA-mandated post-marketing study.