Table 3.
Most commonly reported adverse events1 following Adenovirus Type 4 and Type 7 Vaccine, Live, Oral in VAERS, October 2011-July 20182.
| Adverse event2 (all adenovirus vaccine reports) | N (%) |
|---|---|
| Among Non-serious3 Reports | N = 61 |
| Pruritus | 10 (16.4) |
| Rash | 10 (16.4) |
| Urticaria | 10 (16.4) |
| Anaphylactic shock | 9 (14.8) |
| Hypersensitivity | 6 (9.84) |
| Nausea | 6 (9.84) |
| Dizziness | 5 (8.2) |
| Dysphagia | 5 (8.2) |
| Flushing | 5 (8.2) |
| Chest pain | 4 (6.56) |
| Dyspnea | 4 (6.56) |
| Lip swelling | 4 (6.56) |
| Throat tightness | 4 (6.56) |
| Among Serious3 Reports | N = 39 |
| Guillain Barré syndrome | 12 (30.8) |
| Muscular weakness | 12 (30.8) |
| Gait disturbance | 11 (28.2) |
| Dyspnea | 9 (23.1) |
| Anaphylactic shock | 8 (20.5) |
| Cough | 8 (20.5) |
| Grip strength decreased | 8 (20.5) |
| Hypoaesthesia | 8 (20.5) |
| Paraesthesia | 8 (20.5) |
| Fatigue | 7 (17.9) |
| Nausea | 7 (17.9) |
| Pain in extremity | 7 (17.9) |
1
Adverse events are listed as MedDRA preferred terms (PTs).
2
A single report may contain more than one adverse event/PT (i.e., not mutually exclusive), therefore percentages may sum to greater than 100%.
3
Reports are classified as serious based on the Code of Federal Regulations if one of the following is reported: death, life-threatening illness, hospitalization or prolongation of hospitalization, permanent disability, or a congenital anomaly.