Table 5.
MedDRAa preferred terms most commonly reported among reports where an excess dose of vaccine was administered compared to the rest of the VAERS database, January 2007–July 2017b.
| MedDRA PT | Excess dose | VAERS database |
|---|---|---|
| N = 1,169 | N = 301,805 | |
| N (%) | N (%) | |
| Pyrexia | 150 (12.8) | 44,574 (14.8) |
| Injection site erythema | 113 (9.7) | 48,767 (16.2) |
| Injection site pain | 104 (8.9) | 33,183 (11.0) |
| Headache | 77 (6.6) | 24,455 (8.1) |
| Injection site swelling | 76 (6.5) | 36,419 (12.1) |
| Pain in extremity | 75 (6.4) | 24,375 (8.1) |
| Pain | 69 (5.9) | 29,143 (9.7) |
| Vomiting | 61 (5.2) | 16,824 (5.6) |
| Nausea | 52 (4.4) | 18,997 (6.3) |
| Dizziness | 51 (4.4) | 19,221 (6.4) |
| Fatigue | 50 (4.3) | 14,836 (4.9) |
| Cough | 46 (3.9) | 9487 (3.1) |
| Irritability | 46 (3.9) | 5707 (1.9) |
| Erythema | 43 (3.7) | 30,811 (10.2) |
| Rash | 43 (3.7) | 22,044 (7.3) |
a
MedDRA: Medical Dictionary for Regulatory Activities.
b
Reports with no adverse health events reported were excluded.