Table 2.
Serious and Non-serious Adverse Events (N=50,157) in DTaP recipients Reported to the Vaccine Adverse Event Reporting System, 1991–2016
| MedDRA Code, Severitya | N (%) |
|---|---|
| Serious | 5,476 (100) |
| Pyrexia | 1,959 (34.8) |
| Vomiting | 1,565 (27.8) |
| Irritability | 1,238 (22.0) |
| Convulsion | 939 (16.7) |
| Intussusception | 817 (14.5) |
| Crying | 761 (13.5) |
| Diarrhea | 747 (13.3) |
| Lethargy | 648 (11.5) |
| Hypotonia | 567 (10.1) |
| Cough | 560 (110.0) |
| Non-serious | 44,530 (100) |
| Injection site erythema | 12,444 (27.9) |
| Pyrexia | 7,954 (17.9) |
| Injection site swelling | 7,349 (16.5) |
| Erythema | 5,345 (12.0) |
| Injection site warmth | 4,670 (10.5) |
| Injection site edema | 3,186 (7.2) |
| Injection site pain | 3,124 (7.0) |
| Injection site induration | 3,084 (6.9) |
| Rash | 2,932 (6.6) |
| Urticaria | 2800 (6.3) |
a
The MedDRA codes reflect the 10 most frequent codes appearing in serious and non-serious reports made after receipt of DTaP vaccines. Reports for all licensed DTaP products included in this study have been combined and other vaccines may have been administered concomitantly with the DTaP vaccine. A report may contain ≥1 Preferred Term.