TABLE 2

Serious and Nonserious AEs (N = 50 157) in DTaP Recipients Reported to VAERS, 1991–2016

MedDRA Code, SeverityaN (%)
Serious5476 (100)
 Pyrexia1959 (34.8)
 Vomiting1565 (27.8)
 Irritability1238 (22.0)
 Convulsion939 (16.7)
 Intussusception817 (14.5)
 Crying761 (13.5)
 Diarrhea747 (13.3)
 Lethargy648 (11.5)
 Hypotonia567 (10.1)
 Cough560 (10.0)
Nonserious44 530 (100)
 Injection site erythema12 444 (27.9)
 Pyrexia7954 (17.9)
 Injection site swelling7349 (16.5)
 Erythema5345 (12.0)
 Injection site warmth4670 (10.5)
 Injection site edema3186 (7.2)
 Injection site pain3124 (7.0)
 Injection site induration3084 (6.9)
 Rash2932 (6.6)
 Urticaria2800 (6.3)
  • a The MedDRA codes reflect the 10 most frequent codes appearing in serious and nonserious 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 PT.