Table 1.
Characteristics of the Vaccine Adverse Event Reporting System (VAERS) reports following receipt of 2009 H1N1 vaccine in pregnant women October 1, 2009 through February 28, 2010 United States (n=294).
| Characteristic | |
|---|---|
| Serious reports | 20.4% (60/294) |
| Deaths | 0.7% (2/294) |
| Maternal age in years (median [range]) a | 30.0 (15.0 – 46.0) |
| Onset interval in daysb (median [range]) | 2.0 (0 – 84.0) |
| Gestational age in weeks at time of vaccination, median (range) c | 13.0 (3.0 –39.0) |
| Gestational age at time of vaccination (n=247) | |
| First trimester (0 – 13 weeks) | 53.9% (133/247) |
| Second trimester (14 – 27 weeks) | 27.1% (67/247) |
| Third trimester (28 + weeks) | 19.0% (47/247) |
| Type of reporter | |
| Patient | 45.6% (134/294) |
| Vaccine provider | 39.1% (115/294) |
| Other | 11.6% (34/294) |
| Healthcare provider | 2.4% (7/294) |
| Manufacturer | 0.6% (2/294) |
| 2009 H1N1 vaccine given on the same day as seasonal influenza vaccine (%) | 10.5% (31/294) |
| No. MedDRAd terms coded for all reports | 2182 |
| Median No. MedDRA terms per report | 6.0 |
a
Age missing for one pregnant woman. One neonate report not included for age calculation.
b
Onset unknown for 19 reports. Onset is the difference between date of onset of adverse event and vaccination date.
c
Gestational age determined at time of vaccinationGestational age determined at time of vaccination. Gestational age unknown for 49 reports.
d
The Medical Dictionary for Regulatory Activities (MedDRA) was used to code symptoms and/or conditions described in each report.