Table 2.
Reports of adverse events following Tdap vaccination during pregnancy during 2005-2010 and 2011-2015, VAERS
| Before Routine Recommendation for Tdap during Pregnancy (January 2005 – June 2010) a,b |
After Routine Recommendation for Tdap during Pregnancy (October 2011 – July 2015) |
|
|---|---|---|
| Total Tdap pregnancy reports | 132 | 392 |
| Trimester of vaccination | First - 85 (77%) Third - 4 (4%) |
First - 29 (8.7%) Third - 264 (79.2%) |
| Maternal age, median (range), years | 22 (13 - 42) | 29 (13 - 42) |
| Serious c adverse event | 6 (4.5%) | 27 (6.9%) |
| Stillbirth | 2 (1.5%) | 11 (2.8%) |
| Preterm birth | 2 (1.5%) | 11 (2.8%) |
| Spontaneous abortion | 22 (16.7%) | 4 (1.0%) |
| Major birth defects | 1 (0.8%) | 4 (1.0%) |
| Injection site reactions/arm pain | 6 (4.5%) | 47 (11.9%) |
| No adverse event | 55 (41.7%) | 182 (46.4%) |
a
Zheteyeva et al. Safety of Tdap in pregnancy. Am. J. Obstet Gynecol. 2012;207:59.e1-7
b
From 2008-2011. ACIP did not routinely recommend use of Tdap vaccine in pregnant women, but recommended that providers consider use in certain situations that included instances when a pregnant woman has insufficient tetanus or diphtheria protection until delivery, or is at increased risk for pertussis
c
Based on definition of the Code of Federal Regulations [11], if any of the following conditions occur: death, hospitalization, prolongation of hospitalization, life-threatening illness, persistent or significant disability