- Postmarketing Vaccine Adverse Event Reporting System (VAERS) data show no unexpected adverse events (AEs) related to 9-valent type HPV vaccine (Gardasil) (9vHPV) exposure among pregnant women.
Why this matters
- CDC does not recommend HPV vaccination in pregnant women, even though data have not causally linked HPV vaccine to AEs.
- Delay HPV vaccine initiation in pregnant women; if series have been initiated, wait until postbirth to resume series.
- Assure pregnant women with inadvertent exposure that no significant safety signals have emerged.
- 80 reports.
- 9vHPV was administered during first trimester in 75% (45/60) of reports with known gestational age.
- 73.2% (n=60) submitted due to vaccine exposure during pregnancy did not describe an AE.
- 3.7% (n=3) reported spontaneous abortion, 2.4% (n=2) vaginal bleeding.
- Infant outcomes: 1.2% (n=1) excessive weight loss, 1.2% (n=1) renal impairment/manifestations.
- 20.7% (n=17) vaccination error reports, including: 29.4% (n=5) incorrect administration, administration to inappropriately aged recipient, or inappropriate schedule, 11.8% (n=2) extra dose.
- AEs: injection site reaction (n=2), spontaneous abortion (n=1), polyhydramnios (n=1), proteinuria (n=1), unspecified (n=1).
- VAERS surveillance data review evaluating reports of pregnant women exposed to 9vHPV, 2014-2017.
- Funding: CDC.
- Incomplete data, some report inaccuracies.
- Inability to calculate AE rates.
- Under-, overreporting.