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Last Updated:
12 Nov 14

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ADVERSE EVENT INFO

Pregnancy Considerations

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Giving large numbers of smallpox vaccines in the military, we recognize that, despite extensive efforts to prevent it, we inadvertently may vaccinate some pregnant women. DoD, in cooperation with CDC, has developed a Registry to track such cases. Please use the VAERS supplemental form to report cases to the Registry. Please send these forms, even if incomplete, with basic contact information for follow-up. For the first report on women enrolled in the Smallpox Vaccine in Pregnancy Registry, read this article from the CDC's Morbidity & Mortality Weekly Report (MMWR), 2 May 03.

We expect the vast majority of pregnancies to be unaffected by smallpox vaccination. The Military Vaccine (MILVAX) Agency developed an information paper to help providers and women inadvertently vaccinated, and address the complicated question of possible value of vaccinia immune globulin (VIG), if an unknown pregnancy is discovered after the vaccine has been given. Please note that VIG should only be considered in cases when less than 10 days (certainly less than 14 days) have elapsed since vaccination. If the vaccinia has not affected the unborn baby by that time, it is unlikely to do so.

Finally, please consider the following: For us to better understand the potential effects of the vaccine during early pregnancy, it may be helpful to collect the remains of miscarriages, if any occur among those vaccinated against smallpox during or just before pregnancy. The testing would help see if vaccinia virus is present. This is only a suggestion. Labs should preserve any specimens frozen at -70C, preferably in viral-transport medium (VTM).

POCs for questions:

Smallpox Vaccine in Pregnancy Registry
(619)553-9255, DSN 553-9255, Fax (619)553-7601
email: nhrc-birthregistry@med.navy.mil

Vaccine Healthcare Center Network
(202)782-0411, DSN 662-0411, Fax (202)782-4658
email: askVHC@amedd.army.mil

DoD uses four screening checks to avoid giving smallpox vaccine to a pregnant woman:

(1) Servicemembers eligible for smallpox vaccination attend a class at which they are informed of the reasons to be exempted from smallpox vaccination, including pregnancy. See slides 14 and 15 at: Smallpox Individual's Briefing

(2) Servicemembers eligible for smallpox vaccination receive written brochures describing the reasons not to be vaccinated against smallpox, including pregnancy. See: Smallpox Trifold Brochure

(3) Before receiving smallpox vaccination, Servicemembers answer two questions on screening forms: "Was your last menstrual period normal and on time?" And "Could someone you LIVE WITH or YOU be pregnant?" Any woman who says "yes" or "unsure" is exempted from vaccination until given a pregnancy test. Smallpox Vaccination Initial Note (Screening Form)

(4) Pregnancy testing is conducted if a woman requests a test or if a clinician orders one.