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UNPROTECTED PEOPLE: Stories of
people who have suffered or died from vaccine-preventable diseases
INFANT DIES OF FULMINANT HEPATITIS B, 1999
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The following case report and discussion appeared in the
Spring/Summer 2000 issue of NEEDLE TIPS.
On December 13, 1999, a previously healthy 3-month-old infant of Southeast Asian descent was brought to a local
Michigan hospital emergency department and was admitted following a 5-day history of fever, diarrhea, and
Upon admission to the hospital, hepatitis B serology was obtained along with
liver function tests and liver enzymes. Laboratory results revealed that the
infant was hepatitis B surface antigen (HBsAg) positive and IgM core antibody
(IgM anti-HBc) positive with elevated total bilirubin 16.6, direct bilirubin 4.7,
ALT 693, and AST 203. The infant's test results were reported to the local health department on December 14, 1999. The infant's
mother was tested at the same time and was found to be HBsAg positive and anti-HBc positive.
A diagnosis of hepatic failure due to hepatitis B virus infection was made and
the infant was transferred to another hospital on December 16 for possible liver
transplantation. After transfer, the infant developed seizures and her condition deteriorated rapidly. She died
on December 17.
Investigation revealed that the infant's mother had tested positive for HBsAg
during her pregnancy but that the test result was communicated incorrectly as
"hepatitis negative" to the hospital where the baby was born. Neither the laboratory nor the prenatal care provider reported the
HBsAg-positive test results to the local health department as required by state law. The infant
received no hepatitis B vaccine and no hepatitis B immune globulin (HBIG) at
the time of birth.
The hospital where the infant was born had suspended administration of hepatitis B vaccine to all newborns
during the summer of 1999 due to the concern about the presence of thimerosal used as a preservative in hepatitis
B vaccine. The first dose of hepatitis B vaccine wasn't administered to this
infant until two months of age. This tragedy could have been averted.
Serious medical errors occurred in this case resulting in the death of the infant. The following errors occurred:
- The HBsAg-positive test result was not conveyed to the
pregnant woman by her physician.
- The physician failed to report the HBsAg-positive test
result to the local health department as mandated by state law.
- The laboratory that performed the test did not notify
the local health department of the positive result.
- The HBsAg test result was transcribed incorrectly on
the prenatal record that was sent to the hospital. A copy of the original lab report did not
accompany the prenatal record.
- The HBsAg test result was not verified by the perinatal
staff; they did not review a copy of the actual lab report.
- There was no hospital protocol in place to vaccinate
infants who live in communities at high risk for early HBV exposure.
TAKE MEASURES TO ASSURE THAT ERRORS SUCH AS THESE DO NOT
OCCUR IN YOUR PRACTICE OR HOSPITAL.
If you provide prenatal care:
- Test every pregnant woman during each pregnancy for
HBsAg, regardless of her hepatitis B vaccination status.
- Send a copy of the original lab report along with other
prenatal records to the hospital where the woman will deliver.
- Notify the local or state health department of any
positive HBsAg test result in a pregnant woman.
- Counsel the pregnant woman about the implications of her
positive HBsAg test result (i.e., the need for her to receive ongoing medical
evaluation and the need for household and sexual contacts to be tested
- Communicate the woman's positive HBsAg status to the
clinician who will provide pediatric care to the newborn.
If you work in a hospital labor & delivery unit or newborn
- Know the HBsAg status of every woman giving birth in
your facility. A copy of the original lab report should be part of the prenatal record.
- Don't let any infant slip through the cracks. Administer
the first dose of hepatitis B vaccine in the hospital to all newborns. Ample supplies of
preservative-free hepatitis B vaccine are available for all children.
- Develop hospital policies to assure that all mothers are
screened for HBsAg and all newborns are appropriately managed to prevent HBV
If you provide pediatric care to newborns:
- Know the HBsAg status of the mothers of all infants for
whom you provide care.
- Help assure that no babies are infected due to a medical
error. Make sure that all newborns under your care receive the first dose of hepatitis
B vaccine at birth.
- In addition to an HBsAg-positive mother, know the risk
groups for HBV infection.
Manager, Outreach and Education Section
Division of Immunization
State of Michigan Department of Community Health
For more information on how to prevent hepatitis B in infants, check out the Immunization Action Coalition's
"Labor & Delivery Unit and Nursery Unit Guidelines to Prevent HBV Transmission," which has been reviewed by the
Centers for Disease Control and Prevention.
For a camera-ready (PDF format) version of this document,
go to: http://www.immunize.org/catg.d/p2130per.pdf
For the text version (HTML format) of this document, go to: http://www.immunize.org/catg.d/p2130.htm
Also read "Be as Sure as You Can Be! Give Babies Hepatitis B Vaccine at Birth" by Harold S. Margolis, MD, Chief of
the Hepatitis Branch, National Center for Infectious Diseases at the Centers for Disease Control and
For a camera-ready (PDF format) version of this document, go to: http://www.immunize.org/nslt.d/n23/besure.pdf
For the text version (HTML format) of this document, go to: http://www.immunize.org/nslt.d/n23/besure23.htm
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if you have personal stories, or if you know of stories that have appeared in the media, that describe the
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