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Administered by: Other Purchased by: Other
Life Threatening? Yes
Write-up: Information has been received from a physician for the pregnancy registry for GARDASIL concerning a 22 year old female with bacterial vaginosis who was vaccinated intramuscularly with the first 0.5 dose of GARDASIL in the left upper arm in August 2008 her first month of previous pregnancy, reported in (WAES # 0809USA00445), the second dose of GARDASIL in her right upper arm in October 2008 with no other vaccines was given on this date and the third dose of vaccine on her left arm on 04-NOV-2009. Concomitant therapy included 250 mg FLAGYL for bacterial vaginosis infection, folic acid 3 weeks after the visit and the flu vaccine in her right arm. The patient delivered a male child by caesarean section due to gastroschisis 3 months ago. Child had complication gastroschisis, abdominal defect, which required surgery and longer stay at the hospital after birth. Child was being seen by specialist. Follow up information was received from the physician concerning the patient with no obstetric history as well as no medical history or concurrent conditions who was vaccinated with her first, second and third dose of GARDASIL on 05-AUG-2008, 09-OCT-2008 and 04-NOV-2009 respectively. Concomitant therapy included FLAGYL folic acid from 07-AUG-2008 and influenza virus vaccine on 04-NOV-2009. Amniocentesis indicated that the patient was 4.5 months pregnant (LMP: 12-AUG-2008; EDD: 19-MAY-2009). The results of the amniocentesis were "negative". On 12-AUG-2009, at 25 weeks of gestation, the patient delivered an abnormal male baby weighting 4 pounds, 18 cm in length with head circumference of 35. The baby was born by caesarean section with gastroschisis. The mother had not complication during pregnancy and needed caesarean section because of the baby''s gastrochisis. The mother did not experience any infections or illnesses during pregnancy. The infant was still in NICU as of today. Other medication used during this pregnancy included prenatal vitamin, 1 tablet, daily. Follow up information was received from the physician via telephone on 09-NOV-2009 concerning the patient received the second pregnancy and had an outcome of a 3 month premature delivery with a baby with gastroschisis. It was reported that LMP was not known and the patient conceived sometime in February 2009, ast least 2 months after receiving her second dose of vaccine. The physician arrived at this approximate date working backwards from her Cesarean delivery date of 14-AUG-2009 (also reported baby was born on 12-AUG-2009) three months "early". It was reported that the baby had had surgery (date not provided) for gastroschisis, was still in NICU, had gained weight and was "doing well". He also said the mother had recovered from her Cesarean she was doing fine. This is an amended report. The word "previous" before the word pregnancy in the sentence in the first paragraph regarding the other pregnancy/WAES# for this patient was added. "Other medication used during this pregnancy included prenatal vitamin, 1 tablet daily" was added in the third paragraph in the narrative. Bacterial vaginosis was added as a concurrent condition. The mother''s experience has been captured in WAES# 0911USA01240B1. The reporter considered gastroschisis, premature and small for dates baby to be disabling and life threatening and gastroschisis to be other important medical events. This information was previously sent in WAES# 0911USA01240 on 04-DEC-2009. Additional information had been requested. This information was previously sent in WAES# 0911USA01240 on 04-DEC-2009.
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