Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Hepatitis B surface antigen negative, Labour complication, Rubella immunity confirmed, Syphilis test negative, Ultrasound scan abnormal
Clinical narrative: Initial report received on 27 December 2008, from a physician, as part of a study for which is not a sponsor. A 38-year-old pregnant female experienced "A2" gestational diabetes after receiving on 04 May 2006 a first intramuscular, left deltoid injection of ADACEL. The patient began her current pregnancy as a twin pregnancy, and complications of pregnancy at the time of vaccination, revealed twin A had already expired at 10 weeks gestation on 29 March 2006. The patient took PEPCID, and prenatal vitamins throughout the pregnancy, and VICODIN occasionally throughout the pregnancy. The patient took Glyburide from 20 August 2006 to 20 October 2006, for gestation diabetes type A2. The patient's past obstetric history included two previous pregnancies that resulted in one live birth with no congenital anomalies and one spontaneous abortion prior to 20 weeks gestation. At the time of vaccination, the patient had current medical history of Body Mass Index of 29, past history of exercise induced asthma, history of malignant melanoma, right shoulder (1993) that was removed by wide local excision, a hiatal hernia causing gastroesophageal reflux disease, cholecystectomy (1999), motor vehicle accident (1990), resulting in compression fracture L2 vertebrae, and spondylolisthesis L5-S1, causing severe chronic low back and hip pain. The patient has no history of alcohol use, drug use, or tobacco use. Regarding the current pregnancy, the date of the patient's last menstrual period was on 17 January 2006, with an expected date of delivery on 27 October 2006. The patient had serology testing on 23 May 2005 and 05 September 2005, that were normal with O+, Rubella Imm, HIV Neg, RPR-NR, HGsAG-NR, and Gc/chlam-Neg/neg. A fetal stress test on 11 September 2006, started bi-weekly, non-stress testing at 34 weeks for A2 gestational diabetes. Eleven more fetal stress tests were performed from 11 September 2006 to 19 October 2006, that were normal. An ultrasound on 27 February 2006, revealed twin gestation; and ultrasound on 06 March 2006, revealed lagging growth of twin A; an ultrasound on 29 March 2006, revealed demise of twin A. Subsequently, three ultrasounds were performed from 24 May 2006 to 20 October 2006, that showed normal morphology and growth of twin B, and normal amniotic fluid index. The patient experienced complication of labor and was induced at 40+ weeks of gestation for gestational diabetes Mellitus Type A2. The patient delivered one live female baby via vaginal delivery at 40+ weeks. The baby's Apgar score were six at one minute, and nine at five minutes. The birth weight was 3290g (3 kilogram); and the baby did not suffer any congenital anomalies. At the time of the report, the patient was considered to be recovered. Documents held by sender: None. The reporter for this case is the same as in case numbers: 2008-04101, 2008-04102,2008-04103, 2008-04104, 2008-04105, 2008-04106, 2008-04107, 2008-04108, 2008-04109, 2008-04111, 2008-04112, 2008-04113, 2008-04114, 2008-04115, and 2008-04116.