Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Pregnancy test positive, Serology normal, Ultrasound scan normal, Urinary tract infection
Clinical narrative: Initial report received on 02 June 2008 from a health care professional. A 28-year-old patient, had received a 0.5 mL intramuscular right deltoid injection of ADACEL (Lot number C2888AA), and a 0.1 mL intradermal left forearm injection of TUBERSOL (Lot number C2907BA) on 28 April 2008. The patient had past medical history of asthma (treated with ADVAIR), hypercholesterolemia and "reflux" (treated with ZANTAC). Past obstetrical history includes one  previous pregnancy that resulted in a spontaneous abortion at five months gestation. The following day after receiving the ADACEL and TUBERSOL, the patient developed swelling at the ADACEL injection site. Treatments received and diagnostic tests performed were not provided. The subject recovered (date not reported). Subsequently on 29 May 2008, the patient did a home pregnancy test that was positive. At the time of this report no prenatal tests had been done. The date of the patient's last menstrual period was reported as April 2008, and the expected date of delivery was unknown. 28 July 2008: Corrective version was created to remove the "no adverse effect" from the adverse event structure field, since the patient had developed swelling at the ADACEL injection site. Follow-up information received from a health care professional on 28 August 2008. For the adverse event "swelling at the ADACEL injection site", extent of swelling was reported to be minimal (less than nickel sizes), and resolved in one day. Follow-up information concerning the patient's pregnancy was also reported. The date of the patient's last menstrual period was reported as March 2008. Estimated date of delivery is 20 January 2009. The patient denied alcohol, drug or tobacco use. At the time of the report, the patient was reported to be healthy. It was reported that per the patient, things were going well with the pregnancy. An ultrasound was performed in August 2008 with normal results. Follow-up information was received 25 September 2008 from a health care professional. The reporter confirmed that the swelling at the injection site had resolved on 30 April 2008. Follow-up information received on 06 February 2009 from a physician. It was clarified the patient, who, had delivered her first child at 20 weeks gestation and the baby subsequently died. It was previously reported the patient had experienced a spontaneous abortion at 20 weeks gestation. Per the reporter, the patient has no family history of congenital anomalies. the date of the patient's last menstrual period was amended by the reporter from 01 March 2008 to an unknown day in April 2008 with an expected date of delivery on 24 January 2009. The patient took prenatal vitamins during the current pregnancy. The date of vaccination for the ADACEL, and the date of TUBERSOL test was amended from 28 April 2008 to 02 June 2008 by the reporter. Regarding the current pregnancy, the patient did not smoke cigarettes, drink alcohol, or use any recreational drug during her pregnancy. The patient's prenatal tests included serology tests on 03 July 2008 that were normal and ultrasounds that were normal on 20 August 2008, 10 September 2008, 30 October 2008, 04 December 2008 and 31 December 2008. The patient developed gestational diabetes with a body mass index of 32, a urinary tract infection that was treated with oral MACROBID 100 mg for seven days from 13 October 2008 to 20 October 2008, and exacerbation of her asthma from 24 June 2008 to delivery on 17 January 2009. The patient delivered via cesarean section at 39 weeks gestation a healthy live male baby with no congenital anomalies. The baby weighed six pounds 15 ounces (2.78kg). The Apgar scores were not provided. Pregnancy complications were listed as gestational diabetes and asthma; however the reporter ticked "no" for adverse events experienced since being vaccinated with ADACEL and receiving the TUBERSOL test. The recovery status of the gestational diabetes and exacerbation of asthma were not reported. The recovery status of the case was amended from recovered to "not reported." From this new information received, it was decided this case met the criteria for serious. This case was upgraded to serious. Documents held by sender: None.