Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Gene mutation identification test negative, HIV test negative, Hepatitis B surface antigen negative, Premature labour, Rubella immunity confirmed
Clinical narrative: Foetal disorder; pre-term labor at 29 weeks gestation; Antibody test negative; Chlamydia identification test negative; HIV test negative; Hepatitis B surface antigen negative; Rubella immunity confirmed; Syphilis test negative; Ultrasound scan abnormal; pregnant female patient received adacel vaccine;  Initial report was received 27 December 2008 from an investigator as part of a study for which Sanofi Pasteur is not a sponsor.  The study is entitled, "Assessment of the Impact of Maternal Tdap Vaccination on Levels of Pertussis Antibody in Mothers at Delivery and Infants at Delivery and Before and After Infant DTaP Vaccination" and "Antibody Responses to Pertussis following Vaccination with Tetanus and Diphtheria Toxoids Absorbed Combined with Acellular Pertussis Vaccine".  This case is linked to cases 2008-04101, 2008-04102, 2008-04103, 2008-04104, 2008-04105, 2008-04106, 2008-04107, 2008-04108, 2008-04109, 2008-04110, 2008-04112, 2008-04113, 2008-04114, 2008-04115, 2008-04116 and 2009-00011. (same reporter)  This case involves a 28 year old pregnant female patient who had foetal disorder, pre-term labor at 29 weeks gestation with antibody test negative, chlamydia identification test negative (chlamydia test negative), human immunodeficiency virus (HIV) test negative, Hepatitis B surface antigen negative, rubella immunity confirmed, syphilis test negative (Treponema test negative) and Ultrasound scan abnormal, after the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (exposure during pregnancy).    The date of last menstrual period was reported as 24-Oct-2005. The estimated due date was 31-Jul-2006. The actual date of delivery was 23-Jul-2006.  The patient had medical history thalassemia minor trait (thalassaemia minor), two previous pregnancies (both had been live births with no congenital anomalies), body mass index (BMI) - 19.7 and no alcohol (ETOH), drugs or tobacco.   Past medical treatment, vaccination and family history were not reported. Concomitant medications included PRENATAL VITAMINS [MINERALS NOS, VITAMINS NOS] throughout pregnancy.  On 03-May-2006, the patient received a first dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [suspension for injection, lot C2456A, expiry date not reported] via an intramuscular route at the left deltoid for prophylactic vaccination.  On an unknown date, the patient developed a serious foetal disorder (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant. On an unknown date the patient developed a non-serious pre-term labor at 29 weeks gestation (premature labour) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unknown date, the patient had a non-serious antibody test negative, chlamydia identification test negative (chlamydia test negative), human immunodeficiency virus (HIV) test negative, Hepatitis B surface antigen negative, rubella immunity confirmed, syphilis test negative (Treponema test negative) and Ultrasound scan abnormal (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was also a case of drug exposure during pregnancy, third trimester.   Relevant laboratory test results included: Antibody test - On 03-Jan-2006: Negative Chlamydia test - On 03-Jan-2006: Negative Gene mutation identification test - On 03-Jan-2006: Cystic fibrosis (CF) gene mutation negative, on 02-Mar-2006: Genetic Screening - quad screen negative. HIV test - On 03-Jan-2006: nonreactive Hepatitis B surface antigen - On 03-Jan-2006: nonreactive Rubella antibody test - On 03-Jan-2006: confirmed Serology test - On 03-Jan-2006: AB positive (+) Treponema test - On 03-Jan-2006: Negative Ultrasound scan - On 02-Mar-2006: Ultrasound (abnormal) revealed bilateral choroid plexus cyst and echogenic focus]  It was reported that, at 29 weeks gestation, an episode of pre-term labor resolved with subcutaneous terbutaline.   Event outcome for Foetal disorder was reported as recovered at the time of reporting also for the other reported event outcome was not applicable.   Additionally, at time of reporting, the patient delivered a live female infant vaginally at 39 weeks gestation on 23 July 2006. The infant weighed 2360 grams and had no congenital anomalies. Apgar scores had been 8/9 at one and five minutes respectfully.  There had been no complications experienced during labor and delivery.  No additional information was provided.  Follow-up information was received on 19-Apr-2021, from the other health professional via health authority (under reference number: US-SA-SAC00000000342755 and vaccine adverse event reporting system periodic number: 336669).   Reporter, collection organization, pregnancy information, other relevant history, lab data and event updated in field.   Added event: antibody test negative, chlamydia test negative, human immunodeficiency virus (HIV) test negative, Hepatitis B surface antigen negative, rubella immunity confirmed, Treponema test negative and Ultrasound scan abnormal.; Sender's Comments: Follow-up information was received on 19-Apr-2021 changes the previous assessment of the case: This case involved  a 28 year old pregnant female patient who had foetal disorder and premature labour with with antibody test negative, chlamydia test negative, human immunodeficiency virus (HIV) test negative, Hepatitis B surface antigen negative, rubella immunity confirmed, Treponema test negative and Ultrasound scan abnormal. Time of onset was compatible with role of vaccine. The patient had a history of thalassaemia minor, two previous pregnancies (both had been live births with no congenital anomalies), body mass index (BMI) - 19.7 and no alcohol (ETOH), drugs or tobacco. Patient was treated with prenatal vitamins throughout pregnancy. Further information regarding previous vaccination and tolerance and laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.