Age: 35.0
Sex: F
Vaccine: RAB
Symptoms: Maternal exposure before pregnancy, Prenatal screening test, Ultrasound scan normal
Clinical narrative: Initial report received on 23 JULY 2013 (pregnancy report) and follow-up information on 31 JULY 2013 from an investigator participating in the above mentioned study. A 35-year-old female subject had vaccine exposure before pregnancy. The subject had received third dose of the study vaccine IMOVAX on 04 MARCH 2013. (Batch number, route and site of administration not reported). The subject had received first dose of IMOVAX on 07 FEBRUARY 2013. The subject had received second dose of IMOVAX on 14 FEBRUARY 2013.  The mother had mild depression and anxiety (non-medicated), migraines 1-2x/month. The father health status was reported as healthy. The current pregnancy history including risk  factors (e.g. alcohol, tobacco or recreational drugs) was not reported. The father's age was 33 years at the time of report. She had last menstrual period on 31 MARCH 2013. The details of meternal drug exposure were not reported. The subject hd 9 previous pregnancies with 3 live birth and no congenital abnormalities. The subject had no live birth with congenital abnormalities, no pre-term birth, no elective abortion and no spontaneous abortion(s) prior to 20 weeks gestation. The subject had 6 fetal deaths (>20 weeks gestation). She had not taken treatment for infertility. The subject had no  family history of congenital abnormalities. The details of relevant non serious adverse event were not reported. The details of pregnancy complication were not reported.The prenatal testing (including amniocentesis, alpha foetal protein, serologies, ultrasound, genetic screening and any other tests) was not reported. The pregnancy was ongoing at the time of the report. Her estimated date of delivery was 05 JANUARY 2014. List of documents held by sender: none. Follow-up information received on 08 SEPTEMBER 2013.  IT was confirmed that the subject had regular menstrual cycle. The date of conception was reported by the subject. IT was confirmed that the investigator was still following this pregnancy. It was unknown if the subject had experienced any relevant adverse event, whether she had pregnancy complications, prenatal testing were unknown. An attempt to contact the mother was made without success. The investigator will update once information is obtained. Follow up information received on 01 OCTOBER 2013. The subject saw the doctor on 13 AUGUST 2013 and the subject and baby had no abnormal findings. She had no drug exposure during pregnancy. The subject had no pregnancy complications. She did not experience any relevant non serious  adverse event. This would be the subject's 4th child. Her expected delivery date was 05 JANUARY 2014. Ultrasound was performed on 13 AUGUST 2013 and results were normal. Un blinding information received on 30 OCTOBER 2013. The subject received IMOVA as 2nd dose of study vaccine. Code broken date was 26 SEPTEMBER 2013. Follow up information received on 13 FEBRUARY 2014. The outcome of the pregnancy was reported as single live male fetus delivered on 30 DECEMGER 2013 with no non-serious complications of delivery/labor. The details of child included: Apgar score not reported, delivery mode: vaginal, weeks of gestation: 39, height: 52 cm, weight: 3.85 Kg and with no congenital abnormality. Follow up information received on 18 FEBRUARY 2014. The Apgar score was reported as 1 minutes as 9 and 5 minutes as 9.