Age: 29.0
Sex: F
Vaccine: RAB
Symptoms: Abdominal pain upper, Abortion spontaneous, Exposure during pregnancy, Foetal heart rate abnormal, Muscle spasms
Clinical narrative: Initial report received on 26 MARCH 2013 (pregnancy report) from an investigator. A 29-year-old female subject had pregnancy. The subject had received third dose of IMOVAX on 07 MARCH 2013. (Batch number, route and site of administration not reported). The subject had received first dose IMOVAX on 07 FEBRUARY 2013. The subject had received second dose of IMOVAX on 15 FEBRUARY 2013. The current pregnancy history including risk factors (e.g. alcohol, tobacco or recreational drugs) was not reported. She had last menstrual period on 26 FEBRUARY 2013. The mother's and father's health status was not reported. The father's age was 27 years at time of report. The subject had 2 previous pregnancies. The subject had 1 live birth without congenital abnormality. The subject had 1 spontaneous abortion prior to 20 weeks gestation due to Miscarriage. The subject had no live birth with congenital abnormality, pre-term birth, elective abortion and fetal death (> 20 weeks gestation). She had not taken treatment for infertility. The subject had no family history or congenital abnormalities. She had maternal drug exposure of Phenergan unknown dose for stomach ache on 10 MARCH 2013. The subject had no relevant non serious adverse event. The details of pregnancy complication were not reported. The prenatal 1 testing (includes amniocentesis, alpha foetal protein, serologies, ultrasound, genetic screening an any other tests) was not reported. The pregnancy was ongoing at the time of the report. Her estimated date of delivery was not reported. List of documents held by sender: none. Follow up information received on 08 MAY 2013 and 14 MAY 2013. The mother had no health problems. The father was healthy and no illness was reported. The subject had no other comments of past obstetric information. The subject stated that the first ultrasound was not performed and the conception date was unknown. Due to miscarriage she did not get any expected due date.  The current pregnancy history including risk factors (e.g. alcohol, tobacco or recreational drugs) reported that the subject denied use of any alcohol, tobacco or recreational drugs. The subject had pregnancy complications. She had severe cramping on 15 APRIL 2013, hence she went to doctor and found out that she had a miscarriage on 15 APRIL 2013. Follow up information received on 21 MAY 2013. The subject did not have prenatal testing.  Follow-up information received on 03 JUNE 2013. It was confirmed that the pregnancy complication of miscarriage was a non-serious event. Follow up information (initial SAE report) received on 11 JUNE 2013 and 12 JUNE 2013 (SAE report). A 29-year-old female subject had miscarriage on 15 APRIL 2013 i.e. 39 days after receiving third intramuscular dose of IMOVAX in the left deltoid on 07 MARCH 2013 (batch number not reported). The subject received first dose IMOVAX on 07 FEBRUARY 2013, and second dose of IMOVAX on 15 FEBRUARY 2013. The subject had no medical history. The subject had no concomitant therapies. The subject had severe cramping on 15 APRIL 2013. She went to the doctor on 15 APRIL 2013. Ultrasound was performed. No other tests were performed. No fetal heartbeat was found. She had spontaneous abortion. The corrective treatment details included that the subject stated that she had no treatment or procedures for miscarriage. The event of miscarriage along with the associated symptom of severe cramping was resolved on 15 APRIL 2013. The event of miscarriage was not related to the study vaccine or to the trial procedure. The serious adverse event did not lead to the termination of the patient from the study. List of documents held by sender: none. Unblinding information received on 03 OCTOBER 2013. The subject received IMOVAX as 3rd dose of study vaccine. Code broken date was 26 SEPTEMBER 2013.