Age: 24.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Drug exposure before pregnancy, Labour induction, Liver function test abnormal
Clinical narrative: Information has been received from a 25 year old female consumer, for VARIVAX (Merck), a Pregnancy Registry product, concerning herself who on 10-SEP-2009, was vaccinated with the first 0.5 ml dose of VARIVAX (Merck) (lot # not provided).  On the same day, the patient also received the first dose of MMR II.  On 14-OCT-2009, the patient received the second dose of VARIVAX (Merck) and the second dose of MMR II (lot # not provided).  By the end of December 2009, the patient found out that she was pregnant, with last menstrual period (LMP) 03-NOV-2009, estimated delivery date (EDD) 10-AUG-2010.  The patient had home pregnancy test performed.  At the time of reporting, the outcome was unknown.  The patient visited physician to seek medical attention.  Follow up information has been received from a registered nurse via medical records, concerning the 25 year old female patient with a history of 2 pregnancies and 1 abortion induced who on 10-SEP-2009 was vaccinated with the first dose of VARIVAX (Merck) and the first dose of MMR II.  On 14-OCT-2009 the patient was vaccinated with the second dose of VARIVAX (Merck) and the second dose of MMR II.  Concomitant therapy included vitamins (unspecified), PREVACID and ZOFRAN.  Subsequently, she became pregnant, her LMP was on 13-OCT-2009, EDD was on 20-JUL-2010.  The ultrasound performed on 21-JAN-2010 revealed the patient was 5 weeks and 6days pregnancy and the updated EDD was on 17-SEP-2010.  The initial exam on 25-JAN-2010 revealed the patient was 6 weeks pregnancy and updated EDD was on 20-SEP-2010.  On 30-MAR-2010 at night, the patient experienced one episode of forceful emesis, 1/4 cup of blood in emesis was noted.  2 weeks after on approximately 13-APR-2010 nausea and vomiting had resolved.  On 12-AUG-2010 the patient experienced rash on abdominal stria and inner thighs.  On 19-AUG-2010 the patient experienced pruritic rash.  BENADRYL and hydrocortisone didn't help.  On 27-AUG-2010 at gestation of 36 weeks, the patient delivered a normal, healthy female baby weighing 6 pounds 15 ounces.  There were no other complications or abnormalities.  Complication during pregnancy included elevated Liver function tests.  There was no complication during labor/delivery, no infections of illnesses during pregnancy.  A telephone call was placed to obtain the LMP and more information.  It was reported by the registered nurse that the LMP was 02-NOV-2009 and not 13-OCT-2009 as was previously reported.  The LMP was based on the patient's ultra sound.  The patient delivered at 36 weeks and had a 36 week induction.  The reason for the 36 week induction was that the patient had elevated liver testing (ALT 108 and AST 75).  The patient did recover from the elevated ALT and elevated AST.  Upon internal review, 36 week induction due to elevated liver testing (ALT 108 and AST 75) were considered to be other important medical events.  The baby's experience has been captured in WAES#1001USA01169B1.  Additional information is not expected.  This is an amended report, the serious criteria of 36 week induction due to elevated liver testing (ALT 108 and AST 75) were changed from non-serious to other important medical events.  All available medical records will be provided upon request.