Age: 23.0
Sex: F
Vaccine: HEP, HEPA, IPV, MMR, TDAP, VARCEL
Symptoms: Back pain, Caesarean section, Dizziness, Drug exposure during pregnancy, Foetal disorder
Clinical narrative: Information has been received from a registered nurse, for VARIVAX (Merck), a Pregnancy Registry product, concerning a 23 year old female patient who on 20-OCT-2009 was vaccinated with a first dose of VARIVAX (Merck) (lot# not reported), a dose of MMR II (MSD) (lot# not reported), a dose of hepatitis A virus vaccine (unspecified) (lot# not reported), a dose of hepatitis B virus vaccine (unspecified) (lot# not reported), Tdap (lot# not reported) and poliovirus vaccine (lot# not reported). On 02-DEC-2009 the patient was vaccinated with a second dose of VARIVAX (Merck) (lot# not reported), a dose of hepatitis A virus vaccine (unspecified) (lot# not reported) and a dose of hepatitis B virus vaccine (unspecified) (lot# not reported) when she was pregnant. No adverse reactions were reported. Unspecified medical attention was sought via office visit. The patient's LMP was 20-OCT-2009 and her estimated delivery date is 27-JUL-2010. Follow up information has been received from a physician via medical records concerning the female patient gravida 1 para 0 with an EDC of 23-AUG-2010 (previously reported as 27-JUL-2010) based on LMP and consistent with an early first trimester ultrasound who on 20-OCT-2009 was vaccinated subcutaneously with a first dose of VARIVAX (Merck) (lot# 664935/0928Y) into the right, a dose of MMR II (MSD) (lot# 663991/0564Y) SC into the left, a dose of hepatitis A virus vaccine (unspecified) (lot# AHABB167DA-NONVFC) via IM route, a dose of hepatitis B virus vaccine (unspecified) (lot# AHABB167DA-NONVFC) via IM route, DTAP (lot# C3249AA) and poliovirus vaccine (lot# B0476-3). On 02-DEC-2009 the patient was vaccinated with a second dose of VARIVAX (Merck) (lot# 665087/0999Y) SC into the left, a dose of hepatitis A virus vaccine (unspecified) (lot# AHABB167DA-NONVFC) and a dose of hepatitis B virus vaccine (unspecified) (lot# AHABB167DA-NONFVC). Concomitant therapy included prenatal vitamins. The patient found out that she was pregnant after injections were given. On 31-DEC-2009, the patient experienced nausea. On 08-JAN-2010, the patient had spotting times 2 days (approximately 06-Jan-2010) and no cramping. On exam there was no blood in the vault, cervix closed. On 01-FEB-2010, the patient has had no further spotting, having occasional cramping, nausea and vomiting. Patient taking vitamin B6. On 23-MAR-2010, the patient complained of hemorrhoids and was taking stool softeners and OTC medication witch hazel (TUCKS) pads for them and they were helping. The patient denied constipation. Her acne cleared. On 11-MAY-2010, trace lower extremity edema was noted. On 20-MAY-2010, the patient developed hands numb and tingling. Discussed swelling with pregnancy. On 11-JUN-2010, hemorrhoids doing better after suppository. On 29-JUN-2010, the patient developed low back pain and dizziness one to days ago (approximately 27-JUN-2010) which lasted for 2 minutes. Patient was encouraged to increase fluids. On 13-JUL-2010, patient complained of intermittent uterine contractions not regular, cervix closed. On 03-AUG-2010, fetus in breech presentation, reported that patient will have a cesarean section around EDC if undelivered and breech. On 08-AUG-2010, the patient presented in labor and the fetus was in the frank breech position confirmed by ultrasound. After careful discussion of all risks and benefits, she agreed to proceed with surgery. On 08-AUG-2010 at 09:07 live baby girl was delivered by cesarean section under spinal plus local. The apgar scores were 8 and 9, weight was 6 pounds 7.6 ounces. There were no complications. Postoperative diagnoses were 1. Intrauterine pregnancy at 37 weeks and 6 days gestation; 2. persistent uterine contractions indicative of early labor; 3. Frank breech presentation. Upon internal review frank breech presentation which lead to a cesarean section was considered to be an other important medical event. Additional information has been requested. All available medical records will be available upon request.