Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site irritation, Injection site rash, Laboratory test normal, Maternal exposure during pregnancy
Clinical narrative: Information has been received from a physician for VARIVAX (Merck), a Pregnancy Registry product, concerning a 26 year old female patient with none drug reactions or allergies reported with a history of 1 pregnancy (also reported as 1st pregnancy) and 0 live births who on 12-APR-2012, the patient was tested for varicella antibodies before vaccination with VZV containing vaccine. This test showed that the patient was not immune. On 19-APR-2012, the patient was vaccinated SC with 0.5 ml of a dose of VARIVAX (Merck) (lot number: 671026/0835AA). The patient was vaccinated at private MD office. Concomitant therapy included VALTREX. The physician (also reported as a nurse) reported that a patient was administered VARIVAX (Merck) and she was pregnant. On an unspecified date, urine pregnancy test and ultrasound were performed (results not provided). It was reported that LMP was on 04-NOV-2011 and EDD would be on 10-AUG-2012. No treatment was given for the treatment of the adverse event. Follow-up information has been received from a physician via pregnancy questionnaire indicated that the female patient with no previous pregnancies and no previous live births who on 19-APR-2012 was vaccinated with a 0.5 ml dose of VARIVAX (Merck) (lot number: 0466AA, previously reported as 671026/0835AA). Concomitant therapies included: ZOFRAN and PNV. On 22-FEB-2012, an ultrasound was performed results within normal limits 10 weeks fetal "Survey". Follow-up information has been received from a physician via pregnancy questionnaire and prenatal medical record indicated that the female patient with 1 previous pregnancy and no previous live birth, a history of surgery of wisdom teeth, hypoglycemic and anemic, no known drug allergies, no other medical history, or condition herself/family who in the fall of 2011 was vaccinated with a dose of flu shot. On 12-APR-2012 she was vaccinated with a dose of Tdap (lot # not reported). On 12-APR-2012, patient was tested for varicella antibodies and result showed not immune. On 13-APR-2012 the patient developed local irritation and rash (red). On 19-APR-2012 she was vaccinated with a 0.5 ml dose of VARIVAX (Merck) (lot # 671026/0835AA). On 10-DEC-2011 pregnancy test was positive. LMP was on 04-NOV-2011 and EDD would be on 10-AUG-2012. It was planned pregnancy. The patient had birth control with ORTHO TRI-CYCLEN in past year which was stopped in July 2011. During pregnancy, she was no problems except moderate nausea and vomiting 5 times a week. No treatment for nausea or vomiting. She was now using OTC prenatal vitamins and tolerated them. Ultrasound was performed on 08-FEB-2012 and 22-MAR-2012 showed 14.1 and 19.6 weeks of gestation. All prenatal and physical examinations performed were within normal limits. Follow-up information has been received from a registered nurse indicating that the patient did receive the flu shot, but the patient hadn't been vaccinated in their office, so she did not know the exact date, which flu vaccine the patient received, or the lot number. She was also unaware of where the patient was vaccinated. Follow-up information has been received from a licensed practical nurse concerning the female patient, who on 31-JUL-12 at 38 weeks and 4 days of gestation delivered a female infant weighing 3231.18 gms or 7 lbs 2 ozs via vaginal delivery. The infant's APGAR scores are not available. Upon delivery, the infant was noted to be a normal, healthy newborn. The patient was also placed on OMEGA-3. It was reported that the patient had an urinary tract infection (UTI) during pregnancy (approximately in March 2012). UTI was treated with MACROBID 200mg for 14 days. It was also reported that, on approximately 04-JUL-2012 ("at 37.3 weeks") the patient experienced elevated blood pressure. It was reported that, on 31-JUL-2012 (during delivery) the patient had episiotomy and second stage laceration. Laboratory tests were reported as "normal,  routine pregnancy labs" included Group B Streptococcus test, Blood glucose test, Hepatitis B test, Pregnancy-induced Hypertension Test (PIH) and some unspecified "labs" (dates and results unknown). At the time of the report, the patient's outcome for elevated blood pressure, UTI, episiotomy and second stage laceration was unknown. Additional information is not expected.