Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Gestational diabetes, Nausea, Normal newborn, Placenta praevia, Simplex virus test positive
Clinical narrative: Information has been received from a 27 year old female consumer, for VARIVAX (Merck), a Pregnancy Registry Product, concerning herself with no pertinent medical history and no drug reactions/allergies who on 16-AUG-2010 was vaccinated with a dose of VARIVAX (Merck) (LOT# not reported) in the practice, while 14 weeks pregnant (as of 16-AUG-2010). There was no concomitant medication. There were no lab diagnostic studies performed. The patient sought medical attention via telephone call to nurse practitioner. No adverse effect was reported. The LMP is approximately 10-MAY-2010; the EED is approximately 14-FEB-2011. Follow up information has been received from a physician, via medical records, concerning the 27 year old female married patient with seasonal allergy, no previous pregnancy, family history of myocardial infarction and diabetes, and a history of herpes simplex, infertility (treated with CLOMID and papanicolaou smear abnormal. On 30-JUN-2010 the patient felt some nausea but no vomiting. Patient took prenatal vitamins (PNV) and complained of constipation. No cramping and no bleeding. Patient was advised to try COLACE 100 mg bid or increase fiber in diet. Nutrition was discontinued. On 15-JUL-2010: During unscheduled obstetric visit, patient complained of vesicle lesions noted which was swabbed. On 22-JUL-2010, Herpes simplex virus (HSV) culture was back and positive for HSV-2. The physician spoke to patient regarding these results. This was a primary outbreak for her. She just picked up her therapy for VALTREX for which she would take 1 oral bid for 10 days. The physician informed the patient that after she was done with current therapy then she would need to take VALTREX 500mg oral qd for the remainder of her pregnancy. On 28-JUL-2010, the patient had some nausea. No cramping and venous bleeding. Patient also had prenatal vitamins (PNV); Herpes simplex virus (HSV) was reviewed again. Patient took VALTREX twice daily. On 16-AUG-2010, patient given a dose of VARIVAX (Merck) instead of the titer done at primary care physician office. Patient was very upset. On 16-AUG-2010 varicella titer IgG: 1.34 (imm), IgM: 0.12 (-). On 23-AUG-2010 varicella titer IgG: 2.49. On 25-AUG-2010, the patient felt ok. No cramping and no venous bleeding. Patient also had prenatal vitamins (PNV); Patient took VALTREX daily. On 30-AUG-2010, there was a telephone call from the patient. Patient complained of a constant suprapubic pain for the last hour since she had a bowel movement (BM). Patient denied any constipation and had been having BM daily. Patient denied any pain with urination, any injury to area and bleeding. The physician recommended the patient to increase fluids, take TYLENOL for discomfort, try drinking some warm fluids and take warm bath. On 20-SEP-2010, the physician advised the patient to push fluids and lay around. On 24-SEP-2010, ultrasound revealed complete previa and no anomalies. On 29-SEP-2010, the patient felt good. Patient was still dealing with constipation and taking VALTREX daily and COLACE. On 27-OCT-2010, the patient had back pain and hip pain which just started on 25-OCT-2010. The patient's LMP was 09-MAY-2010, estimated delivery date is on 16-FEB-2011. Follow up information has been received from a completed questionnaire from a certified nurse midwife (CNM) concerning the patient with no previous pregnancy who took VALTREX, 500 mg, from August 2010 to present for the treatment of herpes simplex virus (HSV). The patient's LMP was on 10-MAY-2010 (previous reported as 09-MAY-2010), EDD was on 14-FEB-2011 (previous reported as 16-FEB-2011). On 24-SEP-2010 ultrasound performed for fetal survey revealed complete previa and no anomalies seen. As of 29-SEP-2010, the patient did not experience local reaction at vaccination site, varicella symptoms post vaccination or herpes zoster symptoms post vaccination. On an unspecified date, the patient experienced gestational diabetes. On 06-FEB-2011, the patient delivered a normal female baby. The baby's weight was "8-4". No further information is available. All available medical records will be provided upon request.