Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Coombs indirect test negative, Culture urine negative, Depression, Drug exposure during pregnancy, Foetal disorder
Clinical narrative: Information has been received through the Merck pregnancy registry and from a physician concerning a 16-year-old female with no pertinent medical history or allergies, who on 09-FEB-1998 was vaccinated with a first dose of VARIVAX (Oka/Merck). On 05-OCT-2007 the patient was vaccinated subcutaneously with a second dose of 0.5 ml of VARIVAX (Oka/Merck) (658424/1181U). There was no concomitant medication. The patient had a negative pregnancy test on 05-Oct-2007, and a positive pregnancy test on 20-Nov-2007. Unspecified medical attention was sought. No other symptoms were noted. No product quality complaint was involved. Follow-up information has been received from the Merck pregnancy registry which indicated that the patient is a female with a history of 0 pregnancies and 0 live births whose last menstrual period was on 20-Sep-2007. Her estimated date of delivery is 16-Jun-2008. On 20-Nov-2007 she was prescribed pre-natal vitamins daily. Studies included: 30-Dec-2007 an ultrasound for dating purposes, 13-Dec-2007 a "first TM integrated section" which was normal and on 30-Jan-2008 serum alpha-fetoprotein test with the results pending. It was reported that there was no local reaction at the vaccination site, no varicella (chickenpox) symptoms post vaccination and no herpes zoster symptoms post vaccination. Follow-up information has been received from the Merck pregnancy registry concerning this 16-year-old female with a history of depression and adjustment disorder with meds and counseling in the past who on 05-Oct-2007 was vaccinated subcutaneously with a second dose of 0.5 ml of VARIVAX (Oka/Merck) (658424/1181U). It was noted that the patient had the following complications during pregnancy: chlamydia (05-OCT-2007 and 24-DEC-2007) and depression (date unspecified). The patient was treated with azithromycin 1 g, 1 dose taken (20-NOV-2007 and 24-DEC-2007) for chlamydia. The patient did not receive any medications for depression. The patient was also treated with clotrimazole 1 app. QHS, 7 doses taken (29-JAN-2008) for vaginal candidiasis. On the following dates the patient had ultrasounds performed: 03-DEC-2007 (12.0w CRL with EDC 16-JUN-2008, suggestive of significant bladder outlet obstruction), 13-DEC-2007 (13.4w, nl FM, nl cardiac activity, nl AFI, posterior placenta, nuchal translucency 1.7mm, nl fetal bladder, nl fetal renal pelvises, rec extended anatomic survey at 18-20 weeks) and 19-JAN-2008 (18.7w, nl anatomy, AFI 13.8 placenta posterior). On 22-JUN-2008, 40 plus weeks from LMP the patient gave birth to a 7 lb 3 oz normal male baby. The baby has a congenital anomaly of pyloric stenosis. There were no complications during labor and delivery. At the time of the report, the outcome of the baby was unknown. It was noted that there was no feature of congenital varicella zoster syndrome (cutaneous scars, limb hypoplasia, eye and CNS malformations, neurologic deficits) noted. The reporter considered pyloric stenosis to be a congenital anomaly. Additional information is not expected.