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Life Threatening? No
Write-up: This is in follow-up to report(s) previously submitted on 1/16/2007. Initial and follow-up information has been received from a physician through the Merck pregnancy registry concerning a 17 year old female with episodic reflux and dyspepsia and no known drug allergies and no previous pregnancies who on 16-Oct-2006 was vaccinated intramuscularly with the first dose of GARDASIL (0.5 ml) (lot # 653735/0688F). Concomitant therapy included PRILOSEC OTC and prenatal vitamins. From 20-Oct-2006 to 26-Oct-2006 the patient was placed on therapy with FLAGYL 500 mg twice daily for bacterial vaginitis. On 31-Oct-2006 the patient was found to have a positive pregnancy test. LMP was 11-Sep-2006. Unspecified medical attention was sought and the patient was placed on prenatal vitamins. On 19-Dec-2006, an ultrasound revealed gestational age 24.7 weeks which was not consistent with the estimated date of last menstrual period (LMP). On an unspecified date a Cystic Fibrosis carrier screen was performed, results were negative. On 22-MAR-2007 she delivered a normal, healthy male baby weighing 6 pounds 3 ounces and 18 1/2" long, with a head circumference of 33.5 cm, and APGAR scores of 9 at one and five minutes. The patient''s labor and delivery was uncomplicated. No other symptoms were noted. At the time of this report, the outcome of the events was unknown. Additional information has been requested.
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