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Write-up: Information has been received from a licensed visiting nurse (L.V.N.) concerning an 18 year old, female with no pertinent medical history and no drug reactions or allergies who on 27-SEP-2006 was vaccinated into the left deltoid with the first dose of 0.5 mL dose of GARDASIL, (Lot # 653736/0868F). There was no concomitant medication. On 13-DEC-2006, the patient was vaccinated into the left deltoid with the second 0.5 dose of GARDASIL, (Lot # 653736/0868F). The patient sought unspecified medical attention. The nurse reported that the patient presented to the pregnancy crisis center in January 2007 and a urine pregnancy test was performed, and the result was positive for pregnancy. It was reported that the patient presented to the physician''s office on 12-FEB-2007, and another urine pregnancy test was taken and the result was positive for pregnancy. In follow-up received from a physician concerning an 18 year old, white, female with no pertinent medical history and no drug reactions or allergies who 27-SEP-2006 was vaccinated into the left deltoid with the first 0.5 mL dose of GARDASIL, (Lot # 654540/0800F). On 13-DEC-2006, the patient was vaccinated into the left deltoid with the second 0.5 mL dose of GARDASIL, (Lot # 653736/0868F). The patient had a maternal serum alphafetoprotein test (screen) on 23-APR-2007 with the result of negative. The patient had an ultrasound (screen) on 24-FEB-2007 with results of normal limits ("nl") and an ultrasound (screen) on 26-APR-2007 with results of "nl". It was reported that the patient had a liveborn, normal, male infant on 17-SEP-2007 with no congenital anomalies and no complications or abnormalities. The infant''s weight was 7 pounds and 12.4 ounces, 20 inches in length, Apgar score 9/9, weeks from last menstrual period (LMP) 39 2/7 weeks, head circumference 13 inches. It was reported that the patient had bacterial vaginitis on approximately, 12-JUN-2007 and was treated for 7 days with FLAGYL, 500 mg, twice a day. On 24-JUL-2007, the patient was treated for a headache with DARVOCT-N 100, every 6 hours. The patient had anemia on 07-AUG-2007, and was treated with "tandem fe", (iron unspecified) every day. The patient was vaccinated with rubella virus vaccine (manufacturer unknown) one dose, on 19-SEP-2007 for prevention. It was reported that the estimated conception date was December 2006 or early January 2007. The patient did not have previous pregnancies, full term deliveries, pre-term deliveries, spontaneous abortions or miscarriages, elective terminations or fetal deaths. Additional information has been requested. Follow up information in the form of medical records from a neurology exam, performed on 11-MAR-2008 were received (aged 5 1/2 months). The neurolgoist documented that the infant had a history "notable for an interval ear infection, as well as RSV bronchiolitis. The infant was reported to be "well appearing child," with regular heart sounds. The neurologic exam indicated "he has diffuse low tone. Does bring his hands to midline, but is not yet rolling over. He has relatively good head control his reflexes are brisk and sysmetric. He moves all extremities sysmetrically. He smiles, he tracks. "The neurologist''s impression was "lesion-related epilepsy secondary to bilateral schirencephaly with evidence of mild motor delay and tone abnormalities (referred to new-onset seizures in January). Therapy continued with TRILEPTAL, no breakthrough seizures since discharge with referral for Early Childhood Intervention and genetics for family counseling, follow up in 3 months. Follow up information received from the mother''s OB/GYN indicated the office did not notice any abnormalities before the baby was born. However, the baby started presenting with some abnormalities after he was born. His head was larger than it was supposed to be. Additional information is not expected. All available medical records will be provided upon request.
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