Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Alpha 1 foetoprotein normal, Condition aggravated, Ear infection, Ear tube insertion, Exposure during pregnancy
Clinical narrative: Information has been received from a Licensed Practical Nurse (L.P.N.), for GARDASIL, a Pregnancy Registry product, concerning a 22 year old female with concurrent condition of asthma, drug reactions or allergies to CECLOR and with a medical history of depression and frequent Urinary tract infection (UTIS) who was vaccinated with the first and second GARDASIL (Lot # 667165/1167Z, expiration date 08-DEC-2011) on 02-MAR-2011 and 03-MAY-2011, respectively. Concomitant therapy included albuterol. The nurse reported that the patient was given the second dose of GARDASIL while she was potentially pregnant. On an unspecified date, the pregnancy test showed positive. The last menstrual period was 24-MAY-2011 and the estimated delivery date was 28-FEB-2012. No adverse reactions reported. The patient called office on 20-Jun-2011 to seek medical attention. Follow-up information was received from a physician concerning a 22 year old female who was vaccinated with GARDASIL. The patient had once previous pregnancy and once full term delivery 38 weeks and 3 days after LMP. The patient did not have any pre-term deliveries, spontaneous abortions, elective terminations and fetal deaths. The birth defects did not occur in any previous pregnancies. Follow up information has been received from a physician via pregnancy questionnaire concerning the patient with anxiety depression (weaned off citalopram at 4 weeks gestation, from 24-MAR-2011 to 24-JUN-2011 10 mg daily), a history of recurrent ear infections with fluid in ear, a history of hemorrhage postpartum (PP) and a family history that her husband's cousin's daughter with Angelman's Syndrome. Concomitant therapy included prenatal vitamins during all pregnancy. On an unknown date the patient experienced recurrent ear infections, fluid in ears and tubes in ear was placed by ear, nose and throat (ENT) on 22-AUG-2011. First trimester screen on 11-AUG-2011 was with normal limits. On 19-SEP-2011, serum alpha-fetoprotein test (AFP) was negative for neural tube defects and all OB lab work with pap were with normal limits. On 09-FEB-2012 at 37 3/7 weeks from LMP, the patient delivered a male baby with weight reported as 6 # 1, length of 19.5 inch and Apgar score of 8 and 9. The infant was normal (no congenital anomalies and no other complications or abnormalities). There was no complications during pregnancy or labor/delivery. At the time of reporting, the outcomes of recurrent ear infections and fluid in ears were unknown. Follow-up information has been received from the physician concerning a 22 year old female patient with a history of one full term previous pregnancy (delivered at 38 and 3/8 weeks of gestation), no history of preterm births, anomalies, fetal deaths or abortion. It was noted that the patient got pregnant in less than sixty days after immunization with GARDASIL. It was reported, that on 08-FEB-2012 (previously reported 09-FEB-2012), the patient delivered a baby. Lab test included ultrasound (date unspecified) showing pregnancy. Additional information is not expected. 18APR2013 - This is a corrected report. A code for "Ear Tube Insertion" (previously mentioned in the narrative), has not been added to the report.