Age: 24.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Exposure during pregnancy, Foetal disorder
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 12-AUG-2008, a 24 year old female was vaccinated IM with the second dose of GARDASIL (lot #: 660557/0072X) into her left arm. Suspect therapy given subcutaneously into her left arm included the second dose of VARIVAX (Merck) (MSD) (lot #: 660087/0335X). It was reported that the client states she had an allergy to ibuprofen but no other medical conditions or birth defects. The reporter denied any illness at time of vaccination. There was no other medication. The patient was counseled for pregnancy. It was reported that the patient called on 21-MAY-2009 and stated she had been pregnant on 12-AUG-2008 and did not know it. The patient stated she had not missed period yet when she came in for vaccinations, so she did not think she was pregnant at the time. The patient delivered twin boys but her estimated delivery date was 13-APR-2009 (last menstrual period was 07-JUL-2008). Baby A weight was 5 pounds and 10 ounces at birth and baby B weight was 5 pounds and 7 ounces. Patient took baby A to pediatrician on 27-APR-2009 with what she thought was a respiratory illness. Doctor heard a murmur and upon further evaluation was admitted to hospital and flown to another hospital. The infant was diagnosed with total anomalous pulmonary venous return and had surgery on 29-APR-2009. The infant was discharged from the hospital on 04-MAY-2009 (WAES 0906USA02603B1, considered a congenital anomaly). Baby B was found to have an innocent heart murmur (WAES 0906USA02603B2). Patient also had a 5 years old son and 2 year old daughter who were healthy. The VAERS ID number are 346829 and 29704. Additional information was obtained on request by the Company from the FDA under the Freedom of Information Act. The patient was taking no additional information. The original reporting source was a county health department. Follow up information received on 20-JUL-2015. From MARRS# 1412USA011729. Information has been received from a published literature article. This retrospective pregnancy report refers to a female pregnant patient of unknown age. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, route, anatomical location, lot number and expiration date were not reported) and to Varicella Vaccine (manufacturer unknown) (dose, route, anatomical location, lot number and expiration date were not reported). A baby was born with total anomalous pulmonary venous return, the infant had surgery at 4 weeks of age to repair this defect. This review of VAERS reports comprising more than 6 years of monitoring found no safety concern among pregnant women or their infants who received this vaccine during pregnancy. Additional information has been received during a telephone on 28-JAN-2015. The receptionist answered the phone call and a message was left to the physician to return the phone call. Additionally, a request was made for patient identifiers, lot numbers and expiration date and dates of vaccination. All telephone attempts to obtain follow up information have been unsuccessful. This is one of several cases from the same literature (1412USA009575 and 1412USA011730). Additional information has been requested. It has been determined that case # 1412USA011729 is a duplicate of case # 0906USA02603. Therefore, case # 1412USA011729 is being deleted from our files and the cases consolidated into case # 0906USA02603.