Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan normal, Wrong drug administered
Clinical narrative: Information has been received from a registered pharmacist concerning a 23 year old female patient with penicillin allergy who on 04-DEC-2008 was vaccinated with the first dose of GARDASIL, lot # 661044/0548X. It was reported that the patient was 10 weeks pregnant when vaccinated with her first dose of HPV vaccine. It was reported that, "pregnancy is normal to date". EDD was 10-JUL-2009. The patient sought medical attention at the physician's office. Routine prenatal labs and ultrasound were scheduled. Follow up information has been received from a pharmacist for the pregnancy registry for GARDASIL, concerning a 23 year old female with penicillin allergy and obesity with a history of 1 pregnancy and 1 full term live birth with no birth defects or infant complications in previous pregnancies and a history of postpartum depression after first pregnancy, who on 04-DEC-2008 was vaccinated with a dose of GARDASIL (dose and route not provided) (lot number 661044/0548X). Concomitant therapy included prenatal vitamins (unspecified) for supplement. Routine lab test performed on 24-DEC-2008 included ultrasound with a result of singleton intra uterine pregnancy. Date of last menstrual period was reported as 03-OCT-2008, estimated conception date was reported as approximately 04-OCT-2008 and estimated delivery date was reported as 10-JUL-2009. Follow up information was received from the pharmacist. It was reported that the patient gave birth to a normal male infant with no congenital anomalies, weighing 9 pounds and 13.9 ounces (length 22 inches; head circumference 36.3cm) on 17-JUL-2009, at 40 5/7 weeks from LMP. The baby experience fetal macrosomia and reduced fetal movement but was a normal newborn (WAES 0812USA02810B1). During the pregnancy, the following complications were noted:  maternal obesity (contributing factor) and intermittent gross hematuria of unknown etiology. The following diagnostic tests were carried out:  On 12-JUN-2009, a renal ultrasound was performed which showed mild hydronephrosis of right kidney (possibly secondary to pregnancy). No renal stones were identified. The patient had a group B strep infection, which was treated with clindamycin after delivery. Other medication used during pregnancy included cyclobenzaprine (started on 04-FEB-2009) for the treatment of muscle spasm/shoulder strain, metronidazole (From 09-MAR-2009 to 16-MAR-2009, dose 500mg BID) for the treatment of bacterial vaginosis and sulfamethoxazole (+) trimethoprim (from 05-JUN-2009 to 09-JUN-2009, dose 800/160mg BID) for presumed UTI, culture negative. It was noted that after delivery the patient was referred to urology for further evaluation of hematuria (cytoscopy). Follow up information was received from a pharmacist concerning a 23 year old female patient with penicillin allergy who on 04-DEC-2008 was vaccinated into the left deltoid with the first dose of GARDASIL (lot number 661044/0548X). It was reported that the intended vaccine was influenza virus vaccine (unspecified). The patient delivered a live born infant on 17-JUL-2009 without problems. A routine pregnancy ultrasound was performed on 24-DEC-2008 (results not provided). It was noted that the patient received prenatal vitamins, sulfamethoxazole (+) trimethoprim, cyclobenzaprine and metronidazole during her pregnancy. No further information is available.