Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Foetal disorder, Ultrasound scan
Clinical narrative: Information has been received through Merck pregnancy registry from a nurse midwife concerning an underweight 20 year old female with a history of LGSIL, biopsy, colposcopy, and 1 previous pregnancy with an elective termination, who on 27-JUN-2007 was vaccinated with the first dose of GARDASIL. Concomitant therapy included 150 mg DEPO-PROVERA, and prenatal vitamins 200 mg. It was reported that the patient was found to be pregnant and at the time of reporting the patient was about 14 weeks pregnant (last menstrual period was approximately 15-MAY-2007 and her estimated delivery date was 20-FEB-2008. Unknown medical attention was sought. No product quality complaint was involved. Follow-up information was received from a certified nurse midwife and from pediatric medical records indicating that on 19-FEB-2008, at 39 weeks and 6 days the patient delivered a 6 pound 7 ounce female infant with an apgar score of 9/9. The infant was reported to be normal with no congenital anomalies and no complications. It was reported that a neonatal prenatal ultrasound showed in utero hydrocephalus. Both lateral ventricles were dilated and there was some dilation in the third ventricle. A late repeat ultrasound (on 14-NOV-2007 and 27-DEC-2007) showed resolution. Additional information has been received from a physician via pediatric medical record concerning a 10 week old female. On 05-MAR-2008 the patient was seen at the office for her 2 week visit. It was reported that the child's growth and development were normal. On 28-APR-2008 the patient was seen at the office for her 2 month visit. It was reported that the child was well, with normal growth and development. The patient presented to the office with a dysconjugate gaze in which the patient's pupil's were not responding, and the patient could not "track." Inutero hydrocephalus was seen on an ultrasound. A late ultrasound showed resolution, therefore a repeat ultrasound was scheduled. The patient was referred to another physician to be examined. The patient was instructed to follow-up for next well exam in 2 months. On 28-APR-2008 the patient was vaccinated with a dose of ROTATEQ, a first dose of PREVNAR, (unspecified carrier), DTaP, Hib (unspecified carrier), HEP B (manufacturer unknown), and poliovirus vaccine. On 01-MAY-2008 a neonatal prenatal ultrasound was performed due to the previous finding of inutero hydrocephalus. Both lateral ventricles were relatively dilated and some dilation was seen on the third ventricle. On 13-MAY-2008 laboratory diagnostics were performed and the results are located in the laboratory section. On 21-MAY-2008 a brain MRI without contrast was performed due to possible hydrocephalus and increased cranial size. The evaluation showed some slight prominence of the lateral ventricles, and some mild prominence of the subarachnoid space. The features were possibly representative of some benign enlargement of the subarachnoid space. A retroperitoneal ultrasound was performed on 30-MAY-2008 due to hydronephrosis and to rule out a neuroblastoma. No intrarenal masses were identified and there was no evidence of renal mass or renal obstruction. The patient was also examined on 30-MAY-2008. On the exam there was some opsoclonus with a question of tiny seizure activity. The findings showed some roving of eyes. It was briefly questioned if the patient was seeing hands move across her face. The patient did not respond to loud noise, and sunsetting was present. The patient experienced some non-specific twitches of ext/head, but at times appeared to recognize/interact despite continued eye movements. The patient's dysconjugate gaze was going to be further evaluated, and an ultrasound of the adrenals and an EEG of the head and evoked response testing were scheduled. On 26-JUN-2008 the patient was seen at the office for her four month visit. At that time the patient was vaccinated with DTAP, (unspecified), poliovirus vaccine, PREVNAR, and HIB (unspecified carrier). It was reported that the patient's eyes were not moving together and that the right eye darts off at times. An EEG was done and was normal. On 22-AUG-2008 the patient was seen at the office and presented with swelling on the soft spot that was just noticed the day before. The patient had no change in behavior, no vomiting, and was feeding well. The patient had optic atrophy with irodenesis (suggested little or no macular development. The patient's tone and head control were excellent. The patient tracked and opticokinetic strip and it induced lateral gaze nystagmus. The patient picked up objects and brought them closer to her eyes and was clearly using vision as a primary sensory input. The idirodenesis was striking and she has not had an endocrine consult for pituitary insufficiency. On 27-AUG-2008 the patient was seen at the office for her 6 month visit. The patient was vaccinated with PREVNAR, pertussis vaccine (unspecified), and HEP B (unspecified) (manufacturer unknown). A repeat ultrasound was scheduled. It was reported that the patient's lateral nystagmus persisted. There was some bulging fontanelle on an exam a week prior, which resolved with sitting up. The patient's follow-up shots were ordered for 3 months. The patient seemed to track, however does not reach for things or have object permenance. The patient experienced lateral nystagmus with no pupillary constriction to light on exam. The patient was referred to the hospital for an ophthalmology consult in order to get a visual evoked response test and an electro-retinalgram. At the time of the report, the outcome of the patient was unknown. Hydrocephalus was considered to be a congenital anomaly. Information received on 05-SEP-2008 contained the following adverse experiences: thrush (05-MAR-2008), and diaper dermatitis (05-MAR-2008). The patient was prescribed nystatin ointment applied topically three times a day as needed, and nystatin oral solution 1 mL by mouth every 4 to 6 hours for 10 days. The patient also experienced colic (05-MAR-2008), and constipation (05-MAR-2008). The constipation was treated with 1 teaspoonful of karosyrup 1 to 4 times a day. Pediatric medical records were received and reviewed; no adverse experiences related to the prenatal exposure were identified, however, an experience related to ROTATEQ was identified, and is described in WAES report # 0809USA02030. Additional information has been requested.