Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Breech delivery, Drug exposure during pregnancy, Foetal disorder, Laboratory test, Pain
Clinical narrative: Information has been received through the Merck pregnancy registry from a health professional and medical records concerning a 26 year old female with sulfonamide allergy who on 06-OCT-2006 was vaccinated with a first dose of GARDASIL.  On 21-DEC-2006, the patient was vaccinated with a second dose of GARDASIL.  Subsequently the patient became pregnant.  Last menstrual period was on 21-FEB-2007 and the estimated date of delivery was 28-NOV-2007.  Unspecified medical attention was sought.  The patient underwent "prenatal labs" (results not reported).  On 05-NOV-2007 a male infant was born (5 pounds 7 ounces, 17 1/2 inches long) (reported as pre-mature birth at 36 weeks).  The only complication was the infant was in the breech position.  The pregnancy included ZITHROMAX Z-PACK on 08-MAY-2007 for a sinus infection (4 days), KEFLEX on 21-AUG-2007 for a sinus infection (TID x 5 days) and TYLENOL #3 on 04-OCT-2007 for pain.  On 05-NOV-2007, the infant's total serum bilirubin test at 12 hours of life was 7.2.  At 24 hours of life it was reported as 7.3.  The infant was jaundice but was reported to be recovering.  It was reported in the physician's notes that the infant was at a high risk for rebound hyperbilirubinemia.  On 09-NOV-2007, the infant's total serum bilirubin was 13.1.  Instructions were given to the infant's mom that there would be no more bili checks but to call of the infant's appetite decreased.  On 14-NOV-2007 the infant had newborn screening tests done.  They were reported as normal.  On 19-NOV-2007, the infant's parents noticed a lump on the left side of the infant's neck.  The physician noted it was not tender or red.  It measured 1 to 2 cm and his range of motion was OK.  The physician assessed the lump as torticollis.  On 27-NOV-2007, the infant was seen by the physician and it was reported that he had an upper respiratory infection.  The mother was instructed to call if the infant had an increase in cough, difficulty breathing, emesis or if he was not eating.  On 29-NOV-2007, the infant experienced vomiting.  He had vomited phlegm 2 to 5 times and had had been congested for one day.  He did not have a cough.  The rest of the physician's assessment was normal.  On 05-DEC-2007, the infant was seen by the physician because he spits up phlegm after feeding.  This has been occurring for 1 week.  His assessment of the infant was a well child.  The torticollis was reported to be resolving.  On 13-DEC-2007, the infant's congestion and upper respiratory infection continued.  On 09-JAN-2008, the infant was diagnosed with conjunctivitis and was prescribed TOBREX.  On this day, the infant was also vaccinated with HIB, PEDIARIX, PREVNAR and Td.  On 14-JAN-2008, the infant experienced eye drainage, he was fussy, crying after feedings with a bloated stomach.  The physician's assessment was reported as upper respiratory infection and excessive gas.  On 28-JAN-2008, the infant was seen by the physician due to right ear drainage.  It was reported that 2 days ago the infant had trouble sleeping.  The physician noted moist white drainage from his right ear.  He prescribed amoxicillin 250 mg twice a day.  His assessment was otitis media.  On 02-FEB-2008, the infant experienced a skin rash on his buttock.  It was reported that there was breakdown but no infection.  The physician's impression was a diaper rash.  He instructed the infant's mother to continue zinc oxide and to keep the diaper dry.  On 27-FEB-2008, the infant experienced nasal congestion, occasional cough and he felt warm.  There was no home care except for TYLENOL every 4 hours.  On 07-MAR-2008, the infant's mother had a question about feeding.  It was reported that there was a family history of diabetes which was reported to be the center of attention.  On this day the infant received HIB, PEDIARIX, PREVNAR and rotavirus.  On 25-APR-2008, the patient had a follow up visit from the emergency room visit.  The mother had taken the infant to the ER for persistent diarrhea for 3 days.  He had been hydrated by mouth and vomited.  The physician's assessment was gastroenteritis.  At the time of this report, the infant's outcome was unknown.  Additional information has been requested.  All medical records available upon request.