Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pregnancy test positive, Rash, Smear cervix
Clinical narrative: Information has been received through the Merck pregnancy registry from a physician concerning a 15 year old female with anaemia and scabies infestation who on 23-MAR-2007 was vaccinated IM in the right deltoid with a 0.5 ml with a first dose of GARDASIL (lot# 654702/0011U) patient reported last menstrual period was 25-FEB-2007. On 23-MAY-2007 was vaccinated IM in the right deltoid with a 0.5 ml with a second dose of GARDASIL (LOT # 654702/0011U) patient reported LMP as 23-APR-2007. Concomitant therapy included Elimite cream. On 01-JUN-2007 the patient was seen in the office for a rash. When asked her LMP, she refused to answer. The patient had a positive pregnancy test and it was discovered that the patient was 24 - 26 weeks pregnant. Other laboratory tests included complete blood cell count, enzyme immunoassay HIV antibody screen, cervix Chlamydia trachomatis and Neisseria gonorrhoeae screen, and food allergy test (results not reported). Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/6/2007; 10/8/2007; 1/7/2008. Initial and follow-up information has been received through the Merck pregnancy registry from a physician and a registered nurse and medical records concerning a 15 year old female with anaemia, with no previous pregnancies, who on 23-MAR-2007, was vaccinated IM into the right deltoid with first 0.5 ml dose of GARDASIL (lot # 654702/0011U). The patient reported her last menstrual period was 25-FEB-2007. On 23-MAY-2007, she was vaccinated IM into the right deltoid with a second 0.5 ml dose of GARDASIL (lot # 654702/0011U). The patient reported her LMP was 23-APR-2007. On 01-JUN-2007 the patient was seen in the office for a scabies rash. The patient was treated with ELIMITE CREAM. When asked about her LMP, she refused to answer. The patient had a positive pregnancy test and it was discovered that the patient was 24 - 26 weeks pregnant. Other laboratory tests included complete blood cell count, enzyme immunoassay HIV antibody screen, cervix Chlamydle trachamatis and Neisseria gonorrhea screen, and food allergy test (results not reported). Her last menstrual period was 28-MAR-2007. Estimated date of delivery was 07-DEC-2007. Follow up information from an Outcome Pregnancy was 28-Mar-2007. Estimated date of delivery was 07-DEC-2007. Follow up information from an Outcome Pregnancy Questionnaire states that on 06-JUL-2007, the patient had a routine ultrasound at 10 weeks and 6 days. On 31-JUL-2007 the patient had preterm delivery at 34 1/7 weeks. The patient delivered a boy weighing 22.04 oz and he was 17.7 inches long. The apgar score was reported to be 8/9. The infant remained in the hospital for 1 week. No oxygen was required. Follow up information from medical records stated that on 14-AUG-2007, the infant came for his initial visit. His height was 19.5 inches and he weighed 5 lbs. 2 oz. It was reported that the infant's only problem at delivery was hyperbilirubinemia. The physician reported the infant as a well child and premaure at this visit. On 21-AUG-2007, the infant  weighed 5 lbs 12 oz and his height was reported as 19 inches. On 05-SEP-2007, the mother of the infant was reported to have started with mastitis on 24-AUG-2007 therefore she had stopped breast feeding th infant. The infant was taking formula and his weight was up 1 lb 10 oz from last visit. His height was 21.5 inches and his weight was 7 lbs 6 oz. On 10-OCT-2007, the infant came in for a check up. It was reported that he had been congested for 1 week. His weight was 10 lbs 2.5 oz and his height was 22.5 inches. The infant received PREVNAR, PEDIARIX, and ROTATEQ. The infant was also prescribed ACETAMINOPHEN. The physician reported the infant as a well child and alert and active. On 07-NOV-2007, the infant was again seen as follow up for his height and weight. His height was 24 inches and he weighed 11 lbs 13 oz. On 13-DEC-2007, the infant received PREVNAR, PEDIARIX, ROTATEQ and ACETAMINOPHEN. The infant was reported to be a well child. His height was 41.5 cm and his weight was 13.5 lbs and 3/4 oz. On JAN-2008 the infant was seen by the physician for a fever which he had for the past 2 days. He had emesis 4 times, had 6 loose stools with blood and mucus. He was seen in the emergency room 2 days ago. The mther was instructed to give him fluids. His lase emesis was at 6 am and he had 2 normal stools that day. His appetite was down and he was only taking 2 grams of "food." It was also reported on Monday he had urinary sympotoms. He was also reported tohave a cough. The physician's impression was otitis. He prescribed AMOXIL 125 mg TID, a stool culture and sensitivity. Pedialyte and to follow up on 04-FEB-2008. His height at that visit was 42.5 oz and his weight was 15 lbs 1 oz. The stool culture resulted in campylobacter jejuni/coli. On 05-FEB-2008, the patient still had loose and watery stools but there was no blood in the stood and no vomiting. The infant was reported as eating well and he was continuing on AMOXICILLIN. His weight was 15lbs 4oz. The physician's plan was to try lactose free formula during diarrhea illness. On 12-FEB-2008, the infant went for a check up. He was reorted to be doing much better and he was trying to roll over. He was taking formula 3 to 4 times  day and he started on cereal. His height was 44 cm and his weight was 15 lbs 7 1/4 oz. The physician's assessment was a well child. The infant finished course of "EES". He also received PREVNAR, PEDIARIX, FLU, ROTATEQ and ACETAMINOPHEN. On 17-MAR-2008, the patient was seen for a follow up height (not reported) and weight (15 lbs 13 oz). The infant is taking formula every 3 hurs and cereal three time a day. It was reported that the infant still had some congestion. In the past 5 weeks his weight had gone up 1 lb 6 oz and his height was unchanged. He also received a second dose of the flu vaccine. At the time of this report, the infant's outcome was unknown. Additional information is not expected. All medical records are availale upon request.