Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, HEPA, HPV4
Symptoms: Pain in extremity, Peripheral coldness, Syncope, Ultrasound abdomen normal, Ultrasound pelvis normal
Clinical narrative: Initial information has been received from a consumer concerning her 13 year old daughter who in May 2007 was vaccinated with the first dose of GARDASIL (lot # 655618/0186U) along with HAVRIX. Then about four months after the first dose in approximately September 2007 she experienced abdominal pain and soreness in the arm. Then On 24-JUN-2008, the patient was vaccinated with the second dose of GARDASIL (lot # 660555/0279X) along with HAVRIX and about four months after receiving the second dose in approximately October 2008 the patient collapsed on the basketball court with abdominal pain and chest pain which kept on getting worse. Then she received her third dose of GARDASIL (lot # 661044/0548X) along with MENGITIS (manufacturer unspecified) and HAVRIX and was experiencing abdominal pain, low blood pressure, high heart rate, legs feet and stomach felt like they were burning, but were cold to the touch and she had seizure like symptoms, fatigue and throwing up bile. The consumer reported that the patient has been in hospital from October, 2008 till March, 2009, went to the emergency room 8 times and was in the hospital for 25 days. The consumer also reported that after receiving the third dose of GARDASIL the patient had her gall bladder removed and was hospitalized for four days. Consumer reported that the patient has had many test done, which came back negative, and she was still experiencing abdominal pains. No further AE information provided. The consumer had completed the online document on the MERCK VAERS website. She provided reference # E28764. Follow up information has been received from a physician concerning the 13 year old female patient with a history of attention deficit disorder who on 24-MAY-2007 was vaccinated with the first dose of GARDASIL (lot # 655618/0186U) and concomitantly received the first dose of HAVRIX (lot # 0001U) (previously reported as Hep A). On 24-JUN-2008, the patient was vaccinated with the second dose of GARDASIL (lot # 660555/0279X) and concomitantly received the second dose of HAVRIX (lot # AHVB26CC) (previously reported as Hep A). On 30-SEP-2008, the patient was vaccinated with the third dose of GARDASIL (lot # 661044/0548X) and concomitantly received MENACTRA (lot # U2688AA) (previously reported as MENGITIS and Hep A). The physician stated that the patient was seen in the office on 03-OCT-2007 with complaints of sharp abdominal pain and was diagnosed with MITTLESCHMERTZ. The patient was seen by the physician on 10-JUN-2008 with complaints of stomach pain, chronic abdominal pain and headaches. The patient was placed on therapy with FOCALIN XR. The patient had a pelvic ultrasound which was normal. On 20-JUN-2008, the patient was seen by the physician for abdominal pain which occurred on the other side of her body. The patient was referred to a GI specialist (name not reported). On 24-JUN-2008, the patient had a physical and had no complaints of pain. On 15-JUL-2008, the patient was seen by the GI specialist (results not reported). On 10-SEP-2008, the patient was seen by the physician with complaints of persistent abdominal pain, vomiting. The patient had an abdominal CT scan which was normal. On 30-SEP-2008, the patient was seen in the office for an ADD check and complained of abdominal pain. The physician stated that she wanted to discontinue the FOCALIN XR and the patient requested that she remain on FOCALIN XR therapy. On 20-NOV-2008, the patient was seen in the office with complaints of vomiting. The patient had an MRI of the brain and the results were normal. The patient saw another GI specialist. The patient was seen by the physician on 26-MAR-2009 and was diagnosed with pseudo seizures. The patient was seen by a neurologist (name not reported). On 21-APR-2009, the patient was seen by the physician and at the visit, the patient's mother stated that she thought that her daughter's problems were related to the GARDASIL vaccinations. On 09-MAY-2009, the patient had an EEG kidneys were "ok". The physician did not have any other additional information. No further information is available.