Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Arthralgia, Aspartate aminotransferase normal, Autoimmune hepatitis, Blood albumin decreased
Clinical narrative: Information has been received from a doctor of pharmacy concerning her daughter who in October 2007 was vaccinated with the first dose of GARDASIL. In December 2007 the patient received her second dose of GARDASIL and in July 2008 the patient was vaccinated with the third dose of GARDASIL. It was reported by the pharmacist that since her daughter was given the GARDASIL she has not had a menstrual cycle. Her daughter also had dark spots on her hands, has had an increase in weight gain and hair loss since she started the GARDASIL series. The patient had not recovered at the time of the report. Follow up information was received on 16-JAN-2009: the doctor of pharmacy stated that her daughter was not pregnant. She stated her daughter was an otherwise healthy 14 year old. It was reported that the patient was amenorrheic for almost one year. It was reported that the patient was no taking any other concomitant medication. The pharmacist was concerned regarding the possibility of future fertility problems for her daughter in the near future. The doctor of pharmacy had a full medical evaluation scheduled for her daughter in the near future. This is one of several cases from the same source. Additional information has been requested. This is in follow-up to report (s) previous submitted on 1/11/2009, 8/7/2009. Information has been received from a doctor of pharmacy concerning her daughter who in October 2007 was vaccinated with the first dose of GARDASIL. In December 2007 the patient received her second dose of GARDASIL and in July 2008 the patient was vaccinated with the third dose of GARDASIL. It was reported by the pharmacist that since her daughter was given the GARDASIL she has not had a menstrual cycle. Her daughter also had dark spots on her hands, has had increase in weight gain and hair loss since she started GARDASIL series. The patient had not recovered at the time of the report. Follow up information was received on 16-JAN-2009, the doctor of pharmacy stated that her daughter was not pregnant. She stated her daughter was an otherwise healthy 14 year old. It was reported that the patient was amenhorrheic for almost, one year. It was reported that the patient was not taking any other concomitant medication. The pharmacist was concerned regarding the possibility of future fertility prolems for her daughter in the near future. The doctor of pharmacy had a full medical evaluation scheduled for her daughter in the near future. This is one of several cases from the same source. On 11-AUG-2007, the patient was vaccinated with the first dose of GARDASIL, intramuscularly. On 20-OCT-2007, the patient was vaccinated with the second dose of GARDASIL intramuscularly. Subsequently, in June 2008 the patient was vaccinated with the third dose of GARDASIL, intramuscularly. Follow up information has been received from a physician and a doctor of pharmacy via medical records, concerning a 14 year old female black patient with no known illness at time of vaccination, no known pre-existing allergies and unremarkable past medical history. The doctor of pharmacy reported that after the first injectiona wart occurred on the patient's scalp and she became amenorrhaic and lost her hair. After the second and third injection she has skin discoloration, swellling of legs and stomach and weight gain. On 11-AUG-2007, the patient was vaccinated with the first dose of GARDASIL, intramuscularly. On 20-OCT-2007, the patient was vaccinated with the second dose of GARDASIL intramuscularly. Subsequently, in June 2008 the patient was vaccinated with the third dose of GARDASIL intramuscularly. In February 2009, the patient presented to her primary care physician with lower extremity adema and was found to have elevated liver function test. The physician reported that the patient was ultimately diagnosed with Autoimmune hepatitis and was compliant with outpatient treatment. The patient came to the emergency department (inj on 13-MAR-2009 with complaints of joint pain and jaundice, and was admitted to the pediatric intensive care unit for decompensationdue to liver disease. The patient's liver function rapidly deteriorated, as well as her mental status, and she required intubation as well as dialysis for acute drenal failure. She was placed on the liver transplant on 26-MAR-2009. She was able to be extubated on post operative day#1. Postoperatively she was still required dialysis for approximately 3 weeks ntil she began to make urine. Her last dialysis was on 11-APR-2009, after this her creatinine began to decline. Her LFTs also improved to normalised. She had occasional fevers and leukocytosis for which no source of infectionwas found via cultures or imaging, including computer axial tomography scan. Her white blood cell count eventually began to decline. The patient was deemed stable for discharge home on 22-APR-2009. The patient's labs on discharge were as follows: White blood cell count: 52.89; red blood cell count, 3.15; blood hemoglobin, 9.2; whole blood hematocrit, 27.9, mean corpuscular volume, 97.3, red cell distribution width test, 17.1; blood platelet count, 398, serum sodium test, 142; serum potassium test, 4.4; serum chloride test, 109; total serum carbon dioxide test, 22; serum blood urea nitrogen test, 59; serum creatinine test, 2.9; serum glucose test, 100; serum alkaline phosphatase test, 164; serum albumin test, 2.6; total serum protein test, 6.3; serum aspartate aminotransferase test, 1%; serum alanine aminotransferase test, 10; total serum billirubin, 2.4. The patient's final diagnoses were fulminant liver, autoimmune hepatitis, status post liver transplant, acute renal failure (resolved), respiratory failure (noted 25-MAR-2009; resolved 11-APR-2009). Activehospital problems included tachycardia and artharlgia. Resolved hospital problems include encephalopathy (noted 20-MAR-2009). The patient requires hospitalization for 90 plus days. The physician reported that patient's discharged procedure orders were physicial and occupational therapy with bilateral full weight bearing (weight bearing as tolerated). The discharge medications include: PROTONIX 40mg tablet, PO daily; PROGRAF, 5 mg PO. capuls, two times daily; PROGRAF, 1 mg PO capsule, 4 Capaules two times daily, IMODIUM, 2 mg PO capsule, two times daily as needed for diarrhea/loose stools, kopran, 4 MG po tablet, every 6 hours as needed for nausea, NEUROTIN, 300 mg, PO, capsule tow times daily, CELLCEPT, 250 mg PO capsule, 2 capsules 12 hours, MYCOSTATIN, 100,000 unit/mL PO oral suspension, BACTRIM DS, 260-500 mg PO tablet, every Monday, Wednesday, and Friday morning, DELTASONE, 5 mg PO tablet, 2 tablets every morning. The physician recommended to stop taking ACTIGALL, 100 mg, PO capsule, ALDACTONE, 100 mg PO tablet, multivitamin PO, PURINETHOL, 50 mg PO tablet. Autoimmune hepatitis, hepatic failure, hair loss, skin discoloration, ward occurred on the scalp, respiratory failure, renal failure, weight increased, encephalopathy and amenorrhoea were considered to be other important medical events. Autoimmune hepatitis, hepatic failure, encephalopathy. Acute renal failure and respiratory failure were considered to be disabling and life threatening. Follow up information was received from a registered nurse who reported that on 11-AUG-2007 the patient was vaccinated with the first dose of GARDASIL (Lot No. 658282/0929U). On 13-OCT-2007 (also reported as 290OCT-2007) the patient was vaccinated wish the second dose of GARDASIL. Subsequently, on 26-FEB-2009 the patient was vaccinated with the third dose of GARDASIL (Lot No. 659441/1446U). The nurse was unable to provide the patient's current status. A lot check has been initiated. No further information is available. All available medical records will be provided upon request.