VAERSの検索で、ＨＰＶワクチンと 遺伝子変異検査陽性を入れると、６件ヒットします。
Write-up: Traveled from 3/3/07-3/10/07. On 3/6/07 had calf pain that traveled to the thigh. On 3/19/07, went to Medical Center ER for severe pain in lower back. Two large clots found in lung (pulmonary embolus). Admitted for heparin treatment for a few days. Discharged on Coumadin for 6 months. Has lingering pain in lower back and damage to the lung. Had started taking BCP''s for the first time in approx. Feb. 0f 2007. Had genetic testing done after the pulmonary embolus which showed that she has a prothrombin genetic mutation （プロトロンビン遺伝子変異）, elevated lipoprotein and hemocystine line. 05/21/2007 MR received form treating hospital. Initially presented to ED on 3/19/2007 with c/o Right back pain which was worse upon lying down, as well as pain in chest which was worse with deep breathing. The pain radiated to the Right shoulder. Had been having some Right leg discomfort while traveling prior to ED visit PMH: Recent travel with 2 flights x 3hrs. On BCP. Admitted with the following DX: LBP, R Flank pain, Pulmonary Embolism, Pulmonary Infarct. Pulmonary Critical Care consult with DX; Pulmonary Embolism and Infarct. Pt. returned to ER on 3/25/07 with c/o calf pain since that morning. Still c/o SOB x 1 week. DX: Calf pain.
Write-up: weight loss, nausea & vomiting, malaise. 5/20/08 Office records received including vax record. Seen for sick visit 5/01/08 with c/o nausea, vomiting, and stomach feeling whoozy x 1 month. Impression Nausea & Vomiting. Tx with metoclopramide. Seen again 5/5/08 with c/o sore throat, nausea, back pain. Impression: N&V, Bilirubinuria, pancytopenia. Referral made to Oncologist. 07/01/2008 MR received for DOS 05/7-31/2008 with D/C DX: Acute Myeloid Leukemia. Pt presented with pancytopenia for eval to r/o acute leukemia. Bone marrow bx confirmed AML. (急性骨髄性白血病) Started on chemo which initially was well tolerated but later developed severe abdominal c/o with hematochezia. DX with pancolitis, likely infectious. Pt had intermittent high fevers and hypotension. Pt developed a clot in her PICC line and it was removed. Blood counts somewhat recovered and pt d/c 5/31/08.
Write-up: Information has been received from a 24 year old female with family history of blood clots, her grandmother and mother were factor 5（血液凝固第V因子）, and no drug reactions/allergies who in April 2009, was vaccinated with the first dose of GARDASIL (Lot # not reported). In June 2009, the patient was vaccinated with the second dose of GARDASIL (Lot # not reported). Concomitant therapy included hormonal contraceptives (unspecified). On 06-JUL-2009, the patient was diagnosed with a blood clot and was admitted to the hospital for less than 1 day. On an unspecified date, the patient had a factor 5 test and an ultrasound performed (results not provided). In the end of July 2009, the patient recovered from blood clot. Additional information has been requested. 9/18/09 Hospital records received DOS 7/8/09 to 7/9/09. Assessment: Acute deep venous thrombosis in right leg. Soft ball injury to leg, multiple abrasions 1 week prior. Presents with exquisite right calf pain. Superficial phlebitis of right lesser sapheous, occluded calf vein, thrombosis of right gastronemius vein, occluded deep vein thrombosis of right superficial femoral and popliteal veins. ICD-9 Codes: 782.3 Edema, 451.0 Superfic Phlebitis - Leg, 916.0 Abrasion Hip & Leg, 346.90 Migrne Unsp wo Ntrc Mgrn, V18.3 HX-Blood Disord Nec.
Write-up: Information has been received from a physician concerning a 19 year old female who on an unspecified date was vaccinated with a dose of GARDASIL (lot # not reported, dose number unknown). Approximately a year and a half prior to developing the onset of rapidly progressive ALS (amyotrophic lateral sclerosis). It was unknown if the patient was on any medications or had concomitant vaccinations. Patient died within a year of symptom onset. Patient was found to be positive for a genetic mutation (FUS) recently recognized as associated with early-onset, rapidly progressive ALS. Her parents also had the mutation. It was not reported if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
この方は亡くなっています。日本でも、ＦＵＳ変異で亡くなった方の報告がありました。
Write-up: Information has been received from a nurse practitioner (NP) concerning a 14 year old female patient with family history of a blood clotting disorder and MTHFR gene abnormality who on an unknown date, was vaccinated with the first dose of GARDASIL (lot# 0298AA, expiration date: 21-JUN-2013) (dose and route were not reported). The patient did not receive any concomitant medication. Two days later, on 07-DEC-2011, the patient fainted. The nurse practitioner stated that before the patient was placed on hormonal contraceptives (unspecified) on 05-DEC-2011, she had laboratory test drawn, to test for blood clotting abnormalities. The patient was diagnosed with MTHFR gene abnormality. The patient was hospitalized in an unknown hospital for an unspecified period of time. The Nurse practitioner stated that the patient''s mother reported that on an unknown date, the patient had taken her first dose of birth control medication and the day after the patient fainted at school. The patient was taken to the hospital. Then the patient was transferred to another hospital. The patient again was transferred to another hospital. The patient''s mother reported that it was determined that the patient''s MTHFR gene abnormality was not related to the patient''s fainting. It was also reported that on an unknown date the patient had weakness and she had just "started to walk again". At the time of the report patient''s outcome was unknown. Follow up information was received from the nurse practitioner concerning a 14 year old female student with no pre-existing allergies, birth defects or medical conditions (previously reported as having a history of blood clotting disorder and MTHFR gene abnormality) （メチレンテトラヒドロ葉酸還元酵素遺伝子異常） and no illness at the time of vaccination who on 05-DEC-2011 at 16:00, was vaccinated in the left deltoid with the first dose of GARDASIL (lot# 0298AA, expiration date: 21-JUN-2013) (dose and route were not reported). The nurse reported that at the time of injection no problems occurred. Seven days later, on 12-DEC-2011, the mother called and said that on 12-DEC-2011 at 13:00, the patient had passed out at school and was taken to ER (previously reported also as on 07-DEC-2011). The patient was hospitalized off and on since the event because of neurological deficit, low extremities (LE) weakness, foot drop and inability to walk. At the time of the report, the patient had not recovered. Passed out, neurological deficit, low extremities (LE) weakness, foot drop and inability to walk were considered by the nurse to be disabling. Additional information has been requested.
Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control # E2014-02428) on 21-MAR-2014. Case received from the Health Authorities on 17-Mar-2014 under the reference number CF20140104. A 15-year-old female patient had received intramuscularly the three doses of GARDASIL (batch number unknown) on 14-May-2013, 16-Jul-2013, and 19-Nov-2013. She had no relevant medical history, no allergic diathesis, and was not taking any contraceptive pill. She was treated with DOXY 50 per os for acne since March 2013 up to 01-Sep-2013 with a stop during the summer. On 01-Sep-2013, treatment was increased to DOXY 100. On 02-Dec-2013, the patient saw her general practitioner due to asthenia. Subicterus was noticed. On 03-Dec-2013, a biological work-up put forward a major cytolysis (ASAT 745 IU/L, ALAT 920), high Gamma GT at 169, total bilirubin at 83.8 and conjugated bilirubin at 71.8, i.e. higher than normal range. The work-up was subsequently completed and was very much suggestive of a type 1 autoimmune hepatitis: ANCA positive, smoother muscle antibodies positive, anti-actin antibodies positive, myeloperoxidase antibodies positive and proteinase-3 antibodies negative. The following virus serology tests revealed negative: HAV, HBV, HCV, HEV, CMV, HSV 1+2 (IgM) and toxoplasmosis. Epstein-Barr virus test was compatible with a former serology, and TSH was normal. DOXY 100 was immediately stopped within the week, i.e. on 09-Dec-2013. On 06-Dec-2013: ASAT 835, ALAT 904 and GGT 149. On 09-Dec-2013: ASAT 837, ALAT 975 and GGT 128. On 12-Dec-2013: ASAT 925, ALAT 959 and GGT 120. On 19-Dec-2013, the patient was hospitalized so as to perform a liver biopsy. Anatomopathological analysis of the liver biopsy evidenced significant lesions of portal hepatitis with extensive periportal necrosis, and numerous porto-portal bridges. Those morphological findings were fully compatible with type 1 autoimmune hepatitis. From an hematologic standpoint, haemoglobin was at 12.3 g/dl and mean corpuscular volume at 91 fl. White cell blood count and platelets were normal. Prothrombin time was at 76%, activated partial thromboplastin time and occlusion time were normal. On 20-Dec-2013, a treatment was initiated by CORTANCYL 60 mg oad and IMUREL 100 mg oad. The patient went to see a dietician to adapt her food. Treatment with calcium, vitamin D was added to the treatment with CORTANCYL and IMUREL, as well as a proton pump inhibitor. Gene mutation identification for thiopurin S methyltransferase （チオプリンメチル基転移酵素）found the presence of 2 mutations 3B and 3C in heterozygotes form associated to a reduction of the thiopurin S methyltransferase metabolic capacity for thiopurine drugs. Action to be taken for such cases was to reduce the dosage from 0.2 to 0.3 mg/kg/day. The patient''s rate of IMUREL was of 1.7 mg/kg/day instead of 2 mg/kg/day. Consequently the dosage of IMUREL 100 mg oad was maintained for the moment with close medical supervision of the blood count. On 02-Jan-2014, liver work-up had clearly improved: ASAT 107, ALAT 365 and GGT 144. The improvement subsequently carried on. ASAT became normal, ALAT and GGT got stable at 2N in the two last available work-ups. 20-Jan-2014: ASAT 39, ALAT 119 and GGT 99. 03-Feb-2014: ASAT 36, ALAT 71 and GGT 79. 17-Feb-2014: ASAT 32, ALAT 70 and GGT 74. The Health Authorities report concluded to a serious and life-threatening adverse event. Treatment by CORTANCYL and IMUREL was initiated. The evolution was favourable with a probable future decrease of the corticosteroids considering the evolution of transaminases. According to the Health Authorities, drug induced etiology, whether GARDASIL or DOXY, was doubtful. The Health Authorities specified that causality was assessed without being detrimental to the findings of any investigations which might be performed in the context of legal or out-of-court procedures for compensation.
