小径線維ニューロパチーが含まれる症例 スウェーデン （メルクがVaersに報告）

病歴として、抗環状シトルリン化ペプチド抗体が陽性の関節リウマチ　２００９年

投与経路のミス：　ガーダシル皮下注射

VAERS ID:

	532283 (history)	Vaccinated:	2013-10-02
Age:	25.0	Onset:	2013-10-15, Days after vaccination: 13
Gender:	Female	Submitted:	2014-05-29, Days after onset: 226
Location:	Foreign	Entered:	2014-05-29

	Life Threatening? No Died? No Permanent Disability? No Recovered? No ER or Doctor Visit? Yes Hospitalized? Yes, ? days     Extended hospital stay? No Previous Vaccinations: Other Medications: ENBREL; Prednisolone; RELIFEX; ALVEDON; CITODON; CALCICHEW D3; YASMIN 28; SYMBICORT TURBUHALER; SINGULAIR Current Illness: Immunisation; Pain; 2009, Rheumatoid arthritis, anti-citrullinated protein antibody (ACPA)-positive Preexisting Conditions: Tendon operation; Asthma; GARDASIL, Vaccination error, subcutaneous administration was used instead of intramuscular; HUMIRA, Rash; ARAVA, Stevens-Johnson syndrome; 08/01/2013, GARDASIL, Incorrect route of drug administration, D1 GARDASIL (batch number H07225) via subcutaneous route of administration in not reported site Diagnostic Lab Data: Anti-cyclic citrullinated peptide antibody positive, rheumatoid arthritis; Electromyogram, showed signs of small fibre neuropathy; Electroneurography, showed signs of small fibre neuropathy CDC Split Type: WAES1405SWE013869
Vaccination Manufacturer Lot Dose Route Site HPV4: HPV (GARDASIL) MERCK & CO. INC.   1 SC UN
Administered by: Other     Purchased by: Other Symptoms: Anti-cyclic citrullinated peptide antibody positive, Balance disorder, Dizziness, Electromyogram abnormal, Electroneurography, Fall, Gait disturbance, Headache, Hypoaesthesia, Incorrect route of drug administration, Laboratory test abnormal, Rheumatoid arthritis, Small fibre neuropathy, Thermogram abnormal SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Vestibular disorders (broad), Arthritis (narrow), Medication errors (narrow), Hypoglycaemia (broad) Write-up: Information has been received from SPMSD (MFR# SE-1577272925-E2014-04526) on 26-MAY-2014. Case of vaccination error received from physician via Health Authorities on 21-May-2014 under the reference number SE-MPA-2014-003072. The primary reporter was a physician. This is a case of vaccination error as the patient was vaccinated with GARDASIL via subcutaneous route of administration, for an unknown reason. A 25-year-old female patient with a medical history of rheumatoid arthritis in 2009 (anti-citrullinated protein antibody (ACPA) positive), tendon operation and asthma, had received the second dose of GARDASIL (batch number H07225) via subcutaneous route of administration in not reported site of administration on 02-Oct-2013 and ENBREL (50 mg, other MFR, batch number not reported) via subcutaneous route of administration, stared on 14-Jan-2010. Later on 15-Oct-2013, she developed small fibre neuropathy. She became ill with increasing numbness from the knee down, aggravation walk difficulties, headache, dizziness, unsteadiness, difficulty walking due to balance problems and she fell a few times without syncope. The patient was, at the time of reporting, not yet recovered. At the time of the event the patient was concomitantly treated with prednisolone, RELIFEX for pain, ALVEDON for pain, CITODON, CALCICHEW-D3, YASMIN 28 (film coated tablet), SYMBICORT TURBUHALER (160 micrograms/4.5 micrograms, inhalation) and SINGULAIR (10 mg film coated tablet). The patient received the third dose of GARDASIL (batch number H07225) via subcutaneous route of administration in not reported site of administration on 30-Jan-2014. The patient was investigated by a neurologist, normal samples except EMG-ENeG conducted in February (exact date not specified) that showed signs of small fibre neuropathy with reduced thresholds on thermography. ENBREL was discontinued a few months during November-December with no real improvement. Treatment with gabapentin (other MFR) was started. Reporting neurologist wrote that the cause of the neuropathy was unclear and that least three different hypotheses could be considered: adverse reaction from ENBREL (has, however, been treated for over three years and at discontinuation no improvement was seen), adverse reaction from GARDASIL (Guillain-Barre like condition is described in the SmPC) or as a part of the Rheumatoid Arthritis disease (however, has been well treated). The patient has a history of severe adverse reactions such as Stevens-Johnson like reaction during ARAVA (other MFR) treatment and severe rash from HUMIRA (other MFR). The patient was previously vaccinated with D1 GARDASIL (batch number H07225) via subcutaneous route of administration in not reported site of administration on 01-Aug-2013. At the time of reporting the outcome for small fibre neuropathy was not recovered. Outcome for all other events was unknown. According to HA, the reaction was possibly related to all three GARDASIL vaccinations and ENBREL. Noteworthy: The HA has assessed the seriousness criteria as hospitalization (no further information provided). Company judged relevant to code only the second dose of GARDASIL as suspect. Lot# H07225 is a invalid lot number for GARDASIL.

子宮頸がんワクチン後の高安動脈炎

 

VAERS ID:

	332180 (history)	Vaccinated:	2008-03-18
Age:	18.0	Onset:	2008-11-03, Days after vaccination: 230
Gender:	Female	Submitted:	2008-11-07, Days after onset: 4
Location:	Unknown	Entered:	2008-11-12, Days after submission: 5

	Life Threatening? No Died? No Permanent Disability? Yes Recovered? No ER or Doctor Visit? No Hospitalized? Yes, 1 days     Extended hospital stay? No Previous Vaccinations: Other Medications: Current Illness: Preexisting Conditions: Healthy female Diagnostic Lab Data: CT angiogram thoracoabdominal aorta - moderate right subclavian and mild left subclavian artery stenosis. Severe narrowing of abdominal aorta, celiac, SMA, and bilateral renal artery stenosis. 11/20/08-records received-MRI spine unremarkable. Renal ultrasound elevated velocities in aorta and renal arteries. BUN 14, potassium 5.4, urinalysis shows white cell. CT angiogram revealed bilateral renal artery stenoses, celiac trunk stenosis and tapering of suprarenal aorta. Echocardiogram normal. CRP elevated 1.1, sed rate elevated 58. CDC Split Type:
Vaccination Manufacturer Lot Dose Route Site HPV4: HPV (GARDASIL) MERCK & CO. INC. 1978U 2 IM RA
Administered by: Unknown     Purchased by: Unknown Symptoms: Anaemia, Angiogram, Angiogram abnormal, Aortic stenosis, Back pain, Blood potassium increased, Blood pressure increased, C-reactive protein increased, Coeliac artery stenosis, Echocardiogram normal, Eye swelling, Headache, Oedema peripheral, Pain in extremity, Rash macular, Red blood cell sedimentation rate increased, Renal artery stenosis, Renovascular hypertension, Subclavian artery stenosis, Takayasu's arteritis, White blood cells urine positive SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Haematopoietic erythropenia (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Vasculitis (narrow), Renovascular disorders (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad) Write-up: Diagnosed with Takayasu arteritis (rare disease). Chronic back pain 3 months after 1st vaccination. Headaches in summer 2008. Elevated B/p in June 08. 11/20/08-records received-office note 11/20/07-C/O 3 month history of mid back pain. Impression mid back strain. 10/09/08-ambulatory BP monitor-hypertension.Major component stress and anxiety. 6/24/08-C/O headaches. DX: Takayasu arteritis. Hospitalized for lower extremity edema and blotchy legs on 11/3/08. 12/31/08-records received for DOS 11/3/08-admitted after just started amlodipine with C/O ankle swelling and blotchy rash, admitted for evaluation of vaculitis. Headaches begin in June 2008 and elevated blood pressure. Eye swelling, achy legs when walking. Mild anemia with hemoglobin 10. Renal doppler showed elevated velocities but no renal artery stenosis. CT scan showed renal artery stenosis. Impression:renovascular hypertension due to bilateral renal artery stenosis, Takayasu arteritis.

 

VAERS ID:

	438763 (history)	Vaccinated:	2011-09-01
Age:	17.0	Onset:	2011-09-28, Days after vaccination: 27
Gender:	Female	Submitted:	2011-10-17, Days after onset: 19
Location:	Foreign	Entered:	2011-10-17

	Life Threatening? No Died? No Permanent Disability? No Recovered? No ER or Doctor Visit? No Hospitalized? Yes, ? days     Extended hospital stay? No Previous Vaccinations: Other Medications: Current Illness: Unknown Preexisting Conditions: Diagnostic Lab Data: Imaging procedure, Suspected aortitis CDC Split Type: B0754919A
Vaccination Manufacturer Lot Dose Route Site HPV2: HPV (CERVARIX) GLAXOSMITHKLINE BIOLOGICALS     IM UN
Administered by: Other     Purchased by: Other Symptoms: Imaging procedure, Pyrexia, Takayasu's arteritis SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vasculitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad) Write-up: This case was reported by a physician and described the occurrence of suspected aortitis syndrome in a 17-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent vaccination included CERVARIX; GlaxoSmithKline given in August 2011. In September 2011, the subject received unspecified dose of CERVARIX (intramuscular, unknown site of injection, batch number not provided). On 28 September 2011, less than one month after vaccination with CERVARIX, the subject experienced fever. At an unspecified time after vaccination with CERVARIX, the subject developed aortitis syndrome. The subject was hospitalised. At the time of reporting the outcome of the events was unspecified. The physician considered the events were unrelated to vaccination with CERVARIX.

 

VAERS ID:

	447916 (history)	Vaccinated:	2011-02-22
Age:	15.0	Onset:	2011-03-01, Days after vaccination: 7
Gender:	Female	Submitted:	2012-01-24, Days after onset: 329
Location:	Foreign	Entered:	2012-01-24

	Life Threatening? No Died? No Permanent Disability? No Recovered? No ER or Doctor Visit? No Hospitalized? Yes, ? days     Extended hospital stay? No Previous Vaccinations: Other Medications: Current Illness: Unknown Preexisting Conditions: Diagnostic Lab Data: UNK CDC Split Type: B0776557A
Vaccination Manufacturer Lot Dose Route Site HPV2: HPV (CERVARIX) GLAXOSMITHKLINE BIOLOGICALS   0 IM UN
Administered by: Other     Purchased by: Other Symptoms: Juvenile arthritis, Takayasu's arteritis SMQs:, Vasculitis (narrow), Arthritis (narrow) Write-up: This case was reported by a physician and described the occurrence of juvenile idiopathic arthritis in a 15-year-old female subject of unspecified age who was vaccinated with CERVARIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of CERVARIX (intramuscular, unknown site of injection, batch number not provided). At an unspecified time after vaccination with CERVARIX, the subject experienced Takayasu''s disease. At the time of reporting the outcome of the event was unspecified. Additional information received on 19 January 2012: On 19 January 2012, this case was upgraded from non serious case to serious adverse event. On 22 February 2011, the subject received the 1st dose of CERVARIX (0.5 ml, intramuscular, unknown site of injection, batch number not provided). On 22 March 2011, the subject received the 2nd dose of CERVARIX (0.5 ml, intramuscular, unknown site of injection, batch number not provided). In March 2011, the subject presented juvenile idiopathic arthritis. On 22 August 2011, the subject received the 3rd dose of CERVARIX (0.5 ml, intramuscular, unknown site of injection, batch number not provided). In October 2011, 2 months after 3rd dose of inoculation of CERVARIX, the subject presented Takayasu''s disease. At time of reporting, the events were unresolved.

サーバリックス後のＴＩＮＵ症候群 ２例

 

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VAERS ID: 371444 (history)   Vaccinated: 2008-05-13 Age: 15.0   Onset: 2008-07-09, Days after vaccination: 57 Gender: Female   Submitted: 2009-12-03, Days after onset: 512 Location: Foreign   Entered: 2009-12-03	Life Threatening? No Died? No Permanent Disability? No Recovered? No ER or Doctor Visit? Yes Hospitalized? Yes, 2 days     Extended hospital stay? No Previous Vaccinations: Other Medications: Current Illness: Unknown Preexisting Conditions: Diagnostic Lab Data: Albumin, 13 Aug2008, 31.2MG/L; Albumin, 06Nov208, 7.4MG/L; Alkaline phosphatase, 13Aug2008, 73U/L, 80, 210; Alpha 1 microglobulin urine, 13Aug2008, 42.7MG/L, 8; Alpha 1 microglobulin urine, 06Nov2008, 5.2MG/L, 8; Blood Creatine, 21Jul2008, 120UMOL/L, 45, 90; Blood Creatine, 28Jul2008, 129UMOL/L, 45, 90; Blood Creatine, 31Jul2008, 143UMOL/L, 45, 90; Blood Creatine, 04Aug2008, 150UMOL/L, 45, 90; Blood Erythrocyte, 28Jul2008, 3, 72E12/L, 3, 90, 5, 20; Blood Erythrocyte sedimentatio, 21Jul2008, 107MM/H, below 15; Blood Erythrocyte sedimentatio, 23Jul2008, 99MM/H, below 15; Blood Erythrocyte sedimentatio, 13Aug2008, 70MM/H, 0, 15; Blood Erythrocyte sedimentatio, 11Sep2008, 20MM/H, below 15; Blood Erythrocyte sedimentatio, 06Nov2008, 10MM/H, 0, 1 CDC Split Type: R0000665A
Vaccination Manufacturer Lot Dose Route Site HPV2: HPV (CERVARIX) GLAXOSMITHKLINE BIOLOGICALS   1 IM AR
Administered by: Other     Purchased by: Other Symptoms: Albumin urine present, Alpha 1 microglobulin urine, Arthralgia, Beta 2 microglobulin normal, Beta 2 microglobulin urine normal, Blood albumin decreased, Blood alkaline phosphatase normal, Blood calcium increased, Blood creatine increased, Blood glucose decreased, Blood parathyroid hormone normal, Blood potassium normal, Blood sodium normal, Blood urea normal, C-reactive protein increased, Constipation, Creatine urine, Cystatin C, Decreased appetite, Fatigue, Glucose urine absent, Haematocrit normal, Haemoglobin increased, Joint swelling, Ocular hypertension, Platelet count normal, Pyrexia, Red blood cell count normal, Red blood cell sedimentation rate increased, Tubulointerstitial nephritis and uveitis syndrome, Urine protein/creatinine ratio decreased, Weight decreased, White blood cell count normal SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (narrow), Chronic kidney disease (broad), Arthritis (broad), Proteinuria (narrow), Tubulointerstitial diseases (narrow), Tendinopathies and ligament disorders (broad) Write-up: The subject was enrolled in the prophylactic study which is open or single blind according to communities. On 15 April 2008 and on 13 May 2008, the subject received the 1st and 2nd dose of CERVARIX, IM deltoid. On 09 July 2008, 57 days after the 2nd dose of CERVARIX, this 15 year-old subject developed tubulointerstitial nephritis and uveitis syndrome. The subject was hospitalized and the event was clinically significant (or requiring intervention). The subject was treated with PREDNISONE, OMEPRAZOLE, DEXAMETHASONE, HYOSCINE and DORZOLMAIDE/ TIMOLOL ophthalmic solution. The event improved on an unspecified date. The investigator considered that there was a reasonable possibility that the tubulointerstitial nephritis and uveitis syndrome may have been caused by CERVARIX. Subsequent study vaccine administration was discontinued. The subject received investigational vaccine I and II on 15 April 2008 and 13 May 2008. One and a half month later the subject developed fever approx 38 Celsius degrees that lasted for a month. She had no symptoms of respiratory-infections, no abnormal pain, no headache. She had tiredness, loss of appetite, weight loss of 4 kilos in a month. No urticaria. No arthralgia except of right knee pain when lying with knees flexed. One month of constipation symptoms. She was first examined in hospital (report missing) and then in the hospital. She was admitted to the hospital for kidney biopsy. The subject was free of findings when examined on 23 July 2008 by a pediatrician. Lab tests were normal except for ESR (erythrocyte sedimentation rate), CRP (c-reactive protein), Creatine, urea and glycosuria. Rheumatoid disease, diabetes, tularemia, epidemic nephropathy, Borrelia, EBV (Epstein-Barr Virus) - kampylo and Yersinia - infections were excluded. Culture of urine and faces were normal. An ultrasound of the abdomen and kidneys were normal. Chest and sinus x-rays were normal. Because of ongoing fever and lab test findings TINU was suspected. An Opthamologist was consulted and acute iritis was found in both eyes on 05 August 2008. Topical medication was started. She was referred to the hospital for a kidney biopsy on 07 August 2008 (hospital stay 06-08 August 2008). The biopsy finding was some improvement in lab finding. The subject was still in good condition but she had pain and some swelling in the knees. The iritis was followed and got better. At visit on 11 September 2008, no changes in findings or symptoms but the lab tests were normal except for ESR 20mm/h. There is a probability that the subject got the TINU-syndrome because of the vaccination, so she did not receive third vaccine. Follow-up controls had been arranged in hospital. On a control visit 06 November 2008 the subject was in good medical condition. PREDNISOLON medication was stopped on 14 November 2008. On 30 December 2008, the iritis activated again and topical medication was started for 8 weeks and a follow-up control was arranged. A kidney function test made on 15 January 2009 (GFR-test=glomerular filtration rate) showed a slightly lowered kidney function (79ml/min/1.73m2, normal range 75-134 ml/min/ 1.73m2) but other blood tests showing kidney function were normal. The GFR-test will be repeated after half a year. On a follow-up contact on 16 January 2009 the iritis was improved. The topical medication was diminished and stopped on 24 February 2009. On 24 February 2009 the iritis had improved but there was a bit hypertension in both eyes. Dexa-drops were discontinued but drops for ocular hypertension continued until 03 March 2009. The eye pressure were normal on 20 March 2009. A pediatrician follow-up control on 01 June 2009; the subject was in good condition except for common allergic symptoms. Status was normal. On 28 August 2009 she went to an ophthalmologist because of symptoms of iritis. There was a mild iritis in both eyes and topical medication was started. On a follow-up control on 22 September 2009 the condition had improved and medicat

 

 

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VAERS ID: 457612 (history)   Vaccinated: 2012-03-01 Age: 14.0   Onset: 2012-04-01, Days after vaccination: 31 Gender: Female   Submitted: 2012-06-18, Days after onset: 78 Location: Foreign   Entered: 2012-06-18	Life Threatening? No Died? No Permanent Disability? No Recovered? No ER or Doctor Visit? No Hospitalized? No Previous Vaccinations: Other Medications: Current Illness: Unknown Preexisting Conditions: Diagnostic Lab Data: UNK CDC Split Type: B0808463A
Vaccination Manufacturer Lot Dose Route Site HPV2: HPV (CERVARIX) GLAXOSMITHKLINE BIOLOGICALS   2 IM UN
Administered by: Other     Purchased by: Other Symptoms: Tubulointerstitial nephritis and uveitis syndrome SMQs:, Tubulointerstitial diseases (narrow) Write-up: This case was reported by a physician and described the occurrence of tubulointerstitial nephritis and uveitis syndrome in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). In March 2012, the subject received 3rd dose of CERVARIX (intramuscular, unknown site of injection, batch number not provided). In April 2012 (during the first 10 days of the month), 1 month after vaccination with CERVARIX, the subject experienced tubulointerstitial nephritis and uveitis syndrome. The physician considered the event was clinically significant (or requiring intervention). At the time of reporting, the outcome of the event was unspecified.

記憶障害の御三家

ＶＡＥＲＳのデータを、症状の項目が、「記憶障害」で検索した結果です。

データの登録を始めてから、７５０例の「記憶障害」の報告があった模様です。

左のアルファベットの記号は、ワクチンの名称です。

報告数の多いものだけ、上から順番に

ＡＮＴＨは、炭疽ワクチンです。１０８例の報告、ほとんどが、軍隊関係者（military）です。

ＦＬＵ３は、インフルエンザワクチンのフルゾン（サノフィー・パスツール社）で、１１４例です。

ＨＥＰは、Ｂ型肝炎ワクチン、メルク社のRECOMBIVAX HBと、グラクソのENGERIX-Bなどで、１４５例。

ＨＰＶ４がガーダシルで、１４１例

ＨＰＶ２のサーバリックスが、３６例、普通、Ｖａｅｒｓの報告だとガーダシルとサーバリックスの比率が１０：１強なので、

比率的にサーバリックスが２倍となっています。

 

接種数の総数を調べていないので、ＨＰＶワクチンとインフルエンザ、Ｂ型肝炎のワクチンとは比べられませんが、

この３つとも、記憶障害を起こす例が多数報告されていることは事実です。

ガーダシルとサーバリックスは、接種後に産生されたサイトカイン等のプロフィールが異なるので

この違いがＢＢＢの透過性に影響を与えている可能性があると考えられます。

すべてのワクチンで、自己抗体ができていても、サーバリックスだけがＢＢＢを通過させる能力が高いのかもしれません。

 

 

ＬＹＭＥは、グラクソの前身の、スミスクライン・ベッチャムのライムワクチンで、自己免疫疾患の副反応で問題になったワクチンです。記憶障害が４６例。

Lipoproteins have been also used in experimental and clinical vaccine studies. In a vaccine against Lyme disease, immunization with the B. burgdorferi outer surface lipoprotein A (OspA) with alum has shown enhanced secretion of protective antibodies against a C-terminus epitope of OspA [108]. This Lyme disease vaccine, LYMErix®, was licensed in 1998 after showing a good safety profile in clinical trials. However, potential concerns regarding skewing of Treg responses toward a Th17 phenotype and induction of autoimmune disease have stopped its commercialization [109].

 

 

 

Vaersに報告されたぶどう膜炎

Ｂ型肝炎ワクチン　９５例

ガーダシル　４２例

サーバリックス　５例

 

Ｂ型肝炎ワクチンの場合、症状が、ぶどう膜炎だけというのが結構あるが、

ＨＰＶワクチンの場合、症状が、１０以上並んでいるものが多いという特徴がある。

 

 

強直性脊椎炎とHLA－B27

全米ワクチン健康被害補償プログラムで補償されたケースの疾患のひとつ、

強直性脊椎炎は、HLA-B27と関連しています。

強直性脊椎炎の患者の９０％は、HLA-B27陽性です。

HLA-B27陽性の人で、強直性脊椎炎を発症する人は１％程度だそうです。

VAERS ID:

	308474 (history)	Vaccinated:	2007-08-27
Age:	21.0	Onset:	2008-02-20, Days after vaccination: 177
Gender:	Female	Submitted:	2008-03-24, Days after onset: 32
Location:	Indiana	Entered:	2008-03-28, Days after submission: 4

	Life Threatening? No Died? No Permanent Disability? No Recovered? No ER or Doctor Visit? No Hospitalized? No Previous Vaccinations: Other Medications: Current Illness: None Preexisting Conditions: Osteopenia; Hypercalciuria 4/10/08-records received-PMH:ADHD. stress fracture. Osteopenia. Hypercalcuria. HPV#2 given 10/31/07, Lot # 1265U; HPV#3 given 2/20/08, Lot # 1486U. Diagnostic Lab Data: 5/2/08-records received-ANA 1:1280 and leg pain. WBC 3.27. Sedimentation rate elevated 27.MRI anterior vertebral column mass. Unilateral right L5 pars defect with subtle anterolisthesis, low grade left pedicle stress reaction and shallow rightward protrusion without overt neural effacement. Labs & Diags: MRI Spine: no evidence of ankylosing spondylitis, lymphocele, bone bx- no underlying etiology for fractures. CDC Split Type:
Vaccination Manufacturer Lot Dose Route Site HPV4: HPV (GARDASIL) MERCK & CO. INC. 0930U 0 IM UN
Administered by: Private     Purchased by: Private Symptoms: Ankylosing spondylitis, Antinuclear antibody positive, Arthralgia, Arthritis, Back pain, Biopsy site unspecified normal, Bone scan abnormal, Chest pain, Connective tissue disorder, Disability, Dizziness, Fatigue, HLA marker study positive, Hypoaesthesia, Injection site pain, Joint stiffness, Lung disorder, Myalgia, Night sweats, Nuclear magnetic resonance imaging abnormal, Pain, Pallor, Paraesthesia, Pyrexia, Rash, Rash macular, Red blood cell sedimentation rate increased, Spondylolisthesis, Stress fracture, Urticaria, Weight decreased, White blood cell count decreased SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Haematopoietic leukopenia (narrow), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Osteonecrosis (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Arthritis (narrow), Tendinopathies and ligament disorders (broad) Write-up: 1st shot - 8/27/2007 - felt like nurse put needle in bone, light headed, turned white, pain at injection site for 3 days. 2nd shot - 10/31/2007 - sore at injection site. 3rd shot - 2/20/2008 - site severe pain in muscles, joints, arm hurt for 3 days.4/10/08-office records received- 5/2/08-records received for DOS 3/11/08- Chief complaint: abnormal Positive ANA, high sed rate, after shots, achy joints, pain has increased since fall 2007, put on Prednisone 3/18/2008. Presented with recurring stress fractures, four since high school. Chronic pain increasing since last fall. 12/2/09 Other correspondence and medical records received. Medical records DOS 3/4/09: Final DX: Abnormal weight loss, arthralgias and joint stiffness, elevated sed rate, and positive ANA consistent with polyarthralgia blotchy rash, urticarial rash, HLA B27 positive, back pain out of proportion to other joint pains--suspicious for spondyloarthritis in setting of seronegative arthritis, Lymphocele is seen at T12 through L2 and MR lumbosacral area. Pulmonary nodules, previous Gardasil immunization prior to onset of rheumatologic symptoms, positive SSA, multiple stress fractures, mostly asymptomatic, abnormal bone scan, bone biopsy pending after tetracycline loading. Gardasil vaccine questionnaire noting the following sx beginning after vaccine #1 and continuing throughout vaccine series: dizziness, numbness, tingling, joint pain, muscle pain at inj site, rashes, blisters or skin disorders, extreme fatigue, weight loss, joint stiffness, night sweats, fevers, back pain, chest pain. All increasing over time. Short term steroid therapy no help. Unable to complete ADLs some days, often debilitating. C/O Ankylosing spondylitis and connective tissue disorder s/p vaccines. ICD9 Codes: Noted as indication for MRI of spine 721.90, 724.5

何らかの抗体が陽性と報告された数

ガーダシル　307例

サーバリックス　24例

ガーダシル９　1例

 

 

 

Anti-actin antibody positive	1	0.3%
Anti-aquaporin-4 antibody positive	1	0.3%
Anti-cyclic citrullinated peptide antibody positive 関節リウマチに関与	14	4.15%
Anti-insulin antibody positive	1	0.3%
Anti-NMDA antibody positive	1	0.3%
Anti-platelet antibody positive	3	0.89%
Anti-SS-A antibody positive	7	2.08%
Anti-SS-B antibody positive	6	1.78%
Anti-thyroid antibody positive	34	10.09%
Anti-VGKC antibody positive http://www.shizuokamind.org/wp-content/uploads/2012/03/scheme20130317.pdf	1	0.3%
Antiacetylcholine receptor antibody positive	5	1.48%
Antibody test abnormal	3	0.89%
Antibody test positive	11	3.26%
Antiendomysial antibody positive　（セリアック病示唆）	1	0.3%
Antigliadin antibody positive （グルテン過敏示唆）	6	1.78%
Antineutrophil cytoplasmic antibody positive 顕微鏡的多発血管炎(MPA)、多発血管炎性肉芽腫症、好酸球性多発血管炎性肉芽腫症(EGPA)などで陽性になる	10	2.97%
Antinuclear antibody increased　（抗核抗体増加）	10	2.97%
Antinuclear antibody positive　（抗核抗体陽性）	139	41.25%
Antiphospholipid antibodies positive　（抗リン脂質抗体陽性）	16	4.75%

重症筋無力症 （myasthenia gravis)

サーバリックス　１例

ガーダシル　23例

重症筋無力症（じゅうしょうきんむりょくしょう、Myasthenia Gravis; MG）とは、狭義にはニコチン性アセチルコリン受容体（神経伝達物質であるアセチルコリンの筋肉側における受け皿）に抗アセチルコリン受容体抗体が結合し、アセチルコリンによる神経・筋伝達を阻害するために筋肉の易疲労性や脱力が起こる自己免疫疾患である。日本では厚生労働省により特定疾患に指定されている難病である。主な診療科は神経内科である。

なお、広義にはMusk抗体由来症例や原因不明の類似症例等も重症筋無力症に含める場合もある。

症例（ガーダシル） スウェーデン

VAERS ID:

	513266 (history)	Vaccinated:	2012-11-08
Age:	13.0	Onset:	2013-03-01, Days after vaccination: 113
Gender:	Female	Submitted:	2013-11-15, Days after onset: 259
Location:	Foreign	Entered:	2013-11-15

	Life Threatening? No Died? No Permanent Disability? No Recovered? No ER or Doctor Visit? No Hospitalized? No Previous Vaccinations: Other Medications: Azithromycin; DOXYFERM; ERYMAX Current Illness: Immunisation Preexisting Conditions: 05/07/2012, GARDASIL, Immunisation; 03/14/2012, GARDASIL, Immunisation Diagnostic Lab Data: The patient was undergoing detailed investigation. Tests for CRP and blood status on 02-Apr-2013 and 10-Apr-2013 was without remarks. CRP on 17-Apr-2013 was also normal. Serology for Chlamydophila pneumonia was negative for IgM, but positive for IgG, as after previous infection. Lung X-ray 10-Apr-2013 without remark. Spirometry with reversible-test was performed on 17-Apr-2013 and showed no reversible obstructivity. ECG on 17-Apr-2013 without remarks. Echocardiography showed probable bicuspid aorta valve with minor insufficiency. Otherwise structurally normal heart with normal dimensions and normal function. Blood status and serology was tested (streptococcus, Borrelia, TBE, Mycoplasma, Chlamydia, Ehrlichiosis and HIV), TSH, T4, Iron, Ferri CDC Split Type: WAES1311SWE005727
Vaccination Manufacturer Lot Dose Route Site HPV4: HPV (GARDASIL) MERCK & CO. INC.   2 UN UN
Administered by: Other     Purchased by: Other Symptoms: Abnormal sensation in eye, Anti-transglutaminase antibody negative, Antiacetylcholine receptor antibody, Barotrauma, Blood 25-hydroxycholecalciferol decreased, Blood iron normal, Blood test normal, Blood zinc normal, Borrelia test, C-reactive protein normal, Chest X-ray abnormal, Chlamydia test positive, Computerised tomogram head normal, Computerised tomogram normal, Computerised tomogram thorax abnormal, Cough, Echocardiogram abnormal, Ehrlichia test, Electrocardiogram normal, Electroencephalogram normal, Electromyogram abnormal, Electroneurography, Erythema, Fatigue, Feeling cold, HIV test, Headache, Laryngoscopy normal, Lumbar puncture normal, Malaise, Mycoplasma test, Nuclear magnetic resonance imaging normal, Ophthalmological examination normal, Oropharyngeal pain, Pharyngoscopy, Photophobia, Post viral fatigue syndrome, Pyrexia, Red blood cell sedimentation rate normal, Serum ferritin normal, Spirometry normal, Streptococcus test, Vitamin B12 normal SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Cardiomyopathy (broad), Corneal disorders (broad), Retinal disorders (broad), Hypersensitivity (broad) Write-up: Case received from health care professional via Health Authorities on 08-Nov-2013 under the reference number SE-Medical Products Agency-2013-000064. The primary reporter as a physician. A 13-year-old female patient had received the third dose of GARDASIL (batch number not reported) on 08-Nov-2012 and later on 01-Mar-2013 she developed myalgic encephalomyelitis. It was reported that the female got unwell in March 2013 with cough, feeling unwell, feeling cold. In early April she developed sore throat. Later on she got worse with more severe tiredness. She had dry cough during the day, but less cough during nights. She suffered from airplane ear on her right ear. She suffered from headache, but mostly from pressure over the eyes. She was light sensitive. She felt feverish, but had max 38 degrees in the evening, but it might have been higher during the nights. The patient had received treatment with (reported as concomitant treatment) of Azithromycin (other mfr) 22-May-2013 to 30-May-2013 (discontinued 1 day early due to skin redness), ERY-MAX (other mfr) treatment in July 2013 (specific dates not rep) and DOXYFERM (other MFR) for 10 days in July 2013. The patient was undergoing detailed investigation. Tests for CRP and blood status on 02-Apr-2013 and 10-Apr-2013 was without remarks. CRP on 17-Apr-2013 was also normal. Serology for Chlamydophila pneumonia was negative for IgM, but positive for IgG, as after previous infection. Lung X-ray 10-Apr-2013 without remark. Spirometry with reversible-test was performed on 17-Apr-2013 and showed no reversible obstructivity. ECG on 17-Apr-2013 without remarks. Echocardiography showed probable bicuspid aorta valve with minor insufficiency. Otherwise structurally normal heart with normal dimensions and normal function. Blood status and serology was tested (streptococcus, Borrelia, TBE, Mycoplasma, Chlamydia, Ehrlichiosis and HIV), TSH, T4, Iron, Ferritin, Cobalamin, ESR (Erythrocyte sedimentation rate) and Zinc without remark, but 25-OH-D-vitamin slightly low: 53. Transglutaminase without remark (enzyme level normal). EnEG (Electro neurography) without remarks. I-EMG (integrated electromyography) on the border of myopathy; EEG, LP, MR and CT brain and MR of back without remarks. Acetylcholine receptor antibodies without remarks. Lung X-ray and CT showed discrete thickening of bronchial wall. Fiberscope epipharynx and larynx normal. Eye examination on 25-Jun-2013 without remark. Nasal NO on 28-Jun-2013 without remark. CT sinuses without remarks. Phoniatric examination on 19-Aug-2013 without remark. MR muscles without remark. The patient sought alternative treatment, including acupuncture and homeopathy. She has been examined at a specialist clinic 24-Oct-2013. The patient had previously received two doses of GARDASIL, on 14-Mar-2012 and 07-May-2012 (batch number or route not rep). HA considered all three doses of GARDASIL as suspect. According to the reporter, the mother of the patient strongly suspected the reactions were related to the vaccination. HA considered the drug reaction relatedness as not assessable. Upon medical review the company judged relevant to code the following adverse events: cough, feeling unwell, feeling cold, airplane ear, head pressure over the eyes, light sensitivity and fever which were mentioned by the HA in the narrative, but not coded. Outcome for these AE was not reported. At the time of reporting, the outcome of myalgic encephalomyelitis was unknown.

特発性血小板減少性紫斑病とピロリ菌 ガーダシル後

 

VAERS ID: 292253 (history)   Vaccinated: 2007-04-30 Age: 17.0   Onset: 2007-05-04, Days after vaccination: 4 Gender: Female   Submitted: 2007-09-28, Days after onset: 147 Location: New York   Entered: 2007-10-05, Days after submission: 7	Life Threatening? Yes Died? No Permanent Disability? No Recovered? No ER or Doctor Visit? Yes Hospitalized? No Previous Vaccinations: Other Medications: Current Illness: 10/7/06 - Virus 11/15/06 - Fever 5/4/07 Bruises Preexisting Conditions: None Diagnostic Lab Data: Chronic thrombocytopenia Low platelet count from (3,000) - no medication is causing remission 12/26/07-records received-a positive anti-gliadin antibody, a borderline H. Pylori serum antigen and a normal tissue transglutaminase.platelets fluctuate between 3 and 110. CDC Split Type:
Vaccination Manufacturer Lot Dose Route Site HPV4: HPV (GARDASIL) MERCK & CO. INC.     UN UN MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) SANOFI PASTEUR     UN UN
Administered by: Private     Purchased by: Private Symptoms: Antigliadin antibody positive, Contusion, Ecchymosis, Goitre, Helicobacter pylori identification test positive, Idiopathic thrombocytopenic purpura, Menstruation irregular, Petechiae, Platelet count decreased, Thrombocytopenia SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Accidents and injuries (narrow), Hypothyroidism (broad), Hyperthyroidism (broad), Fertility disorders (broad), Hypersensitivity (narrow) Write-up: Pronounced bruising then developed petechiae on ankles shoulders, neck, torso and face. Called Dr. (internist) in June-took blood 6/22/07-Blood work revealed thrombocytopenia at (8000) immediately went to Oncologist Dr. Levels went to (3,000) on (win Ro) Prednisone since 6/25 to present. 10/15/07-records received- office visit 5/4/07-C/O irregular menses. First and second doses of Gardisil no complaints. Note on 6/13/07-C/O easy bruising, dots on skin more on legs than anywhere else. Positive ecchymosis, petcchia. To see hematologist. 12/26/07-records received for DOS 6/25-11/9/07-Receiving WINRHO. Gastroenterology consultation 12/14/07-presented with ITP, No abdominal pain, fever, weight loss, early stiety, anoreixia, nausea, vomiting, melena, hematemesis, rectal bleed. PE: enlarged thyroid. Impression:eradicationof H. pylori may be associated with improvement of ITP. 1/12/2010 According to various health professionals. The Gardasil shots is the primary cause for my daughter''s immune dysfunction. My daughter did not have any prior illness that caused her present condition of (ITP).